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A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Loma Linda University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Lifestyle Center of America
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01051674
First received: January 14, 2010
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

Using a 2x2 complete factorial design, approximately 140 obese men and women who may or may not have type 2 diabetes will be randomized to one of two conditions (70 in each condition): (a) a high fiber diet, or (b) a low-carbohydrate diet. Participants will be instructed to follow their assigned diets for 1 year. Outcome measures of interest will include participants' BMI, waist circumference, blood lipids (total, HDL, and LDL cholesterol, and triglycerides), C-reactive protein, and gastrointestinal peptides. Participants will be recruited from the Loma Linda and San Bernardino city area in southern California.


Condition Intervention Phase
Obesity
Type 2 Diabetes
 Other: High fiber vs. low-carbohydrate diets
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid profiles [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Gastrointestinal hormones [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Blood glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum insulin [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 173
Study Start Date: January 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High fiber diet Other: High fiber vs. low-carbohydrate diets
High fiber diet involves at least 40 grams of dietary fiber or more per day for women and at least 50 grams of dietary fiber per day for men. Low-carbohydrate diet involves less than 120 grams of carbohydrate per day for both men and women.
Experimental: Low-carbohydrate diet Other: High fiber vs. low-carbohydrate diets
High fiber diet involves at least 40 grams of dietary fiber or more per day for women and at least 50 grams of dietary fiber per day for men. Low-carbohydrate diet involves less than 120 grams of carbohydrate per day for both men and women.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 30.0-42.0 kg/m2
  • English-speaking

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Acute or chronic infection
  • Type 1 diabetes
  • Participation in another trial
  • Active cancers
  • Currently using Byetta
  • Currently on weight loss medication
  • Weight loss of more than 4 lbs. within the last 3 months
  • Vegan
  • Active eating disorder
  • Gastrointestinal problems that may be worsened by a high fiber intake
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051674

Locations
United States, California
Loma Linda U Medical Center Diabetes Treatment Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Lifestyle Center of America
Investigators
Study Chair: Serena Tonstad, MD, PhD, MPH Loma Linda University
  More Information

No publications provided

Responsible Party: Serena Tonstad, MD, PhD, MPH, Loma Linda U School of Public Health, Department of Health Promotion & Education
ClinicalTrials.gov Identifier: NCT01051674     History of Changes
Other Study ID Numbers: 59217
Study First Received: January 14, 2010
Last Updated: May 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Obesity
Type 2 diabetes
Fiber
 Dietary fiber
Low-carbohydrate diet
High protein diet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 22, 2013