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Effects of Diet Manipulation on Women in the Curves Program

Not Applicable
Completed
Conditions
Diet, Carbohydrate-Restricted
Interventions
Other: Control
Other: Curves Complete - I plus exercise
Other: American Heart Association plus exercise
Other: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlControl(no diet or exercise intervention)
Curves Complete - ICurves Complete - I plus exercise(CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise)
American Heart AssociationAmerican Heart Association plus exercise(AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise)
Curves Complete - IICurves Complete - II plus exercise(CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise)
Primary Outcome Measures
NameTimeMethod
Effects of the Curves program on body weight24 weeks
Effects of the Curves program on Blood Pressure (BP)24 weeks
Effects of the Curves program on a cell blood count (CBC) blood panel24 weeks
Effects of the Curves program on physical activity patterns24 weeks
Effects of the Curves program on Resting Energy Expenditure (REE)24 weeks
Effects of the Curves program on lipid panels24 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 ratio24 weeks
Effects of the Curves program on Heart Rate (HR)24 weeks
Effects of the Curves program on a chemistry-15 blood panel24 weeks
Secondary Outcome Measures
NameTimeMethod
Effects of the Curves program on maximal cardiopulmonary capacity24 weeks
Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test24 weeks
Effects of the Curves program on muscular endurance through a maximal repetition test24 weeks
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