Lipid Metabolism DisordersWALDINCT02329067
The Metabolic Effect of Walnuts in Healthy Subjects
A study testing walnuts in people with Lipid Metabolism Disorders, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism Disorders
- What is being tested?
- walnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Jul 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal healthy women and healthy men
- Age >50 yrs
- Written informed consent prior to study participation
Who cannot join
- Known allergy to nuts
- Evidence of alcohol (women >70g/week, men >140g/week), tabacco or drug abuse
- Obesity ≥35 kg/m2
- Diabetes mellitus
- Hypertension >140/90 mmHg or history of hypertension
- LDL-cholesterol >190 mg/dl, Triglycerides > 350 mg/dl
Show all 14Show fewer
- History of atherosclerotic disease
- Liver disease of any etiology
- Kidney disease of any etiology (GFR < 60 ml/min/1.73)
- Uncontrolled thyroid disease or other endocrine diseases
- Acute or chronic inflammatory diseases
- Active malignancy
- Current or previous (within 3 months) treatment with antidiabetic drugs, hypolipidemic drugs, antihypertensive drugs, anti-inflammatory drugs, vitamin E, hormonal replacement therapy
- major surgical intervention within 3 months (or planned)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Metabolic Effect of Walnut Consumption in Healthy Men and Healthy Postmenopausal Women Substituting Walnuts for Different Food Components
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
Read the detailed description
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
The metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. We want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. In a third group we will test what food is omitted if no specific instructions are given. Furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- walnuts
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walnutsOther
consumption of 43 g walnuts per day
| Study group | Role | What they receive |
|---|---|---|
| walnut-CH | Experimental | Western type diet including walnuts (43g/day); Walnuts substitute carbohydrates Receives: Other: walnuts |
| Walnut-SFA | Experimental | Western type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids Receives: Other: walnuts |
| Walnut-LIB | Experimental | Western type diet including walnuts (43g/day); no specific recommendation Receives: Other: walnuts |
| Control | No intervention | Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-HDL-cholesterol
Measured: 8 weeks
Secondary outcomes (9)
LDL-cholesterol
Measured: 8 weeks
total-cholesterol
Measured: 8 weeks
apoB
Measured: 8 weeks
triglycerides
Measured: 8 weeks
fasting glucose
Measured: 8 weeks
HOMA index
Measured: 8 weeks
caloric intake
Measured: 8 weeks
ratio CH:fat:protein
Measured: 8 weeks
ratio SFA:MUFA:PUFA
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 posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies 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
- 180 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
- Investigators
- Klaus G Parhofer, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329067
- Sponsor's protocol ID
- WALNUT-2
- Acronym
- WALDI
- Status last verified
- Aug 2017
- First submitted
- 29 Dec 2014
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. 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 Substituting Walnuts for Different Food Components
- ClinicalTrials.gov ID
- NCT02329067
- Acronym / sponsor ID
- WALDI / WALNUT-2
- Conditions
- Lipid Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 31 Dec 2014 (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 whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
Detailed description
The objectives of the proposed study are to assess whether the metabolic effects of walnut consumption depends on which food components the walnuts substitute (i.e. carbohydrates; saturated fatty acids) and whether it is important to consume walnuts as snacks or with meals.
The metabolic effects of walnut consumption may not only relate to the ingested walnuts but also to what is not eaten when walnuts are consumed. We want to evaluate whether the metabolic changes are more pronounced if study participants are instructed to reduce carbohydrates or saturated fatty acids to remain on an isocaloric diet. In a third group we will test what food is omitted if no specific instructions are given. Furthermore half of the subjects in each group will be instructed to eat walnuts with meals and half as snacks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| walnut-CH | Experimental | Other: walnutsWestern type diet including walnuts (43g/day); Walnuts substitute carbohydrates |
| Walnut-SFA | Experimental | Other: walnutsWestern type diet including walnuts (43g/day); Walnuts substitute saturated fatty acids |
| Walnut-LIB | Experimental | Other: walnutsWestern type diet including walnuts (43g/day); no specific recommendation |
| Control | No intervention | –Isocaloric western type diet w/o nuts, nut butters or nut oils of any kind |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal healthy women and healthy men
- Age >50 yrs
- Written informed consent prior to study participation
Key exclusion criteria (14 listed)
- Known allergy to nuts
- Evidence of alcohol (women >70g/week, men >140g/week), tabacco or drug abuse
- Obesity ≥35 kg/m2
- Diabetes mellitus
- Hypertension >140/90 mmHg or history of hypertension
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 |
|---|---|---|
| walnutsconsumption of 43 g walnuts per day | Other | Walnut-LIB, Walnut-SFA, walnut-CH |
Primary outcome
Non-HDL-cholesterol
Time frame: 8 weeks
9 secondary outcomes
LDL-cholesterol
Time frame: 8 weeks
total-cholesterol
Time frame: 8 weeks
apoB
Time frame: 8 weeks
triglycerides
Time frame: 8 weeks
fasting glucose
Time frame: 8 weeks
HOMA index
Time frame: 8 weeks
caloric intake
Time frame: 8 weeks
ratio CH:fat:protein
Time frame: 8 weeks
ratio SFA:MUFA:PUFA
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 29 Aug 2017.
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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.
Klaus G Parhofer, MD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walnuts in people with Lipid Metabolism Disorders, 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 3 inclusion and 14 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 29 Aug 2017. 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?
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 29 Aug 2017.