NCT Number: NCT03093792
Effects of Diet Manipulation on Women in the Curves Program
The purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss Program.
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Conditions
Age range
18 year–60 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
The purpose of this study is to determine if a carbohydrate restricted, high protein, high fat diet (20% carbohydrate, 45% protein, 35% fat; CC-II) promotes more favorable changes in weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low fat diet (55% carbohydrate, 15% protein, 30% fat; AHA) and the Curves moderate carbohydrate restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; CC-I).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The participant is an apparently healthy female
- The participant is between the ages of 18 and 60
Exclusion criteria
- The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
- The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
- The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
- The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
- The participant is willing to participate in a regular moderate exercise program
Treatment and study plan
American Heart Association plus exercise
OtherCurves Complete - I plus exercise
OtherCurves Complete - II plus exercise
OtherPrimary outcomes
-
Effects of the Curves program on physical activity patterns
Time frame: 24 weeks
-
Effects of the Curves program on body weight
Time frame: 24 weeks
-
Effects of the Curves program on the hip/waist ratio
Time frame: 24 weeks
-
Effects of the Curves program on Resting Energy Expenditure (REE)
Time frame: 24 weeks
-
Effects of the Curves program on Blood Pressure (BP)
Time frame: 24 weeks
-
Effects of the Curves program on Heart Rate (HR)
Time frame: 24 weeks
-
Effects of the Curves program on body composition (DXA)
Time frame: 24 weeks
-
Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)
Time frame: 24 weeks
-
Effects of the Curves program on a chemistry-15 blood panel
Time frame: 24 weeks
-
Effects of the Curves program on a cell blood count (CBC) blood panel
Time frame: 24 weeks
-
Effects of the Curves program on lipid panels
Time frame: 24 weeks
Secondary outcomes
-
Effects of the Curves program on maximal cardiopulmonary capacity
Time frame: 24 weeks
-
Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test
Time frame: 24 weeks
-
Effects of the Curves program on muscular endurance through a maximal repetition test
Time frame: 24 weeks
Sponsors and collaborators
Lead sponsor
Texas A&M University
Other
Collaborators
- Curves International
Registry information
Official study title
Effects of a Carbohydrate Restricted, High Protein, High Fat Diet on Weight Loss and Health Outcomes in Women Participating in the Curves Fitness and Weight Loss Program
Acronym: Curves2
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Mar 28, 2017
- Registry last updated
- Mar 28, 2017
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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