Cardiovascular HealthPhase 1NCT01235390
Effects of the Consumption of California Walnuts on Cardiovascular Health
A Phase 1 study testing Walnuts in people with Cardiovascular Health and Immune Function, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of the 4-week consumption of California walnuts on vascular function and immune health in postmenopausal women of ages 50-70. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health, Immune Function
- What is being tested?
- Walnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2012
- Phase
- Phase 1
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 to 70 years of age
- Lack of menses in the last year and FSH 23-116.3 mlU/mL
- Subject is willing and able to comply with the study protocols.
- Subject is willing to consume California walnuts daily for four weeks.
- BMI 18.5-34.9 kg/m2
- Weight ≥ 110 pounds
Who cannot join
- BMI ≥ 35 kg/m2
- Self reported use of anticoagulation agents including NSAIDs
- Self reported use of oral cortisone or other immunosuppressive agents,
- Self reported underlying neoplasia or immunological disease,
- Dislike of walnuts
- Food faddists or those taking a non-traditional diet
Show all 27Show fewer
- Self reported physical activity restricted or reduced due to chronic health conditions
- Self reported diabetes
- Blood pressure ≥ 160/90 mm Hg
- PFA-100 readings 10 % outside of normal reference range (normal reference range for ADP-Collagen: 71-118 sec; Epinephrine-Collagen: 94-193 sec).
- Self reported renal or liver disease
- Self reported heart disease, which includes cardiovascular events and Stroke
- Self reported Cushing's syndrome
- Self reported chronic/routine high intensity exercise
- Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT
- Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by Dr. M. Eric Gershwin.
- Self reported cancer within past 5 years
- Self reported history of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year.
- Self reported use of MAOI inhibitor within the last 1 year (e.g. phenelzine (Nardil), tranylcypromine (Parnate), etc)
- Self reported malabsorption
- Self reported anxiety medications
- Self reported routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, hypertensive medications, such as ACE-inhibitors and beta-blockers.
- Asthma (can be worsened by mild to moderate food allergies).
- Indications of substance or alcohol abuse within the last 3 years
- Use of multi-vitamin and mineral other than a general formula of vitamins and minerals that meet the RDA
- Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months, and unwilling to discontinue use while participating in the study.
- Self reported nut allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Effects of California Walnuts on Vascular Function and Immune Health in Postmenopausal Women
The purpose of this study is to determine the effects of the 4-week consumption of California walnuts on vascular function and immune health in postmenopausal women of ages 50-70.
Primary outcome measures:
- vascular endothelial function
- platelet reactivity
- indoleamine 2, 3-deoxygenase (IDO)
Secondary outcome measures:
- relationship of walnut intake to lipoprotein, fatty acids and oxylipins
Read the detailed description
Cardiovascular disease is the leading cause of morbidity and mortality in the United States. The initiation and progression of atherosclerotic vascular disease is multifactoral in nature, and includes endothelial dysfunction, triggered by chronic inflammation. The consumption of foods rich in flavonoids and other phytochemicals has been inversely associated with cardiovascular disease risk in several epidemiological studies.
Aging is physiologically associated with a variable decline in several features of the immune function. In fact, immunosenescence, or aging of the immune system, is characterized by a reduced ability to fight infection and mount an adequate immune response once a novel infection is introduced. Both the innate and acquired immune systems can be affected with immune specific cells, cell signaling, cytokine production, and cell surface marker expression being all subject to age-related changes. The immune system cells within the digestive tract are an accessible and ideal target to stimulate immunity and diet-based nutritional interventions represent a non-invasive, relatively low-cost, and effective method of stimulating the immune function thus ultimately improving the antibody production in subjects at risk for immunosenescence. This is also based on the significant and dynamic interaction between luminal nutrients and the overall immune function. The study of nutritional influences on the immune system represents an area of growing interest to nutritionists, food scientists and immunologists. In general terms, dietary components have the potential to be an accessible and effective immune stimulant given the antigen presenting capacity of the intestine.
Due to their age and menopausal status, postmenopausal women are at a greater risk population for developing CVD. Males tend to show greater rates of CVD than pre-menopausal women, while women following menopause show an increase in CVD development. This increase in CVD for postmenopausal women is associated with endothelial dysfunction that becomes worse with age.
Recent studies have reported that consumption of walnuts is associated with beneficial effects in prevention of chronic diseases, such as cardiovascular disease (CVD), by favorably altering human serum profiles (i.e. decrease in LDL cholesterol and triglycerides and increase in HDL cholesterol and apolipoprotein A1). It has been shown that the consumption of walnuts, which mainly contain α-linolenic acid (ALA), L-arginine, and polyphenols, can beneficially alter vascular function and reduce inflammatory biomarkers. For example, Dr. Ros and his colleagues demonstrated that the addition of walnuts to a high-fat meal could improve endothelial function. This favorable influence on vasoactivity has been attributed to the antioxidant and anti-inflammatory properties of certain biofactors found in the walnuts.
In this study, we will focus on defining the potential role of California walnuts and its effects on vascular health and immune function. We will determine whether short term (4 week) consumption of California walnuts, particularly rich in ALA, L-arginine and polyphenols will improve endothelial function, platelet reactivity and immune function in an at-risk population of postmenopausal women 55-70 years of age.
- Conditions
- Cardiovascular Health, Immune Function
- Being tested
- Walnuts
- Keywords
- Postmenopausal women, walnuts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalnutsDietary supplement
The consumption of assigned walnuts once a day during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 5 g of walnuts | Experimental | Not described Receives: Dietary Supplement: Walnuts |
| 40 g of walnuts | Experimental | Not described Receives: Dietary Supplement: Walnuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Endothelial function is assessed by using peripheral arterial tonometry (PAT).
Measured: 0 and 4 hours, 4 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Sponsor
- Investigators
- Robert M Hackman, Ph. D, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235390
- Sponsor's protocol ID
- 200917609-1
- Status last verified
- Nov 2013
- First submitted
- 28 Oct 2010
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of California Walnuts on Vascular Function and Immune Health in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01235390
- Acronym / sponsor ID
- 200917609-1
- Conditions
- Cardiovascular Health, Immune Function
- Keywords
- Postmenopausal women, walnuts
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Nov 2010 (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 purpose of this study is to determine the effects of the 4-week consumption of California walnuts on vascular function and immune health in postmenopausal women of ages 50-70.
Primary outcome measures:
- vascular endothelial function
- platelet reactivity
- indoleamine 2, 3-deoxygenase (IDO)
Secondary outcome measures:
- relationship of walnut intake to lipoprotein, fatty acids and oxylipins
Detailed description
Cardiovascular disease is the leading cause of morbidity and mortality in the United States. The initiation and progression of atherosclerotic vascular disease is multifactoral in nature, and includes endothelial dysfunction, triggered by chronic inflammation. The consumption of foods rich in flavonoids and other phytochemicals has been inversely associated with cardiovascular disease risk in several epidemiological studies.
Aging is physiologically associated with a variable decline in several features of the immune function. In fact, immunosenescence, or aging of the immune system, is characterized by a reduced ability to fight infection and mount an adequate immune response once a novel infection is introduced. Both the innate and acquired immune systems can be affected with immune specific cells, cell signaling, cytokine production, and cell surface marker expression being all subject to age-related changes. The immune system cells within the digestive tract are an accessible and ideal target to stimulate immunity and diet-based nutritional interventions represent a non-invasive, relatively low-cost, and effective method of stimulating the immune function thus ultimately improving the antibody production in subjects at risk for immunosenescence. This is also based on the significant and dynamic interaction between luminal nutrients and the overall immune function. The study of nutritional influences on the immune system represents an area of growing interest to nutritionists, food scientists and immunologists. In general terms, dietary components have the potential to be an accessible and effective immune stimulant given the antigen presenting capacity of the intestine.
Due to their age and menopausal status, postmenopausal women are at a greater risk population for developing CVD. Males tend to show greater rates of CVD than pre-menopausal women, while women following menopause show an increase in CVD development. This increase in CVD for postmenopausal women is associated with endothelial dysfunction that becomes worse with age.
Recent studies have reported that consumption of walnuts is associated with beneficial effects in prevention of chronic diseases, such as cardiovascular disease (CVD), by favorably altering human serum profiles (i.e. decrease in LDL cholesterol and triglycerides and increase in HDL cholesterol and apolipoprotein A1). It has been shown that the consumption of walnuts, which mainly contain α-linolenic acid (ALA), L-arginine, and polyphenols, can beneficially alter vascular function and reduce inflammatory biomarkers. For example, Dr. Ros and his colleagues demonstrated that the addition of walnuts to a high-fat meal could improve endothelial function. This favorable influence on vasoactivity has been attributed to the antioxidant and anti-inflammatory properties of certain biofactors found in the walnuts.
In this study, we will focus on defining the potential role of California walnuts and its effects on vascular health and immune function. We will determine whether short term (4 week) consumption of California walnuts, particularly rich in ALA, L-arginine and polyphenols will improve endothelial function, platelet reactivity and immune function in an at-risk population of postmenopausal women 55-70 years of age.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 g of walnuts | Experimental | Dietary Supplement: Walnuts |
| 40 g of walnuts | Experimental | Dietary Supplement: Walnuts |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 to 70 years of age
- Lack of menses in the last year and FSH 23-116.3 mlU/mL
- Subject is willing and able to comply with the study protocols.
- Subject is willing to consume California walnuts daily for four weeks.
- BMI 18.5-34.9 kg/m2
Key exclusion criteria (27 listed)
- BMI ≥ 35 kg/m2
- Self reported use of anticoagulation agents including NSAIDs
- Self reported use of oral cortisone or other immunosuppressive agents,
- Self reported underlying neoplasia or immunological disease,
- Dislike of walnuts
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 |
|---|---|---|
| WalnutsThe consumption of assigned walnuts once a day during 4 weeks | Dietary supplement | 40 g of walnuts, 5 g of walnuts |
Primary outcome
Endothelial function
Time frame: 0 and 4 hours, 4 weeks after
Endothelial function is assessed by using peripheral arterial tonometry (PAT).
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 4 Nov 2013.
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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.
Robert M Hackman, Ph. D principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Walnuts in people with Cardiovascular Health and Immune Function, run by University of California, Davis 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 6 inclusion and 27 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 4 Nov 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Endothelial function (time frame: 0 and 4 hours, 4 weeks after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2013.