Clinical Study to Test the Effects of a Low-Carbohydrate Diet on Body Weight

This study has been completed.
Information provided by:
Provident Clinical Research Identifier:
First received: July 11, 2006
Last updated: April 21, 2009
Last verified: April 2009

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.

Condition Intervention
Behavioral: Low carbohydrate diet (behavior)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate the Effect of a Modified Carbohydrate Diet on Body Weight in Overweight or Obese Men and Women

Resource links provided by NLM:

Further study details as provided by Provident Clinical Research:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 86
Study Start Date: April 2004
Study Completion Date: December 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00351845

Sponsors and Collaborators
Provident Clinical Research
Principal Investigator: Kevin C Maki, PhD Radiant Research Chicago
  More Information

No publications provided

Responsible Party: Kevin C. Maki, PhD, Provident Clinical Research Identifier: NCT00351845     History of Changes
Other Study ID Numbers: 203470
Study First Received: July 11, 2006
Last Updated: April 21, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Nutrition Disorders
Overweight processed this record on April 15, 2014