NCT01051674

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for phase_4 obesity

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

January 14, 2010

Last Update Submit

June 27, 2014

Conditions

ObesityType 2 Diabetes

Keywords

ObesityType 2 diabetesFiberDietary fiberLow-carbohydrate dietHigh protein diet

Outcome Measures

Primary Outcomes (1)

  • Weight

    1 year

Secondary Outcomes (7)

  • Lipid profiles

    1 year

  • Gastrointestinal hormones

    1 year

  • Waist circumference

    1 year

  • C-reactive protein

    1 year

  • Blood glucose

    1 year

  • +2 more secondary outcomes

Study Arms (2)

High fiber diet

EXPERIMENTAL
Other: High fiber vs. low-carbohydrate diets

Low-carbohydrate diet

EXPERIMENTAL
Other: High fiber vs. low-carbohydrate diets

Interventions

High fiber vs. low-carbohydrate dietsOTHER

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.

High fiber dietLow-carbohydrate diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda U Medical Center Diabetes Treatment Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Serena Tonstad, MD, PhD, MPH

    Loma Linda University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 18, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

US(1)