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Completed

NCT Number: NCT03093792

Effects of Diet Manipulation on Women in the Curves Program

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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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

American Heart Association plus exercise

Other

Curves Complete - I plus exercise

Other

Curves Complete - II plus exercise

Other

Primary outcomes

  1. Effects of the Curves program on physical activity patterns

    Time frame: 24 weeks

  2. Effects of the Curves program on body weight

    Time frame: 24 weeks

  3. Effects of the Curves program on the hip/waist ratio

    Time frame: 24 weeks

  4. Effects of the Curves program on Resting Energy Expenditure (REE)

    Time frame: 24 weeks

  5. Effects of the Curves program on Blood Pressure (BP)

    Time frame: 24 weeks

  6. Effects of the Curves program on Heart Rate (HR)

    Time frame: 24 weeks

  7. Effects of the Curves program on body composition (DXA)

    Time frame: 24 weeks

  8. Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)

    Time frame: 24 weeks

  9. Effects of the Curves program on a chemistry-15 blood panel

    Time frame: 24 weeks

  10. Effects of the Curves program on a cell blood count (CBC) blood panel

    Time frame: 24 weeks

  11. Effects of the Curves program on lipid panels

    Time frame: 24 weeks

Secondary outcomes

  1. Effects of the Curves program on maximal cardiopulmonary capacity

    Time frame: 24 weeks

  2. Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test

    Time frame: 24 weeks

  3. Effects of the Curves program on muscular endurance through a maximal repetition test

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Curves International

Registry information

Official study 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

Acronym: Curves2

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2017
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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