NCT Number: NCT03878667
The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.
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Notify Me45 year–65 year
Female
Interventional
Not applicable
The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise & Sport Nutrition Lab at Texas A&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. However, we feel that the program may be even more effective with some additional nutritional interventions. Calcium has been shown to slow bone loss and more recently has been found to help promote fat loss. If this is the case, supplementing the diet with calcium may promote greater benefits in women participating in the Curves fitness/diet program. The purpose of this study is to examine the effect of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
Calcium (providing 950 mg/d as carbonate)
Dextrose placebo
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (fat free mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (bone mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (fat mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body composition (lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body weight (lbs. body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in REE obtained via metabolic cart and expressed in absolute (kcals/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in RER as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in bench press 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in leg press 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in total repetitions at 80% of 1RM obtained from a bench press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in total repetitions at 80% of 1RM obtained from a leg press test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in body water obtained via Bioelectrical Impedance Analysis (BIA) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in HDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in LDL cholesterol obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in triglycerides obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in glucose obtained via venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in calcium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in albumin obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in total protein obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in sodium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in potassium obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in carbon dioxide (CO2) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in chloride obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in blood urea nitrogen (BUN) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in creatinine obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in alkaline phosphatase (ALP) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in alanine amino transferase (ALT) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in alanine amino transferase (ALT) obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in bilirubin obtained via venous blood draws (comprehensive metabolic panel - CMP) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in white blood cell count (WBC) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in white blood cell differential obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in red blood cell count obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in red cell distribution width (RDW) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in hemoglobin obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in hematocrit obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in platelet count obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean platelet volume (MPV) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in neutrophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in lymphocytes obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in basophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in eosinophils obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in monocytes obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean corpuscular volume (MCV) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean corpuscular hemoglobin (MCH) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in mean corpuscular hemoglobin concentration (MCHC) obtained via venous blood draws (complete blood count - CBC) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in serum insulin obtained from venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in serum leptin obtained from venous blood draws and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in resting heart rate (HR) obtained via a blood pressure meter and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in resting systolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in resting diastolic blood pressure (mmHg) analyzed with related resting hemodynamic outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in waist circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in hip circumference obtained via tape measure and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in the ratio of waist to hip (waist/hip circumference) analyzed with related anthropometric outcomes measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in body mass index (kg of body mass/height in meters squared) analyzed with related anthropometric outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in resting ECG obtained via electrodes and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Changes in exercise capacity obtained via a treadmill test and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Changes in Quality of Life (QOL) obtained via SF36v2 questionnaire and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's). The SF-36 QOL inventory provides scores that assess physical functioning (i.e., ability to perform most vigorous physical activities without limitation to health); role physical (i.e., ability to work and perform daily activities); bodily pain (i.e., limitations due to pain); general health (i.e., assessment of personal health); vitality (i.e., feelings of energy); social functioning (i.e., ability to perform normal social activities); role emotion (i.e., problems with work or other daily activities); and, mental health (state of feelings of peacefulness, happiness, and calm) domains on a 0 (low) to 100 (high scale.
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of appetite using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of hunger using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of satisfaction from food using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of feelings of fullness using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of amount of energy using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of overall quality of diet using the following scale: 0 (none), 1 - 3 (low), 4 - 6 (moderate), 7 - 9 (high), 10 (severe). Data will be analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in caloric/energy intake (kcals/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in dietary carbohydrate intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in dietary fat intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in dietary protein intake (grams/day and grams/kg/day) analyzed with related energy intake outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of dizziness using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of headache using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of tachycardia using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of palpitations using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of dyspnea using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of nervousness using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of blurred vision using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Time frame: Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Change in perceptions of other side effects using a Likert scale [0 (none), 1 - 4 (light), 5 - 6 (mild), 7 - 9 (severe), or 10 (very severe)] and analyzed with related side effect outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Texas A&M University
Other
Effects of Calcium Supplementation on Body Composition, Metabolism and Exercise Capacity in Post-Menopausal Women Participating in the Curves for Women Fitness and Weight Loss Program
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