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OpenTrials
Completed

NCT Number: NCT01051674

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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Loma Linda U Medical Center Diabetes Treatment Center

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High fiber vs. low-carbohydrate diets

Other

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.

Primary outcomes

  1. Weight

    Time frame: 1 year

Secondary outcomes

  1. Lipid profiles

    Time frame: 1 year

  2. Gastrointestinal hormones

    Time frame: 1 year

  3. Waist circumference

    Time frame: 1 year

  4. C-reactive protein

    Time frame: 1 year

  5. Blood glucose

    Time frame: 1 year

  6. Serum insulin

    Time frame: 1 year

  7. Hemoglobin A1c

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Lifestyle Center of America

Registry information

Official study title

A Very High Fiber Diet Versus a Low-carbohydrate Diet for Weight Loss in Obese Individuals With or Without Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 18, 2010
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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