Clinical trial NCT03093792: Effects of Diet Manipulation on Women in the Curves Program
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Carbohydrate-Restricted
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Curves International
First posted: 2017-03-28
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effects of the Curves program on physical activity patterns
timeFrame: 24 weeks
measure: Effects of the Curves program on body weight
timeFrame: 24 weeks
measure: Effects of the Curves program on the hip/waist ratio
timeFrame: 24 weeks
measure: Effects of the Curves program on Resting Energy Expenditure (REE)
timeFrame: 24 weeks
measure: Effects of the Curves program on Blood Pressure (BP)
timeFrame: 24 weeks
measure: Effects of the Curves program on Heart Rate (HR)
timeFrame: 24 weeks
measure: Effects of the Curves program on body composition (DXA)
timeFrame: 24 weeks
measure: Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)
timeFrame: 24 weeks
measure: Effects of the Curves program on a chemistry-15 blood panel
timeFrame: 24 weeks
measure: Effects of the Curves program on a cell blood count (CBC) blood panel
timeFrame: 24 weeks
measure: Effects of the Curves program on lipid panels
timeFrame: 24 weeks
Secondary outcomes:
measure: Effects of the Curves program on maximal cardiopulmonary capacity
timeFrame: 24 weeks
measure: Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test
timeFrame: 24 weeks
measure: Effects of the Curves program on muscular endurance through a maximal repetition test
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References: