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

This study has been completed.
Sponsor:
Collaborator:
Lifestyle Center of America
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01051674
First received: January 14, 2010
Last updated: June 27, 2014
Last verified: June 2014

January 14, 2010
June 27, 2014
January 2010
September 2011   (final data collection date for primary outcome measure)
Weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01051674 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss
A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Type 2 Diabetes
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: High fiber diet
    Intervention: Other: High fiber vs. low-carbohydrate diets
  • Experimental: Low-carbohydrate diet
    Intervention: Other: High fiber vs. low-carbohydrate diets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01051674
59217
No
Loma Linda University
Loma Linda University
Lifestyle Center of America
Study Chair: Serena Tonstad, MD, PhD, MPH Loma Linda University
Loma Linda University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP