Effects of Diet Manipulation on Women in the Curves Program (Curves2)

Texas A&M University

Status: Completed

Conditions: Diet, Carbohydrate-Restricted

Treatments: Other: Curves Complete - II plus exercise; Other: American Heart Association plus exercise; Other: Control; Other: Curves Complete - I plus exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03093792

IRB2013-0495FX

Details and patient eligibility

About

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.

Full 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).

Enrollment: 86 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

(no diet or exercise intervention)

Treatment:

Other: Control

American Heart Association

Experimental group

Description:

(AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise)

Treatment:

Other: American Heart Association plus exercise

Curves Complete - I

Active Comparator group

Description:

(CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise)

Treatment:

Other: Curves Complete - I plus exercise

Curves Complete - II

Active Comparator group

Description:

(CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise)

Treatment:

Other: Curves Complete - II plus exercise