A Clinical Study to Evaluate the Effect of a Modified Carbohydrate Diet on Body Weight in Overweight or Obese Men and Women

Provident Clinical Research0 sites86 target enrollmentApril 2004

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Provident Clinical Research
Enrollment: 86
Primary Endpoint: Differences between and within modified carbohydrate and portion-controlled (control) diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body weight.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to test the effects of a modified carbohydrate diet versus a portion controlled diet in overweight or obese men and women on body weight.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

December 2004

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Provident Clinical Research

Eligibility Criteria

Inclusion Criteria

•Men and women 18 to 65 years of age.
•Waist circumference measurement at Visit 1 (week -1) of ³ 87 cm for females and ³ 90 cm for males.
•Subject agrees to discontinue all use of supplements or multivitamins (except for those provided during study period) by Visit 2 (week 0).
•Normally active and judged to be in good health on the basis of medical history and routine laboratory tests.
•Subject must be willing to follow the assigned diet and maintain usual physical activity level throughout the trial.
•Subject understands the procedures and requirements of the study by providing written informed consent and authorization for protected health information disclosure.

Exclusion Criteria

•Weight loss of \> 10 lb in the two months prior to screening.
•Body mass index (BMI) \> 37.0 kg/m
•Current smoker (any cigarette use) or history of smoking within 6 months prior to screening.
•Postmenopausal women who are current users of hormone therapy or have discontinued hormone therapy within 2 months prior to screening.
•History or presence of significant cardiac, renal, hepatic, pulmonary, biliary, or endocrine disorders.
•Uncontrolled hypertension (systolic blood pressure ³ 160 mm Hg or diastolic blood pressure ³ 100 mm Hg on two consecutive visits).
•History of recurrent nephrolithiasis, or an acute episode of nephrolithiasis within the last year prior to screening.
•History of symptomatic cholelithiasis, unless subject has undergone cholecystectomy.
•History of gastrointestinal surgery for weight-reducing purposes.
•Active gastrointestinal disorders such as peptic ulcer disease or malabsorption syndromes (controlled lactose intolerance or gastroesophageal reflux disease are acceptable.)

Outcomes

Primary Outcomes

Differences between and within modified carbohydrate and portion-controlled (control) diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body weight.

Time Frame: week 12 and week 36

Secondary Outcomes

Differences between and within modified carbohydrate and control diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in body fat mass (FM).(wwek 12 and week 36)
Differences between and within modified carbohydrate and control diet treatment groups in the change from baseline (week 0) to week 12 and week 36 in trunk fat.(week 12 and week 36)