Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults



Status:Completed
Conditions:Food Studies, Healthy Studies
Therapuetic Areas:Pharmacology / Toxicology, Other
Healthy:No
Age Range:55 - Any
Updated:4/17/2018
Start Date:June 22, 2016
End Date:December 29, 2017

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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).

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, liver disease, and cancer. Older adults are increasingly more
susceptible to vitamin and mineral deficiencies with changes in dietary preferences, changes
in socioeconomic status, decreased consumption of a variety of foods, poor absorption in the
gut, and an increased demand for many of these micronutrients with advanced age.

Epidemiological studies and recent clinical trials have shown that use of
multivitamin/mineral or single nutrient supplements, such as vitamin E, have beneficial
effects on disease risk, but many people are hesitant to use dietary supplements due to
reports of ineffectiveness or potential negative effects. However, food sources of vitamin E
and other key vitamins and minerals continue to show health benefits. As an alternative to
mandating consumption of multivitamin and mineral supplements or food fortification, a
dietary solution is to increase consumption of nutrient-dense foods, like hazelnuts.

Tree nuts, including hazelnuts, contain a wide variety of vitamins and minerals, and are
particularly good source of vitamin E and magnesium, two "shortfall nutrients" that are
lacking in the typical American diet. Over 90% of U.S. adults do not meet recommended intake
levels of vitamin E, and 60% do not get enough magnesium. Tree nuts are also a good source of
protein and fiber and are high in healthful unsaturated fatty acids and phytochemicals such
as flavonoids and phytosterols.

Most clinical studies on the benefits of nut consumption have been conducted using almonds
and walnuts, with hazelnuts used less frequently. However, the health benefits of consuming
hazelnuts have been demonstrated in many clinical trials, including lower blood glucose
levels, alterations in blood lipids, and declines in biomarkers of oxidative stress. Although
several clinical trials have investigated nutritional impact of hazelnuts in adults, no
clinical trials with hazelnuts have focused on examining micronutrient status and potential
health benefits only in older (≥55 years) adults.

Determination of body status of many micronutrients can be difficult, especially so the
evaluation of vitamin E levels when age is considered as a factor. Although serum
α-tocopherol levels are generally higher in adults above the age of 50 compared to younger
adults, the increased prevalence of hypercholesterolemia in older adults makes interpretation
of circulating α-tocopherol levels difficult. Alternatively, urinary α- and γ-carboxyethyl
hydroxychromanol (α- and γ-CEHC) is believed to be a biomarker of α- and γ-tocopherol status
that changes with vitamin E intake. In particular, low α-CEHC excretion is considered a
reliable marker of poor α-tocopherol status, while an increase in α-CEHC is indicative of
adequate α-tocopherol status.

The objective of this study was to determine whether daily hazelnut consumption by healthy
older adults for 16 weeks improves biomarkers of micronutrient status, especially vitamin E
and magnesium. For a detailed assessment of vitamin E status, plasma α- and γ-tocopherol
concentrations were determined together with urinary α- and γ-CEHC levels. In addition, a
commercially available lymphocyte proliferation assay was utilized to evaluate the status of
several other micronutrients. Since hazelnut consumption is reported to reduce blood lipids
and improve glucose homeostasis, these biomarkers were also monitored in our study.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
2900 Southwest Campus Way
Corvallis, Oregon 97331
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from
Corvallis, OR
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