HealthyNCT01188902
The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women
A study testing walnut in people with Healthy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The objectives of the proposed study are to assess the effect of walnut consumption on parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial function and blood pressure in healthy men and healthy postmenopausal women Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- walnut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Aug 2012
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal healthy women and healthy men
- Age > 50 yrs
Who cannot join
- Evidence of alcohol, tabacco or drug abuse
- Obesity ≥ 35 kg/m2
- Diabetes mellitus
- Hypertension
- LDL-cholesterol > 190 mg/dl, Triglycerides > 350 mg/dl
- History of atherosclerotic disease
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of the proposed study are to assess the effect of walnut consumption on parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial function and blood pressure in healthy men and healthy postmenopausal women
- Conditions
- Healthy
- Being tested
- walnut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walnutDietary supplement
walnut consumption 48 g/d
| Study group | Role | What they receive |
|---|---|---|
| walnut | Experimental | western type diet with 48 g walnut per day Receives: Dietary Supplement: walnut |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting non-HDL-cholesterol
Measured: 8 weeks
Secondary outcomes (12)
area under the triglyceride curve (AUC-TG)
area under the plasma triglyceride concentration curve following a standardized oral fat challenge
Measured: 8 weeks
incremental area under the triglyceride curve (iAUC-TG)
incremental area under the plasma triglyceride concentration curve following a standardized oral fat challenge
Measured: 8 weeks
LDL-cholesterol
fasting plasma LDL-cholesterol concentration
Measured: 8 weeks
HDL-cholesterol
fasting plasma HDL-cholesterol concentration
Measured: 8 weeks
triglyceride
fasting plasma triglyceride concentration
Measured: 8 weeks
glucose
fasting plasma glucose concentration
Measured: 8 weeks
HOMA
Measured: 8 weeks
insulin
Measured: 8 weeks
HbA1c
Measured: 8 weeks
area under the glucose curve (AUC-glucose)
area under the plasma glucose concentration curve following a standardized oral challenge
Measured: 8 weeks
area under the insulin curve (AUC-insulin)
area under the plasma insulin concentration curve following a standardized oral challenge
Measured: 8 weeks
endothelial function
Postprandial (mixed meal challenge) endothelial function (flow mediated dilatation, flow-independent dilatation)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Parhofer, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188902
- Sponsor's protocol ID
- Walnut-2010
- Status last verified
- Jan 2013
- First submitted
- 25 Aug 2010
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01188902
- Acronym / sponsor ID
- Walnut-2010
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Aug 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 objectives of the proposed study are to assess the effect of walnut consumption on parameters of lipid metabolism, glucose metabolism, incretins and adipokines, endothelial function and blood pressure in healthy men and healthy postmenopausal women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| walnut | Experimental | Dietary Supplement: walnutwestern type diet with 48 g walnut per day |
| control | No intervention | – |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal healthy women and healthy men
- Age > 50 yrs
Key exclusion criteria (6 listed)
- Evidence of alcohol, tabacco or drug abuse
- Obesity ≥ 35 kg/m2
- Diabetes mellitus
- Hypertension
- LDL-cholesterol > 190 mg/dl, Triglycerides > 350 mg/dl
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 |
|---|---|---|
| walnutwalnut consumption 48 g/d | Dietary supplement | walnut |
Primary outcome
Fasting non-HDL-cholesterol
Time frame: 8 weeks
12 secondary outcomes
area under the triglyceride curve (AUC-TG)
Time frame: 8 weeks
incremental area under the triglyceride curve (iAUC-TG)
Time frame: 8 weeks
LDL-cholesterol
Time frame: 8 weeks
HDL-cholesterol
Time frame: 8 weeks
triglyceride
Time frame: 8 weeks
glucose
Time frame: 8 weeks
HOMA
Time frame: 8 weeks
insulin
Time frame: 8 weeks
HbA1c
Time frame: 8 weeks
area under the glucose curve (AUC-glucose)
Time frame: 8 weeks
area under the insulin curve (AUC-insulin)
Time frame: 8 weeks
endothelial function
Time frame: 8 weeks
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 8 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Healthy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 6 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 8 Jan 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 Germany. 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?
Fasting non-HDL-cholesterol (time frame: 8 weeks). 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 8 Jan 2013.