Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults

NCT03485989 | Completed

• 1 other identifier: 6988
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Nutrition Poor; Micronutrient Deficiency; Aging

Keywords

hazelnuts; vitamin E; aging

Outcome Measures

Primary Outcomes (3)

• Changes in Plasma Micronutrient Levels

  Plasma levels of magnesium and vitamin E (alpha and gamma tocopherol) at baseline and 16 weeks after hazelnut intervention will be determined. Vitamin E analyses will be performed as absolute concentrations and concentrations corrected for total plasma lipids.

  Between baseline (Visit 2) and 16 weeks (last visit)

• Changes in Plasma Urine Vitamin E Metabolites

  Urine concentrations of alpha and gamma carboxyethyl hydroxychroman (metabolites of alpha and gamma tocopherol, respectively) will be determined at baseline and 16 weeks after hazelnut intervention. Urine values will be corrected for creatinine levels.

  Between baseline (Visit 2) and 16 weeks (last visit)

• Changes in Lymphocyte Proliferation Assay

  Blood samples will be collected and sent to Spectracell Labs, Inc. for a functional micronutrient analysis utilizing their proprietary lymphocyte proliferation assay. Micronutrient levels in these white blood cell samples will be assessed by changes in lymphocyte proliferation in the absence of a given vitamin or mineral, suggesting functional inadequacies that may not correspond to plasma values. Data will be represented as percent difference in cell proliferative capacity in cells growing in a complete media vs. a single-nutrient deprived media.

  Between baseline (Visit 2) and 16 weeks (last visit)

Secondary Outcomes (5)

• Lipid Status

  Between baseline (Visit 2) and 16 weeks (last visit)

• Glucose Homeostasis

  Between baseline (Visit 2) and 16 weeks (last visit)

• BMI

  Between baseline (Visit 2) and 16 weeks (last visit)

• Blood Pressure

  Between baseline (Visit 2) and 16 weeks (last visit)

• Heart Rate

  Between baseline (Visit 2) and 16 weeks (last visit)

Study Arms (1)

Hazelnuts

EXPERIMENTAL

Participants given 2 ounces (\~57 grams) of dry roasted hazelnuts to consume each day.

Other: Hazelnuts

Interventions

Hazelnuts OTHER

Dry roasted, individually packaged hazelnuts provided from the Hazelnuts Marketing Board of Oregon

Hazelnuts

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Oregon State University: lead
• Hazelnut Marketing Board: collaborator

Study Sites (1)

Linus Pauling Science Center

Corvallis, Oregon, 97331, United States

Location

Related Publications (1)

• Michels AJ, Leonard SW, Uesugi SL, Bobe G, Frei B, Traber MG. Daily Consumption of Oregon Hazelnuts Affects alpha-Tocopherol Status in Healthy Older Adults: A Pre-Post Intervention Study. J Nutr. 2018 Dec 1;148(12):1924-1930. doi: 10.1093/jn/nxy210.

  PMID: 30517727 RESULT

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Maret G Traber, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: April 3, 2018
• Study Start: June 22, 2016
• Primary Completion: September 18, 2017
• Study Completion: December 29, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)