Diet, Carbohydrate-Restricted
Conditions
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).
Interventions
OTHERControl
OTHERAmerican Heart Association plus exercise
OTHERCurves Complete - I plus exercise
OTHERCurves Complete - II plus exercise
Sponsors
Curves International
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of the Curves program on lipid panels | 24 weeks |
| Effects of the Curves program on Bioelectrical Impedance Analysis (BIA) | 24 weeks |
| Effects of the Curves program on a chemistry-15 blood panel | 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 body weight | 24 weeks |
| Effects of the Curves program on the hip/waist ratio | 24 weeks |
| Effects of the Curves program on Resting Energy Expenditure (REE) | 24 weeks |
| Effects of the Curves program on Blood Pressure (BP) | 24 weeks |
| Effects of the Curves program on Heart Rate (HR) | 24 weeks |
| Effects of the Curves program on body composition (DXA) | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed