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CompletedNCT01950806Updated Apr 25, 2017

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

An interventional study of Pecan-containing diet and Nut-free diet in Cardiovascular Disease Risk and Type 2 Diabetes Risk, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-25.

Sponsored by Tufts University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Disease Risk
  • Type 2 Diabetes Risk
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 28 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Active comparator
    Pecan-containing diet

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

    Other: Pecan-containing diet

  • 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

Interventions

  • OtherPecan-containing diet

    Also known as: Isocaloric diet containing 1.5 oz pecans per 2000 kcal per day for 28 days

  • OtherNut-free diet

    Also known as: Isocaloric diet absent nuts and matched for total fat and fiber for 28 days.

06

What researchers measure

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.

07

Study locations

1 site
  • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
    Boston, Massachusetts 02111, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01950806
Lead sponsor
Tufts University
Collaborators
National Pecan Shellers Association
Responsible party
Sponsor
First posted
Sep 25, 2013
Start date
Jan 2014
Primary completion
Aug 2016
Completion
Nov 2016
Last update
Apr 25, 2017
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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