HealthyNCT00626691
The Effects of Walnuts on Antioxidant Capacity and Nutritional Status in Humans
A study testing Walnut consumption in people with Healthy, run by Tufts University at 1 site in United States.
Trial summary
The goal of this study is to find out if the daily consumption of English walnuts (Juglans regia L.) for 6 wk, at a dose readily incorporated into the diet (0.75 or 1.50 oz), will have a positive effect on antioxidant capacity and nutrient status in a population of healthy adults, aged 50-70 y. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Walnut consumption
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2007
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy men and postmenopausal women age 50 or over
- BMI 18.5-35 kg/m2
Who cannot join
- Cigarette smoking and/or nicotine replacement use
- History or known allergy to nuts of any kind
- Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
- Individuals taking estrogen
- Use of cholesterol-lowering medications
- Gastrointestinal disease
Show all 18Show fewer
- Kidney disease
- Endocrine disease: including diabetes, untreated thyroid disease
- Rheumatoid arthritis
- Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
- Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg
- Regular use of oral steroids
- Regular daily intake of ≥ 2 alcoholic drinks
- Illicit drug use
- No fish oil supplements (including cod liver oil) for 6 weeks prior to study admission
- No high dose (≥ 3X RDA) supplements of vitamins C, E, selenium, or beta-carotene for one month prior to study admission
- No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission
- No regular consumption of pomegranate juice (≥ 180 mL or 6 oz/d, ≥ 3 times/wk) for one month prior to study admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
The goal of this study is to find out if the daily consumption of English walnuts (Juglans regia L.) for 6 wk, at a dose readily incorporated into the diet (0.75 or 1.50 oz), will have a positive effect on antioxidant capacity and nutrient status in a population of healthy adults, aged 50-70 y.
Read the detailed description
Epidemiological studies conducted in large populations have consistently shown that increased consumption of plant-based, antioxidant-rich foods, i.e., fruits, vegetables, grains, and nuts, reduces the risk for several chronic diseases. Among the various plants consumed worldwide, English walnuts (Juglans regia L.) have been reported to have the highest antioxidant activity, second only to rosehips (Rosa canina L.). There are a number of different compounds present in walnuts that are known to exhibit antioxidant activity, including vitamin E (as γ-tocopherol), melatonin, and several non-flavonoid polyphenols (e.g., ellagic acid monomers and polymeric ellagitannins). In vitro and ex vivo, studies have demonstrated the ability of walnuts and walnut extracts to increase the resistance of low density lipoprotein (LDL) to oxidation. Walnuts and/or their constituents have also been shown to decrease levels of oxidative stress in diabetic mice and increase serum antioxidant capacity in rats2. In humans, in vivo antioxidant capacity changes after consuming walnuts have only been measured in subjects with Type 2 diabetes. The antioxidant capacity of the lipophilic compartments, as well as the cooperative/synergistic interactions between the water- and fat-soluble antioxidants present in plasma after walnut consumption have not been measured. Indeed, there have been no studies conducted to date of the effect of walnut consumption on the total antioxidant capacity of healthy men and women. The goal of our proposed study is to determine if consuming walnuts in amounts readily incorporated into the diet can affect the antioxidant capacity of older adults.
- Conditions
- Healthy
- Being tested
- Walnut consumption
- Keywords
- antioxidant, walnut, nutritional status, Antioxidant capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut consumptionBehavioural
Subjects will be randomized to receive either 0.75 oz (22.5 g) or 1.5 oz (45 g) of walnuts daily for the first 6 wk period, followed by a 6 wk washout period, and an additional 6 wk period during which they will receive the reverse dose of walnuts daily. Each serving of walnuts will be pre-weighed and pre-packaged.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status and antioxidant capacity
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2007
- Primary completionDec 2007
- Study completionDec 2007
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 HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission, Tufts Medical Center
- Investigators
- Diane L McKay, PhD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626691
- Sponsor's protocol ID
- PV2707
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2008
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McKay DL, Chen CY, Yeum KJ, Matthan NR, Lichtenstein AH, Blumberg JB. Chronic and acute effects of walnuts on antioxidant capacity and nutritional status in humans: a randomized, cross-over pilot study. Nutr J. 2010 May 12;9:21. doi: 10.1186/1475-2891-9-21.
PubMed 20462428
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Walnuts on Antioxidant Capacity and Nutritional Status in Humans
- ClinicalTrials.gov ID
- NCT00626691
- Acronym / sponsor ID
- PV2707
- Conditions
- Healthy
- Keywords
- antioxidant, walnut, nutritional status, Antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- California Walnut Commission, Tufts Medical Center
- Study start
- Feb 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Feb 2008 (estimated)
- 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.
The goal of this study is to find out if the daily consumption of English walnuts (Juglans regia L.) for 6 wk, at a dose readily incorporated into the diet (0.75 or 1.50 oz), will have a positive effect on antioxidant capacity and nutrient status in a population of healthy adults, aged 50-70 y.
Detailed description
Epidemiological studies conducted in large populations have consistently shown that increased consumption of plant-based, antioxidant-rich foods, i.e., fruits, vegetables, grains, and nuts, reduces the risk for several chronic diseases. Among the various plants consumed worldwide, English walnuts (Juglans regia L.) have been reported to have the highest antioxidant activity, second only to rosehips (Rosa canina L.). There are a number of different compounds present in walnuts that are known to exhibit antioxidant activity, including vitamin E (as γ-tocopherol), melatonin, and several non-flavonoid polyphenols (e.g., ellagic acid monomers and polymeric ellagitannins). In vitro and ex vivo, studies have demonstrated the ability of walnuts and walnut extracts to increase the resistance of low density lipoprotein (LDL) to oxidation. Walnuts and/or their constituents have also been shown to decrease levels of oxidative stress in diabetic mice and increase serum antioxidant capacity in rats2. In humans, in vivo antioxidant capacity changes after consuming walnuts have only been measured in subjects with Type 2 diabetes. The antioxidant capacity of the lipophilic compartments, as well as the cooperative/synergistic interactions between the water- and fat-soluble antioxidants present in plasma after walnut consumption have not been measured. Indeed, there have been no studies conducted to date of the effect of walnut consumption on the total antioxidant capacity of healthy men and women. The goal of our proposed study is to determine if consuming walnuts in amounts readily incorporated into the diet can affect the antioxidant capacity of older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generally healthy men and postmenopausal women age 50 or over
- BMI 18.5-35 kg/m2
Key exclusion criteria (18 listed)
- Cigarette smoking and/or nicotine replacement use
- History or known allergy to nuts of any kind
- Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
- Individuals taking estrogen
- Use of cholesterol-lowering medications
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 |
|---|---|---|
| Walnut consumptionSubjects will be randomized to receive either 0.75 oz (22.5 g) or 1.5 oz (45 g) of walnuts daily for the first 6 wk period, followed by a 6 wk washout period, and an additional 6 wk period during which they will receive the reverse dose of walnuts daily. Each serving of walnuts will be pre-weighed and pre-packaged. | Behavioural | – |
Primary outcome
Nutritional status and antioxidant capacity
Time frame: 5 months
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 19 Feb 2009.
- Derived from this study: PubMed 20462428McKay DL, Chen CY, Yeum KJ, Matthan NR, Lichtenstein AH, Blumberg JB. Chronic and acute effects of walnuts on antioxidant capacity and nutritional status in humans: a randomized, cross-over pilot study. Nutr J. 2010 May 12;9:21. doi: 10.1186/1475-2891-9-21.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Diane L McKay, PhD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut consumption in people with Healthy, run by Tufts 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 2 inclusion and 18 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 19 Feb 2009. 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?
Nutritional status and antioxidant capacity (time frame: 5 months). 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 NCT00626691, 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 19 Feb 2009.