NCT00901043

Brief Summary

The purpose of this study is to examine the effects of sustained walnut consumption on endothelial function and lipid markers in patients with Type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable diabetes-mellitus-type-2

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

October 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

May 12, 2009

Last Update Submit

March 25, 2020

Conditions

DIABETES MELLITUS TYPE 2

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow mediated dilation (FMD)

    8 weeks

Secondary Outcomes (1)

  • Change in weight, waist circumference, blood pressure, fasting lipids, fasting insulin, HBA1c and glucose levels

    8 weeks

Study Arms (2)

Walnut supplementation

EXPERIMENTAL

Eight weeks with walnut supplementation to an ad lib diet

Dietary Supplement: Walnut supplementation

Ad lib diet

ACTIVE COMPARATOR

Eight weeks ad lib diet without walnut supplementation

Dietary Supplement: Ad lib diet

Interventions

Walnut supplementationDIETARY_SUPPLEMENT

Eight weeks of walnut supplementation

Walnut supplementation
Ad lib dietDIETARY_SUPPLEMENT

Eight weeks without walnut supplementation

Ad lib diet

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women ages 35-75
  • non-smoker
  • able to have blood pressure taken bilaterally
  • diagnosed with type 2 diabetes by physician for at least one year
  • stable glucose levels and medication dose for the past 3 months
  • not on insulin therapy

You may not qualify if:

  • anticipated inability to complete or comply with study protocol for any reason (e.g., inability to communicate in English, dementia) or any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., wasting illness, AIDS, tuberculosis, psychotic disorder)
  • diagnosed eating disorder
  • use of lipid-lowering or antihypertensive medications (statins, red rice yeast extract, garlic) unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to endothelial function (EF) scanning, vasoactive medication (i.e., glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutriceuticals
  • regular use of multivitamins and/or complementary or alternative supplement therapy and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration
  • any rheumatologic disease requiring regular use of nonsteroidal antiinflammatory drug (NSAIDs) or alternative medications
  • regular use of fiber supplements
  • preexisting cardiovascular disease, including symptomatic coronary artery disease (CAD), myocardial infarction, angina pectoris, anginal equivalent, peripheral vascular disease (claudication, amputation, or revascularization) congestive heart failure, carotid stenosis, aortic stenosis or stroke; diabetes, sleep apnea, severe uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 105 mmHg)
  • coagulopathy, known bleeding diathesis or history of clinically significant hemorrhage; current use of warfarin
  • clinically significant anemia (Hct \< 36% in men, \< 33% in women)
  • intestinal or stomach disease
  • inability to use right or left arm for endothelial function testing for any reason such as breast surgery, trauma, radiation to right axilla, lymphedema, right arm shunt, severe vascular disease in right arm
  • subjects on a disease specific diet
  • subjects on a weight control diet
  • subjects on a vegan diet
  • allergy to any kind of nut, including walnuts and peanuts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • DAVID L KATZ, MD

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

October 1, 2007

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)