| July 11, 2006 |
| April 21, 2009 |
| April 2004 |
| November 2004 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| 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. |
| Complete list of historical versions of study NCT00351845 on ClinicalTrials.gov Archive Site |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
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- 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).
- 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.
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| |
| Clinical Study to Test the Effects of a Low-Carbohydrate Diet on Body Weight |
| 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. |
| |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| Obesity |
| Behavioral: Low carbohydrate diet (behavior) |
| |
| |
| |
| Completed |
| 86 |
| December 2004 |
| November 2004 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 65 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00351845 |
| Kevin C. Maki, PhD, Provident Clinical Research |
| 203470 |
| Provident Clinical Research |
|
| Principal Investigator: |
Kevin C Maki, PhD |
Radiant Research Chicago |
|
|
| Provident Clinical Research |
| April 2009 |