NCT00508937

Brief Summary

The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Moreover, we will test whether such diets result in beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are also independent of saturated fat intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

2.8 years

First QC Date

July 26, 2007

Last Update Submit

December 22, 2020

Conditions

Insulin ResistanceType 2 DiabetesMetabolic SyndromeCardiovascular DiseaseDyslipidemia

Keywords

DietProteinGlucoseInsulinCholesterolTriglyceridesLDL subclasses

Outcome Measures

Primary Outcomes (7)

  • Insulin Sensitivity by Frequently Sampled Intravenous Glucose Tolerance test

    4wks and 8wks

  • Total Cholesterol

    4wks and 8wks

  • LDL Cholesterol

    4wks and 8wks

  • HDL Cholesterol

    4wks and 8wks

  • Triglycerides

    4wks and 8wks

  • LDL peak particle size

    4wks and 8wks

  • LDL subclasses

    4wks and 8wks

Secondary Outcomes (2)

  • Apolipoprotein B

    4wks and 8wks

  • Apolipoprotein A1

    4wks and 8wks

Study Arms (5)

1

ACTIVE COMPARATOR
Other: Diet

2

EXPERIMENTAL
Other: Diet

3

EXPERIMENTAL
Other: Diet

4

EXPERIMENTAL
Other: Diet

5

EXPERIMENTAL
Other: Diet

Interventions

DietOTHER

15% protein, 55% carbohydrate, 30% fat (7% saturated, 7% polyunsaturated)

1

Eligibility Criteria

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

You may qualify if:

  • Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2
  • HOMA-IR ≥ 2.5
  • Non-smoking
  • Total cholesterol and LDL cholesterol \<95th percentile for sex and age
  • Fasting triglycerides \< 500mg/dl
  • Fasting blood sugar \< 126
  • Urinary microalbumin \< 30 mg/L
  • Normal thyroid stimulating hormone levels
  • Hematocrit ≥ 36%
  • Blood pressure \< 150/90
  • At least 3 months of a weight-stable state (± 5 lbs) prior to the study. During the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase

You may not qualify if:

  • History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years
  • Use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
  • Use of alcohol or dietary supplements during the study
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cholesterol Research Center

Berkeley, California, 94705, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Chiu S, Williams PT, Dawson T, Bergman RN, Stefanovski D, Watkins SM, Krauss RM. Diets high in protein or saturated fat do not affect insulin sensitivity or plasma concentrations of lipids and lipoproteins in overweight and obese adults. J Nutr. 2014 Nov;144(11):1753-9. doi: 10.3945/jn.114.197624. Epub 2014 Sep 3.

    PMID: 25332473DERIVED

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus, Type 2Metabolic SyndromeCardiovascular DiseasesDyslipidemias

Interventions

Diet

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ronald M Krauss, M.D.

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 30, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

December 23, 2020

Record last verified: 2020-12

Locations

US(2)