HyperlipidemiasNCT03680027
Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects
A study testing Walnut-enriched Group in people with Hyperlipidemias, run by Eastern Mediterranean University.
Trial summary
Walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a well-controlled feeding trials. Current study have been determined the effects of daily walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic individuals. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Walnut-enriched Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2015to 30 Sep 2015
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperlipidemic patients who are not using any lipid lowering medications
- Non-smoker
- No alcohol consumption
- Individuals who are having ≤30kg/m2
- Individuals who do not have any allergy for nut consumption
- Female participants who are not pregnant or breastfeeding
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- Individuals should not be in a weight loss programme
- Having not consumed regular nuts for the last 1 month,
- Except hypertension, they should not have other chronic diseases (such as diabetes, chronic renal failure)
- No intense exercise
Who cannot join
- Failure to meet the criteria for inclusion criteria.
About this study
Official title: Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects: A Randomized-Controlled Trial: A Randomized-Controlled Trial
Walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a well-controlled feeding trials. Current study have been determined the effects of daily walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic individuals.
Read the detailed description
In this, randomized controlled trial, mild to moderate hyperlipidemic subjects were randomly divided into 2 groups as walnut-enriched (n=20) and control (n=17) groups for 6 weeks. All subjects adhered to a medical nutrition therapy as low-fat and low-cholesterol diet. The walnut-enriched group was supplemented with 40 g/day of walnuts added to their diets. In order to follow nutritional status of subjects, they were visited every 15 days (in total 4 times). Anthropometric measurements of the subjects were taken and were monitored at each visit during the study. Blood samples were measured at the beginning and again at the end of the study.
- Conditions
- Hyperlipidemias
- Being tested
- Walnut-enriched Group
- Keywords
- Serum lipids, Hyperlipidemia, Walnut
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut-enriched GroupDietary supplement
All subjects supplemented with 40 g/day of walnuts for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | In 'Control group' participants had 6 week follow-up without any intervention. |
| Interventional Group | Experimental | In 'Interventional group' participants had 6 week follow-up and during that period of time, they were asked to consume 40g/day walnut. Participants in intervention group was ensured to consume all 40g of walnut every day, during their snack times for 6 weeks. Receives: Dietary Supplement: Walnut-enriched Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in serum lipids and fasting glucose levels
In both group, participants have decreased serum total cholesterol and LDL-cholesterol.However especially walnut-enrcihed group significantly changed fasting glucose and insulin levels.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start10 Jul 2015
- Primary completion27 Aug 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Okburan, Eastern Mediterranean University
- Investigators
- Gözde Okburan, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680027
- Sponsor's protocol ID
- 2015/13-04
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects: A Randomized-Controlled Trial: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT03680027
- Acronym / sponsor ID
- 2015/13-04
- Conditions
- Hyperlipidemias
- Keywords
- Serum lipids, Hyperlipidemia, Walnut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 21 Sep 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.
Walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a well-controlled feeding trials. Current study have been determined the effects of daily walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic individuals.
Detailed description
In this, randomized controlled trial, mild to moderate hyperlipidemic subjects were randomly divided into 2 groups as walnut-enriched (n=20) and control (n=17) groups for 6 weeks. All subjects adhered to a medical nutrition therapy as low-fat and low-cholesterol diet. The walnut-enriched group was supplemented with 40 g/day of walnuts added to their diets. In order to follow nutritional status of subjects, they were visited every 15 days (in total 4 times). Anthropometric measurements of the subjects were taken and were monitored at each visit during the study. Blood samples were measured at the beginning and again at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –In 'Control group' participants had 6 week follow-up without any intervention. |
| Interventional Group | Experimental | Dietary Supplement: Walnut-enriched GroupIn 'Interventional group' participants had 6 week follow-up and during that period of time, they were asked to consume 40g/day walnut. Participants in intervention group was ensured to consume all 40g of walnut every day, during their snack times for 6 weeks. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Hyperlipidemic patients who are not using any lipid lowering medications
- Non-smoker
- No alcohol consumption
- Individuals who are having ≤30kg/m2
- Individuals who do not have any allergy for nut consumption
Key exclusion criteria (1 listed)
- Failure to meet the criteria for inclusion criteria.
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-enriched GroupAll subjects supplemented with 40 g/day of walnuts for 6 weeks. | Dietary supplement | Interventional Group |
Primary outcome
Reduction in serum lipids and fasting glucose levels
Time frame: Six weeks
In both group, participants have decreased serum total cholesterol and LDL-cholesterol.However especially walnut-enrcihed group significantly changed fasting glucose and insulin levels.
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 24 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Gözde Okburan principal investigator
Eastern Mediterranean University
Questions about this trial
What is this clinical trial studying?
A study testing Walnut-enriched Group in people with Hyperlipidemias, run by Eastern Mediterranean University.
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 10 inclusion and 1 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Reduction in serum lipids and fasting glucose levels (time frame: Six 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 24 Sep 2018.