Status:
COMPLETED
Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults
Lead Sponsor:
Oregon State University
Collaborating Sponsors:
Hazelnut Marketing Board
Conditions:
Nutrition Poor
Micronutrient Deficiency
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
With advancing age, older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons. Nutrient-dense food sources of vitamin E and other key vitamins and minerals, like hazeln...
Detailed Description
Older adults are at increased risk of various chronic diseases where inadequate levels of vitamins and minerals may play a significant role, including cardiovascular disease, Alzheimer's disease, live...
Eligibility Criteria
Inclusion
- Must be generally healthy
- Women must be post-menopausal (12 months period-free) or surgically sterile.
- Must be willing to eat two ounces (56 g) of dry roasted hazelnuts each day during the study
- Must refrain from taking nutritional supplements during the study
- Must follow a diet that excludes all nuts (other than those supplied), seeds, and other vitamin E-rich foods (see Restricted Foods and Supplements document)
- Must be willing to complete food frequency questionnaires
- Must be willing to give blood samples on 3 separate occasions and urine on 2 separate occasions
Exclusion
- Current or past (two years) use of any tobacco (including e-cigarettes) and marijuana products
- Allergy to any nut including tree nuts and peanuts, or hazelnut pollen
- History of asthma
- Vitamin E supplement use during the last three months or regular use of vitamin E-enriched nutritional drinks (e.g. Ensure)
- Regular nut eaters: individuals that regularly consume \> 3.5 ounces (112 g) of almonds, hazelnuts and/or sunflower seeds per week in any form (e.g. nuts, nut butters, nut oil, etc.), and no more than 10 mg alpha-tocopherol (vitamin E) per day from their diet.
- Bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), or serious chronic illness including Crohn's disease, celiac disease, diverticulitis, chronic diarrhea, ulcerative colitis, gastritis
- History of cardiovascular disease including stroke, heart attack, or congestive heart failure
- Any history of arterial bypass or stent placement.
- History of emphysema or chronic obstructive pulmonary disease (COPD)
- Stage II hypertension (either systolic pressure \> 159 mm Hg or diastolic pressure 99 mm Hg)
- History of cancer during the previous 5 years
- Diabetes (type 1 or type 2) or use of drugs to lower blood sugar or increase insulin production or sensitivity
- Use of medications to lower cholesterol other than statins
- Use of medications to decrease fat or cholesterol absorption
- Unwillingness to refrain from taking dietary supplements (except calcium and vitamin D and vitamin B12), magnesium-containing drugs such as certain antacids, stool softeners and laxatives
- BMI \< 18.5 or \> 35
- Blood chemistry limits; any of the following at screening excludes participation:
- Fasting blood glucose ≥ 126 mg/dL
- LDL cholesterol ≥160 mg/dL
- Triglyceride ≥200 mg/dL
- High-sensitivity C-reactive protein (hsCRP) \> 10 mg/L
Key Trial Info
Start Date :
June 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03485989
Start Date
June 22 2016
End Date
December 29 2017
Last Update
August 28 2019
Active Locations (1)
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1
Linus Pauling Science Center
Corvallis, Oregon, United States, 97331