NCT00455065

Brief Summary

The purpose of this study is to determine if intake of whole grain foods as part of a hypocaloric diet enhances weight loss and improves cardiovascular disease risk factors in men and women with metabolic syndrome.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

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

August 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

March 30, 2007

Last Update Submit

August 16, 2023

Conditions

Metabolic Syndrome

Keywords

whole grainmetabolic syndromeweight loss

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

Secondary Outcomes (7)

  • Waist Circumference

  • Blood Pressure

  • Body fat percentage

  • Lipids and Lipoproteins

  • Glucose Tolerance (OGTT)

  • +2 more secondary outcomes

Interventions

Whole Grain FoodsBEHAVIORAL

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index (BMI) ≥ 30
  • at least three out of five ATP III criteria for metabolic syndrome. These criteria are defined as: \[1\] Triacylglycerol ≥150 mg/dL, \[2\] HDL \<40 mg/dL in men or \<50 mg/dL in women, \[3\] Fasting glucose ≥100 mg/dL, \[4\] Systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥85 mg/dL, and \[5\] waist circumference ≥102 cm in men or ≥88 cm in women.

You may not qualify if:

  • diagnosis of type I or II diabetes
  • diagnosis of CVD
  • diagnosis of cancer
  • diagnosis of any other serious medical condition
  • use of any medications that affect glucose, insulin, cholesterol, or reproductive hormones
  • smoker
  • drink more than 2 alcoholic beverages/d
  • consume a diet high in whole grains (\>3 servings/d)
  • pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Katcher HI, Legro RS, Kunselman AR, Gillies PJ, Demers LM, Bagshaw DM, Kris-Etherton PM. The effects of a whole grain-enriched hypocaloric diet on cardiovascular disease risk factors in men and women with metabolic syndrome. Am J Clin Nutr. 2008 Jan;87(1):79-90. doi: 10.1093/ajcn/87.1.79.

    PMID: 18175740DERIVED

MeSH Terms

Conditions

Metabolic SyndromeWeight Loss

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Penny M Kris-Etherton, Ph.D.

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 3, 2007

Study Start

August 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

August 21, 2023

Record last verified: 2023-08