Effects of Diet Manipulation on Women in the Curves Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-01

Study Completion Date

2015-05-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Diet, Carbohydrate-Restricted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

(no diet or exercise intervention)

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

American Heart Association

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

Group Type EXPERIMENTAL

American Heart Association plus exercise

Intervention Type OTHER

Curves Complete - I

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

Group Type ACTIVE_COMPARATOR

Curves Complete - I plus exercise

Intervention Type OTHER

Curves Complete - II

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

Group Type ACTIVE_COMPARATOR

Curves Complete - II plus exercise

Intervention Type OTHER

Interventions

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Control

Intervention Type OTHER

American Heart Association plus exercise

Intervention Type OTHER

Curves Complete - I plus exercise

Intervention Type OTHER

Curves Complete - II plus exercise

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes