NCT00622960

Brief Summary

The purpose of this proposed randomized, controlled trial is to compare the effects of high monounsaturated fat diets and high carbohydrate diets on body weight, body composition, glycemic control, plasma lipids, and other cardiovascular risk factors over a period of one year. At present, no such studies of free-living subjects have been performed. The specific aims of the proposed project are to test the hypotheses that (1) a high monounsaturated fat diet will produce greater weight loss/body fat loss and more successful weight maintenance than a high carbohydrate diet and (2) a high monounsaturated fat diet will result in an improved lipid profile and better glycemic control than a high carbohydrate diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2004

Typical duration for phase_1

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

April 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
Last Updated

February 25, 2008

Status Verified

February 1, 2008

Enrollment Period

3 years

First QC Date

February 13, 2008

Last Update Submit

February 22, 2008

Conditions

OverweightObesityType 2 Diabetes

Keywords

obesitytype 2 diabetesweight lossmonounsaturated fatdiet

Outcome Measures

Primary Outcomes (1)

  • body weight

    prior to and after 4, 8, and 12 months of dieting

Secondary Outcomes (4)

  • body fat

    prior to and after 4, 8, and 12 months of dieting

  • blood pressure

    prior to and after 4, 8, and 12 months of dieting

  • blood lipid profile

    prior to and after 4, 8, and 12 months of dieting

  • glycemic control (glucose, insulin, and HbA1c)

    prior to and after 4, 8, and 12 months of dieting

Study Arms (2)

High MUFA diet

EXPERIMENTAL

Those subjects assigned to a high monounsaturated fat diet

Other: High-MUFA diet

High CHO diet

ACTIVE COMPARATOR

Those subjects assigned to a high carbohydrate diet

Other: High-CHO diet

Interventions

High-MUFA dietOTHER

The effects of high monounsaturated fat diet on body weight, body composition, lipid profile, and glycemic control.

High MUFA diet
High-CHO dietOTHER

The effects of high carbohydrate diet on body weight, body composition, lipid profile, and glycemic control.

High CHO diet

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 27-40 kg/m2
  • years of age
  • Stable body weight for the preceding 6 months
  • Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
  • HbA1c of 6.5 to 9.0
  • Treatment by diet or oral agents only

You may not qualify if:

  • Pregnancy or lactation
  • Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
  • Untreated thyroid disease or hypertension
  • Hypertriglyceridemia with levels of TG \> 500 mg/dl
  • Use of insulin
  • Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
  • Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Related Publications (1)

  • Brehm BJ, Lattin BL, Summer SS, Boback JA, Gilchrist GM, Jandacek RJ, D'Alessio DA. One-year comparison of a high-monounsaturated fat diet with a high-carbohydrate diet in type 2 diabetes. Diabetes Care. 2009 Feb;32(2):215-20. doi: 10.2337/dc08-0687. Epub 2008 Oct 28.

    PMID: 18957534DERIVED

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2Weight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBody Weight Changes

Study Officials

  • Bonnie J Brehm, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 25, 2008

Study Start

April 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

February 25, 2008

Record last verified: 2008-02

Locations

US(1)