The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes

April 24, 2017 updated by: Tufts University

The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes: A Controlled Feeding Trial in Overweight/Obese Adults With Central Adiposity

The objective of this randomized, controlled feeding study is to investigate the potential health benefits of a pecan-containing diet. The investigators hypothesize the chronic consumption of pecans will improve an array of biomarkers related to cardiovascular disease and type 2 diabetes risk, including indices of oxidative stress, antioxidant activity, inflammation, endothelial function, and insulin resistance when compared with a control diet that is absent nuts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men & postmenopausal women, age 50 years and over
  • BMI 25-35 kg/m2
  • Waist/hip >0.8 for women and >0.9 for men
  • Blood pressure between 120/80 and 159/99

Exclusion Criteria:

  • Cigarette smoking and/or nicotine replacement use
  • Individuals taking estrogen
  • Use of cholesterol-lowering medications
  • Use of blood pressure-lowering medications
  • Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications (prescription or over-the-counter [OTC])
  • Cardiovascular (heart) disease
  • Gastrointestinal disease
  • Kidney disease
  • Endocrine disease: including diabetes, unstable thyroid disease
  • Autoimmune disease: including rheumatoid arthritis, gout, lupus, HIV
  • Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
  • Systolic blood pressure > 159 mmHg and/or diastolic blood pressure > 99 mmHg
  • Regular use of oral or injectable steroids
  • Gain or loss of > 10% of body weight within previous 3 months; unwillingness to maintain your weight
  • Regular daily intake of ≥ 2 alcoholic drinks
  • Vegetarians
  • Current allergy to any kind of nut
  • Dietary supplement use, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pecan-containing diet
Test diet containing 1.5 oz pecans/2000 kcal/day for 28 days
Other: Pecan-containing diet
Other Names:
  • Isocaloric diet containing 1.5 oz pecans per 2000 kcal per day for 28 days
Placebo Comparator: Nut-free diet
Placebo diet containing no nuts or nut products, and identical in total fat and fiber as the test diet, for 28 days
Other: Nut-free diet
Other Names:
  • Isocaloric diet absent nuts and matched for total fat and fiber for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in biomarkers of oxidative stress compared with control diet
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in biomarkers of inflammation compared with control diet
Time Frame: Baseline and 4 weeks.
Baseline and 4 weeks.
Change in biomarkers of endothelial function compared with control diet
Time Frame: Baseline and 4 weeks.
Baseline and 4 weeks.
Change in biomarkers of antioxidant activity compared with control diet
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in biomarkers of insulin resistance compared with control diet
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in blood pressure compared with control diet
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in plasma lipid profile compared with control diet
Time Frame: Baseline and 4 weeks.
Baseline and 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University

Collaborators

National Pecan Shellers Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB10998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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