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Completed

NCT Number: NCT04344821

Curves 30/30 Study

The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Exercise & Sport Nutrition Laboratory

College Station, Texas, 77843, United States

About this study

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 Laboratory (ESNL) 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 and diet program. The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is female;
  • Participant is post-menopausal;
  • Participant is between the ages of 18 and 45;
  • Participant is sedentary, overweight (BMI > 27) and post-menopausal;

Exclusion criteria

  • Participant has any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease;
  • Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
  • Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
  • Participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (i.e., creatine, HMB, etc.), anabolic/catabolic hormone levels (i.e., androstenedione, DHEA, etc.) or weight loss (i.e., ephedra, thermogenics, etc.) within three months prior to the start of the study;
  • Participant is consistently taking 500 mg or more of a Calcium supplement per day;
  • Participant is receiving Hormone Replacement Therapy (HRT);
  • Participant is involved in a planned exercise program within 3 - 6 months prior to the start of the study;
  • Participant has lost > 20 lbs. within the last 3 - 6 months;

Treatment and study plan

Curves Calcium

Dietary Supplement

Dietary Supplement: Curves Calcium

Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU 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)

Placebo

Dietary Supplement

Dextrose Placebo

Primary outcomes

  1. Body Composition: Body Fat

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  2. Body Composition: Fat Free Mass

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  3. Body Composition: Bone Mass

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  4. Body Composition: Fat Mass

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  5. Body Composition: Lean Mass

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  6. Body Composition: Body Weight

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    Changes in body composition (body weight) 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)

Secondary outcomes

  1. Energy Homeostasis: Resting Energy Expenditure (REE)

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    Changes in REE obtained via metabolic cart and expressed in absolute (kcal/d) and relative terms kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)

  2. Energy Homeostasis: Respiratory Exchange Ratio (RER)

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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 change from baseline with 95% confidence intervals (CI's)

  3. Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press

    Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months

    Changes in bench press 1 RM 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)

  4. Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press

    Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months

    Changes in bench press 1 RM 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)

  5. Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test

    Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months

    Changes in total repetitions at 80% of 1 RM 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)

  6. Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test

    Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months

    Changes in total repetitions at 80% of 1 RM 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)

  7. Cardiac Variable: Resting Electrocardiogram (ECG)

    Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months

    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)

  8. Cardiac Variable: Graded Exercise Test (GXT)

    Time frame: Measured prior to supplementation (Pre), and after 3, and 6 months

    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)

  9. Hemodynamic Variable: Resting Heart Rate (RHR)

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    Changes in resting heart rae (RHR) 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)

  10. Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  11. Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  12. Anthropometric Measures: Waist Circumference

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  13. Anthropometric Measures: Hip Circumference

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  14. Anthropometric Measures: Waist to Hip Ratio

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    Changes in the ratio of waist to hip (waist/hip circumference) 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)

  15. Fasting Glucose

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  16. Lipid Panel: Cholesterol

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  17. Lipid Panel: HDL Cholesterol

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  18. Lipid Panel: Cholesterol to HDL Ratio

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    Changes in cholesterol to HDL ratio 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)

  19. Lipid Panel: LDL Cholesterol

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

  20. Lipid Panel: Triglycerides

    Time frame: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

    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)

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Curves International

Registry information

Official study title

Effects of Repeated Short-Term Diets on Weight Loss in Women Participating in the Curves Fitness Program

Acronym: C-30

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 14, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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