Cardiovascular Disease Risk, Type 2 Diabetes Risk
Conditions
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.
Interventions
OTHERPecan-containing diet
OTHERNut-free diet
Sponsors
National Pecan Shellers Association
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in biomarkers of oxidative stress compared with control diet | Baseline and 4 weeks |
| Change in biomarkers of endothelial function compared with control diet | Baseline and 4 weeks. |
| Change in biomarkers of antioxidant activity compared with control diet | Baseline and 4 weeks |
| Change in biomarkers of insulin resistance compared with control diet | Baseline and 4 weeks |
| Change in biomarkers of inflammation compared with control diet | Baseline and 4 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Change in plasma lipid profile compared with control diet | Baseline and 4 weeks. |
| Change in blood pressure compared with control diet | Baseline and 4 weeks |
Countries
United States
Outcome results
None listed