Nutrition PoorNCT03485989
Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults
A study testing Hazelnuts in people with Nutrition Poor and Micronutrient Deficiency, run by Oregon State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Poor, Micronutrient Deficiency, Aging
- What is being tested?
- Hazelnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2016to 29 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Linus Pauling Science Center
Corvallis, Oregon, 97331
About this study
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).
Read the 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, 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.
- Conditions
- Nutrition Poor, Micronutrient Deficiency, Aging
- Being tested
- Hazelnuts
- Keywords
- hazelnuts, vitamin E, aging
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HazelnutsOther
Dry roasted, individually packaged hazelnuts provided from the Hazelnuts Marketing Board of Oregon
| Study group | Role | What they receive |
|---|---|---|
| Hazelnuts | Experimental | Participants given 2 ounces (~57 grams) of dry roasted hazelnuts to consume each day. Receives: Other: Hazelnuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Between baseline (Visit 2) and 16 weeks (last visit)
Secondary outcomes (5)
Lipid Status
Lipid profile will be determined from samples blood sent to a CLIA(Clinical Laboratory Improvement Amendments)-certified laboratory. Changes to fasting lipoprotein and triglyceride status determined before and after hazelnut intervention.
Measured: Between baseline (Visit 2) and 16 weeks (last visit)
Glucose Homeostasis
Glucose and insulin levels will be determined from blood samples to a CLIA-certified laboratory. Changes to fasting glucose levels and insulin levels determined before and after hazelnut intervention.
Measured: Between baseline (Visit 2) and 16 weeks (last visit)
BMI
Height and weight will be measured by stadiometer and scale. Changes to height and weight will be expressed as BMI calculated before and after hazelnut intervention.
Measured: Between baseline (Visit 2) and 16 weeks (last visit)
Blood Pressure
Changes to resting systolic and diastolic blood pressure (mmHg) will be measured by sphygmomanometer before and after hazelnut intervention.
Measured: Between baseline (Visit 2) and 16 weeks (last visit)
Heart Rate
Resting heart rate will be measured manually using the ventral aspect of radial artery.
Measured: Between baseline (Visit 2) and 16 weeks (last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start22 Jun 2016
- Primary completion18 Sep 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- Hazelnut Marketing Board
- Responsible party
- Principal investigator, Maret Traber, Oregon State University
- Investigators
- Maret G Traber, PhD, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485989
- Sponsor's protocol ID
- 6988
- Status last verified
- Aug 2019
- First submitted
- 13 Mar 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30517727
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults
- ClinicalTrials.gov ID
- NCT03485989
- Acronym / sponsor ID
- 6988
- Conditions
- Nutrition Poor, Micronutrient Deficiency, Aging
- Keywords
- hazelnuts, vitamin E, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- Hazelnut Marketing Board
- Study start
- 22 Jun 2016 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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, 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hazelnuts | Experimental | Other: HazelnutsParticipants given 2 ounces (~57 grams) of dry roasted hazelnuts to consume each day. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HazelnutsDry roasted, individually packaged hazelnuts provided from the Hazelnuts Marketing Board of Oregon | Other | Hazelnuts |
Primary outcome
Changes in Plasma Micronutrient Levels
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
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.
Changes in Plasma Urine Vitamin E Metabolites
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
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.
Changes in Lymphocyte Proliferation Assay
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
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.
5 secondary outcomes
Lipid Status
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
Glucose Homeostasis
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
BMI
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
Blood Pressure
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
Heart Rate
Time frame: Between baseline (Visit 2) and 16 weeks (last visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Results publication: PubMed 30517727Michels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maret G Traber, PhD principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hazelnuts in people with Nutrition Poor and Micronutrient Deficiency, run by Oregon State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Plasma Micronutrient Levels (time frame: Between baseline (Visit 2) and 16 weeks (last visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.