Effects of Diet Manipulation on Women in the Curves Program
- Conditions
- Diet, Carbohydrate-Restricted
- Interventions
- Other: ControlOther: Curves Complete - I plus exerciseOther: American Heart Association plus exerciseOther: Curves Complete - II plus exercise
- Registration Number
- NCT03093792
- Lead Sponsor
- Texas A&M University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 86
- The participant is an apparently healthy female
- The participant is between the ages of 18 and 60
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control (no diet or exercise intervention) Curves Complete - I Curves Complete - I plus exercise (CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise) American Heart Association American Heart Association plus exercise (AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise) Curves Complete - II Curves Complete - II plus exercise (CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise)
- Primary Outcome Measures
Name Time Method Effects of the Curves program on body weight 24 weeks Effects of the Curves program on Blood Pressure (BP) 24 weeks Effects of the Curves program on a cell blood count (CBC) blood panel 24 weeks Effects of the Curves program on physical activity patterns 24 weeks Effects of the Curves program on Resting Energy Expenditure (REE) 24 weeks Effects of the Curves program on lipid panels 24 weeks Effects of the Curves program on body composition (DXA) 24 weeks Effects of the Curves program on Bioelectrical Impedance Analysis (BIA) 24 weeks Effects of the Curves program on the hip/waist ratio 24 weeks Effects of the Curves program on Heart Rate (HR) 24 weeks Effects of the Curves program on a chemistry-15 blood panel 24 weeks
- Secondary Outcome Measures
Name Time Method Effects of the Curves program on maximal cardiopulmonary capacity 24 weeks Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test 24 weeks Effects of the Curves program on muscular endurance through a maximal repetition test 24 weeks