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The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
California Walnut Commission
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00525629
First received: September 5, 2007
Last updated: May 5, 2011
Last verified: May 2011
History of Changes
  Purpose

Walnuts include many potentially beneficial micronutrients and phytochemicals, in this study we propose to examine the effects of walnuts independent of macronutrient content. The purpose of this proposal is to study in depth the short-term effects of walnut consumption in men and women with the metabolic syndrome.

Study Aim 1: To investigate the effects of walnuts (48gms per day over 3 days) on insulin resistance in subjects with the metabolic syndrome.

Study Aim 2: To investigate the effects of 48gms per day of walnuts over 3 days on lipids and inflammatory markers.

Study Aim 3: To assess the possible mechanisms of the biological effects of short-term walnut consumption through assessment of adipokines, resting metabolic rate, gene expression in white blood cells and the effect of walnuts when consumed as part of a mixed meal, on glucose excursions, insulin secretion and the excretion of gut peptides and free fatty acids.


Condition Intervention Phase
Metabolic Syndrome
Type 2 Diabetes
Cardiovascular Disease
 Dietary Supplement: Walnuts
Dietary Supplement: Control
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Metabolic Effects of Short-term Walnut Consumption in Subjects With the Metabolic Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Insulin Resistance [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Walnut Diet
48 Grams of Walnuts Daily
 Dietary Supplement: Walnuts
48 Grams of Walnuts Daily
Other Name: walnuts
Placebo Comparator: Control Diet
Isocaloric Diet with No Walnuts
 Dietary Supplement: Control
Control Diet with No Walnuts

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Metabolic Syndrome is defined as follows:

Central Obesity- for Europid men this is a waist circumference of > 94cm for women >80cm or BMI >30.

Plus 2 of the following 4 factors

  1. Elevated triglycerides: > 150 mg/dL
  2. Reduced HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women.
  3. Raised diastolic blood pressure systolic BP > 130mmHg or diastolic BP > 85mmHg or treatment with antihypertensives.
  4. Raised fasting plasma glucose > 100mg/dL or previously diagnosed type II diabetes.

Exclusion Criteria:

  1. Subjects with diabetes requiring medication or insulin are excluded.
  2. Subjects with any medical condition or on any treatment, which would interfere with the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, anemia, heart disease, stroke, malabsorption syndromes according to a detailed medical history.
  3. Present alcoholism or drug abuse or use of medications that could interfere with the study such as corticosteroids, growth hormone, antiretroviral therapy. These conditions will be screened for by a detailed history and systems review.
  4. Individuals with nut allergy are excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525629

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
California Walnut Commission
Investigators
Principal Investigator: Christos S Mantzoros, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided by Beth Israel Deaconess Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christos Mantzoros, Harvard Medical School/Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00525629     History of Changes
Other Study ID Numbers: 2006P000255
Study First Received: September 5, 2007
Last Updated: May 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 19, 2013