- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00351845
Clinical Study to Test the Effects of a Low-Carbohydrate Diet on Body Weight
April 21, 2009 updated by: Provident Clinical Research
A Clinical Study to Evaluate the Effect of a Modified Carbohydrate Diet on Body Weight in Overweight or Obese Men and Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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/m2.
- 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.)
- Pancreatic disease: pancreatic enzyme deficiency, history of pancreatitis.
- Fasting blood glucose ≥ 126 mg/dL at visit 1 or diagnosed diabetes mellitus.
- Use of any weight loss medications, supplements, programs, or meal replacement products intended to alter body weight within 4 weeks of the screening visit or during the course of the study. Occasional use of meal replacement bars or shakes as snacks is acceptable.
- History or presence of cancer in the past 2 years, except for successfully resected basal cell carcinoma of the skin.
- Psychiatric disorders requiring medications (i.e., selective serotonin reuptake inhibitors) or which could interfere with the subject's compliance to the requirements of the protocol.
- History or current presence of any diagnosed eating disorders (binge eating, bulimia, history of anorexia).
- Use of systemic corticosteroids, androgens, or phenytoin.
- Use of pseudo-ephedrine during the study period.
- Use of lipid-lowering drugs or supplements, unless dose stable prior to enrollment (2 months prior for drugs, 2 weeks prior for supplements).
- Use of drugs for regulating hemostasis, other than stable dose aspirin.
- Use of thyroid hormones, except stable-dose replacement therapy for ≥ 2 months prior to enrollment.
- Abnormal laboratory test results of clinical significance, including, but not limited to total cholesterol > 300 mg/dL or triglycerides > 400 mg/dL.
- Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are not using an approved method of contraception. A woman is considered to be of childbearing potential unless she is post-hysterectomy, post-tubal ligation, or ³ 1 year postmenopausal.
- Recent history of (within past 12 months) or strong potential for alcohol or substance abuse. Alcohol abuse will be defined as > 14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1 ½ oz distilled spirits).
- Participation in another clinical study within 30 days prior to screening visit (week -1).
- Individual has a condition the Investigator believes would interfere with the evaluation of the subject or put the subject at undue risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
week 12 and week 36
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
Time Frame: wwek 12 and week 36
|
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.
Time Frame: week 12 and week 36
|
week 12 and week 36
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kevin C Maki, PhD, Radiant Research Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
November 1, 2004
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
July 11, 2006
First Submitted That Met QC Criteria
July 11, 2006
First Posted (Estimate)
July 13, 2006
Study Record Updates
Last Update Posted (Estimate)
April 22, 2009
Last Update Submitted That Met QC Criteria
April 21, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 203470
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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