NCT00525629

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

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

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8.2 years until next milestone

Results Posted

Study results publicly available

February 23, 2017

Completed
Last Updated

December 15, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

September 5, 2007

Results QC Date

January 5, 2017

Last Update Submit

June 21, 2017

Conditions

Metabolic SyndromeType 2 DiabetesCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Insulin Resistance

    HOMA-IR (homeostatic model assessment of insulin resistance) given in units as it is a ratio equation.

    4 days

Study Arms (2)

Walnut Diet

EXPERIMENTAL

48 Grams of Walnuts Daily

Dietary Supplement: Walnuts

Control Diet

PLACEBO COMPARATOR

Isocaloric Diet with No Walnuts

Dietary Supplement: Control

Interventions

WalnutsDIETARY_SUPPLEMENT

48 Grams of Walnuts Daily

Walnut Diet
ControlDIETARY_SUPPLEMENT

Control Diet with No Walnuts

Control Diet

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects with diabetes requiring medication or insulin are excluded.
  • 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.
  • 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.
  • Individuals with nut allergy are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Brennan AM, Sweeney LL, Liu X, Mantzoros CS. Walnut consumption increases satiation but has no effect on insulin resistance or the metabolic profile over a 4-day period. Obesity (Silver Spring). 2010 Jun;18(6):1176-82. doi: 10.1038/oby.2009.409. Epub 2009 Nov 12.

    PMID: 19910942DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Results Point of Contact

Title
Christos Mantzoros
Organization
Beth Israel Deaconess Medical Center
cmantzor@bidmc.harvard.edu
617-667-8630

Study Officials

  • Christos S Mantzoros, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 6, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 15, 2017

Results First Posted

February 23, 2017

Record last verified: 2017-06

Locations

US(1)