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Completed

NCT Number: NCT01950806

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

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.

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Key information

Conditions

Cardiovascular Disease Risk Type 2 Diabetes Risk

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pecan-containing diet

Other

Other names: Isocaloric diet containing 1.5 oz pecans per 2000 kcal per day for 28 days

Nut-free diet

Other

Other names: Isocaloric diet absent nuts and matched for total fat and fiber for 28 days.

Primary outcomes

  1. Change in biomarkers of oxidative stress compared with control diet

    Time frame: Baseline and 4 weeks

  2. Change in biomarkers of inflammation compared with control diet

    Time frame: Baseline and 4 weeks.

  3. Change in biomarkers of endothelial function compared with control diet

    Time frame: Baseline and 4 weeks.

  4. Change in biomarkers of antioxidant activity compared with control diet

    Time frame: Baseline and 4 weeks

  5. Change in biomarkers of insulin resistance compared with control diet

    Time frame: Baseline and 4 weeks

Secondary outcomes

  1. Change in blood pressure compared with control diet

    Time frame: Baseline and 4 weeks

  2. Change in plasma lipid profile compared with control diet

    Time frame: Baseline and 4 weeks.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Pecan Shellers Association

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2013
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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