Grains Reduce Adiposity and Improve Nutrition Study

NCT00924521 | Completed

• 1 other identifier: PKE GRAIN
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Whole grain intake beneficially affects body weight, body fat and glucose metabolism, and the investigators' previous work has shown that a high whole grain intake significantly reduced body fat in the abdominal region as measured by dual energy X-ray absorptiometry (DEXA) compared to a refined grain intake. Additional research is needed with regard to the mechanisms by which whole grains may affect visceral adiposity and the adipokines, which have been associated with risk for insulin resistance and type 2 diabetes. Therefore the proposed study aims to address these issues and in addition, includes exploratory work with adipocytes in cell culture to evaluate the effects of whole grains on adipocyte function. Hypothesis: There will be a greater reduction in visceral adiposity, indicators of insulin resistance (HOMA score), improvement in inflammatory status and improvement in adipokine levels after six weeks of a weight stable period and after six weeks of weight loss in subjects consuming 6-9 servings compared to 0 servings of whole grains per day.

Conditions

Metabolic Syndrome; Insulin Resistance

Keywords

grains; fiber; metabolic syndrome; insulin

Outcome Measures

Primary Outcomes (1)

• Body Composition

  To assess regional changes in body fat deposition, subjects will undergo a dual energy X-ray absorptiometry (DXA) scan at baseline (beginning of study) and end of each intervention period. Waist circumference measurements also will be taken at this time to track how much fat is lost from the abdominal area of the body.

  Week 6 and 12 - End of diet period 1 and 2

Secondary Outcomes (6)

• Fasting glucose

  Time 0, week 6 and week 14 - Baseline end of each diet period

• Plasma cytokines

  Week 0, week 6 and week 14 - Baseline end of each diet period

• Endothelial Health

  Week 0, week 6 and week 14 - Baseline end of each diet period

• Resting Metabolic Rate

  Week 0 and week 14 - Baseline and end of diet period 2

• Appetite Hormones

  Week 0, week 6 and week 14 - Baseline end of each diet period

Study Arms (2)

Refined grain

ACTIVE COMPARATOR

Participants in this group will receive only refined grains as typically consumed in the average American diet.

Dietary Supplement: Refined grain

Whole grain diet

EXPERIMENTAL

Participants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment.

Dietary Supplement: Whole grain diet

Interventions

Whole grain diet DIETARY_SUPPLEMENT

Participants in this group will receive 6-9 servings of whole grain daily to replace the refined grains typically included in the average American diet. Number of servings will depend upon calorie assignment.

Whole grain diet

Refined grain DIETARY_SUPPLEMENT

Participants in this group will receive only refined grains as typically consumed in the average American diet.

Refined grain

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \> 25 to \< 42
• Waist circumference of \> 40 inches for males and \> 35 inches for females and having one other of the criteria for metabolic syndrome will be recruited
• In this population, we will also accept the following:
• LDL-C \< 175 mg/dL
• HDL-C \> 25 mg/dL
• Triglycerides \< 400 mg/dL
• All subjects will be required to meet one specific criteria for metabolic syndrome beyond increased waist circumference

You may not qualify if:

• Smokers
• Have insulin-dependent diabetes
• Are pregnant or expecting to be pregnant, lactating in the last 6 months
• Are taking NSAIDS or other medications known to affect inflammatory markers or drugs affecting glucose metabolism
• Blood pressure lowering medications are acceptable if the person has controlled BP at screening, \<140/90 mmHg.

Sponsors & Collaborators

• Penn State University: lead
• General Mills: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (2)

• 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: 18175740 RESULT

• Harris Jackson K, West SG, Vanden Heuvel JP, Jonnalagadda SS, Ross AB, Hill AM, Grieger JA, Lemieux SK, Kris-Etherton PM. Effects of whole and refined grains in a weight-loss diet on markers of metabolic syndrome in individuals with increased waist circumference: a randomized controlled-feeding trial. Am J Clin Nutr. 2014 Aug;100(2):577-86. doi: 10.3945/ajcn.113.078048. Epub 2014 Jun 18.

  PMID: 24944054 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Penny M Kris-Etherton, PhD

  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: June 18, 2009
• First Posted: June 19, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)