Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults

Completed · Not applicable

Conditions studied: Nutrition Poor, Micronutrient Deficiency, Aging

In brief

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 hazelnuts, may offer a simple means of improving nutritional status of healthy older adults. This hypothesis is that individuals eating hazelnuts everyday will result in measurable increases in magnesium and vitamin E levels, two under-consumed micronutrients among older adults. Thus, subjects will consume two ounces (56 g) of hazelnuts each day for sixteen weeks. Investigators will measure vitamin E and magnesium levels along with a general assessment of micronutrient status as primary outcomes. Since nuts are nutrient-rich sources of unsaturated fatty acids but low in carbohydrates, changes in fasting glucose, lipid and lipoprotein profiles, and BMI will also be determined (secondary outcomes).

Key facts

Study ID

NCT03485989

Run by

Oregon State University

People needed

41

Starts

2016-06-22

Expected to finish

2017-12-29

Last updated by the study team

2019-08-28

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Linus Pauling Science Center — Corvallis, Oregon, United States

Full record on ClinicalTrials.gov

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