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

Not Applicable

Completed

• Conditions: Cardiovascular Disease Risk; Type 2 Diabetes Risk
• Interventions: Other: Pecan-containing diet; Other: Nut-free diet

• Registration Number: NCT01950806
• Lead Sponsor: Tufts University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-25
• Study Start: 2014-01
• Primary Completion: 2016-08
• Study Completion: 2016-11
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pecan-containing diet	Pecan-containing diet	Test diet containing 1.5 oz pecans/2000 kcal/day for 28 days
Nut-free diet	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

Primary Outcome Measures

Name	Time	Method
Change in biomarkers of oxidative stress compared with control diet	Baseline and 4 weeks
Change in biomarkers of inflammation compared with control diet	Baseline and 4 weeks.
Change in biomarkers of endothelial function compared with control diet	Baseline and 4 weeks.
Change in biomarkers of antioxidant activity compared with control diet	Baseline and 4 weeks
Change in biomarkers of insulin resistance compared with control diet	Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure compared with control diet	Baseline and 4 weeks
Change in plasma lipid profile compared with control diet	Baseline and 4 weeks.

Trial Locations

Locations (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University; 🇺🇸 Boston, Massachusetts, United States