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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950806
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
National Pecan Shellers Association
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Risk Type 2 Diabetes Risk Other: Pecan-containing diet Other: Nut-free diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950806


Locations
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United States, Massachusetts
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
National Pecan Shellers Association

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT01950806    
Other Study ID Numbers: IRB10998
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases