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

NCT ID: NCT01950806

Last Updated: 2017-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease Risk Type 2 Diabetes Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pecan-containing diet

Test diet containing 1.5 oz pecans/2000 kcal/day for 28 days

Group Type ACTIVE_COMPARATOR

Pecan-containing diet

Intervention Type OTHER

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

Group Type PLACEBO_COMPARATOR

Nut-free diet

Intervention Type OTHER

Interventions

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Pecan-containing diet

Intervention Type OTHER

Nut-free diet

Intervention Type OTHER

Other Intervention Names

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Isocaloric diet containing 1.5 oz pecans per 2000 kcal per day for 28 days Isocaloric diet absent nuts and matched for total fat and fiber for 28 days.

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Pecan Shellers Association

UNKNOWN

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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IRB10998

Identifier Type: -

Identifier Source: org_study_id

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