NCT01413646

Brief Summary

The purpose of this study is to examine the effects of walnut consumption on endothelial function and lipid markers in overweight patients with at least one factor of metabolic syndrome as compared to the control group.

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 2010

Shorter than P25 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, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

July 11, 2011

Last Update Submit

July 31, 2019

Conditions

Metabolic Syndrome

Keywords

obesitywalnutsendothelial function

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Brachial artery flow mediated dilation (FMD)

    8 weeks

Secondary Outcomes (6)

  • Weight

    8 weeks

  • Waist circumference

    8 weeks

  • Fasting lipid panel

    8 weeks

  • Fasting blood glucose

    8 weeks

  • Fasting insulin

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Walnut Supplementation

EXPERIMENTAL

Eight weeks with walnut supplementation to an ad lib diet

Dietary Supplement: Walnut Supplementation

2

PLACEBO COMPARATOR

Eight weeks ad lib diet without walnut supplementation

Dietary Supplement: No walnut supplementation

Interventions

Walnut SupplementationDIETARY_SUPPLEMENT

Eight weeks of walnut supplementation

Walnut Supplementation
No walnut supplementationDIETARY_SUPPLEMENT

Eight weeks without walnut supplementation

2

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female age 25-75 years
  • Non-smoker
  • Overweight (BMI ≥ 25) with central adiposity as indicated by waist circumference (102 cm. in men / 88 cm. in women)
  • Meet one risk factor of the metabolic syndrome.
  • blood pressure \> 130/85 or taking antihypertensive medication
  • fasting plasma glucose (FPG) \>100 mg/dL (6.1 mmol/L)
  • fasting serum triglycerides level (TG) \> 150 mg/dL (1.69 mmol/L)
  • fasting high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1.04 mmol/L)in men, and \< 50 mg/dL (1.29 mmol/L) in women.

You may not qualify if:

  • Anticipated inability to complete or comply with study protocol
  • Use of lipid-lowering or antihypertensive medications or aspirin unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning
  • Preexisting cardiovascular disease (including symptomatic coronary artery disease (CAD), myocardial infarction, angina pectoris, anginal equivalent, peripheral vascular disease, congestive heart failure, carotid stenosis)
  • Severe hypertension (systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg), even if well-controlled by medication.
  • Diagnosed diabetes mellitus
  • Regular use of multivitamins, Vitamin C, Vitamin E, fish oil, flax seed oil, omega-3 fatty acids, CoQ10, fiber supplements, garlic pills, arginine, red yeast rice, and any kind of antioxidant and unwillingness to discontinue supplementation for at least 4 weeks prior to study initiation and for study duration
  • Allergic to walnuts or any other nuts
  • Diagnosed eating disorder
  • On any specific diet, weight control diet, vegan diet
  • Any rheumatologic disease requiring regular use of NSAIDs or alternative medications
  • Regular use of fiber supplements
  • Regular use of vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), and anticoagulant drugs (including Coumadin, plavix )
  • Diagnosed sleep apnea
  • Substance abuse (chronic alcoholism, other chemical dependency)
  • Any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Related Publications (1)

  • Katz DL, Davidhi A, Ma Y, Kavak Y, Bifulco L, Njike VY. Effects of walnuts on endothelial function in overweight adults with visceral obesity: a randomized, controlled, crossover trial. J Am Coll Nutr. 2012 Dec;31(6):415-23. doi: 10.1080/07315724.2012.10720468.

    PMID: 23756586DERIVED

MeSH Terms

Conditions

Metabolic SyndromeObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David L. Katz, MD, MPH

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRINCIPAL INVESTIGATOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

August 10, 2011

Study Start

February 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

August 2, 2019

Record last verified: 2019-07

Locations

US(1)