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

NCT00351845 | Completed

• 1 other identifier: 203470
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  week 12 and week 36

Secondary Outcomes (2)

• 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

Interventions

Low carbohydrate diet (behavior) BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Provident Clinical Research: lead

MeSH Terms

Conditions

Obesity

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Kevin C Maki, PhD

  Radiant Research Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 13, 2006
• Study Start: April 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: December 1, 2004
• Last Updated: April 22, 2009

Record last verified: 2009-04