Clinical trial NCT01950806: The Effect of Pecans on Biomarkers of Risk for Cardiovascular Disease and Diabetes
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease Risk
Type 2 Diabetes Risk
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Pecan Shellers Association
First posted: 2013-09-25
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change in biomarkers of oxidative stress compared with control diet
timeFrame: Baseline and 4 weeks
measure: Change in biomarkers of inflammation compared with control diet
timeFrame: Baseline and 4 weeks.
measure: Change in biomarkers of endothelial function compared with control diet
timeFrame: Baseline and 4 weeks.
measure: Change in biomarkers of antioxidant activity compared with control diet
timeFrame: Baseline and 4 weeks
measure: Change in biomarkers of insulin resistance compared with control diet
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in blood pressure compared with control diet
timeFrame: Baseline and 4 weeks
measure: Change in plasma lipid profile compared with control diet
timeFrame: Baseline and 4 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
References: