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

Cardiovascular Disease Risk Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950806
• Other study ID #: IRB10998
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: April 24, 2017
• Start date: January 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease Risk
• Cardiovascular Diseases
• Diabetes Mellitus
• Type 2 Diabetes Risk

Intervention

Other:
• Pecan-containing diet

• Nut-free diet

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Pecan Shellers Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in biomarkers of oxidative stress compared with control diet		Baseline and 4 weeks
Primary	Change in biomarkers of inflammation compared with control diet		Baseline and 4 weeks.
Primary	Change in biomarkers of endothelial function compared with control diet		Baseline and 4 weeks.
Primary	Change in biomarkers of antioxidant activity compared with control diet		Baseline and 4 weeks
Primary	Change in biomarkers of insulin resistance compared with control diet		Baseline and 4 weeks
Secondary	Change in blood pressure compared with control diet		Baseline and 4 weeks
Secondary	Change in plasma lipid profile compared with control diet		Baseline and 4 weeks.