Cholesterol Level, HighNCT05537324
Effects of a Single Dose of Brazil Nuts on Blood Lipids
A study testing Brazil nut and Coconut in people with Cholesterol Level, High, run by Skogli Health and Rehabilitation Center at 1 site in Norway.
Trial summary
Several studies have shown that regular intake of nuts may improve blood lipids. However, few studies have investigated the effects on blood lipids after a single intake of nuts. The present study was conducted in order to evaluate the acute effects of a single intake of Brazil nuts on blood lipids. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholesterol Level, High
- What is being tested?
- Brazil nut and Coconut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2016to 1 Jul 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who participated in a rehabilitation program over three weeks at a rehabilitation center. Participants were at the rehabilitation center due to rheumatic diseases or chronic pain conditions / fibromyalgia.
Who cannot join
- Food allergy, lactose intolerance, celiac disease, mild illness for the last 3 weeks (infections or inflammatory conditions), serious illness (eg. heart attack) or undergone surgery during the previous 3 months, intake of Brazil four weeks prior study enrollment, using cholesterol-lowering or blood-thinning drugs, planning to eat more than one meal in other places than the rehabilitation center during the study.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Skogli Health and Rehabilitation Center
Lillehammer, Innlandet, 2614
About this study
Official title: Effects of a Single Dose of Brazil Nuts on Blood Lipids. A Randomised Controlled Trial.
Several studies have shown that regular intake of nuts may improve blood lipids. However, few studies have investigated the effects on blood lipids after a single intake of nuts. The present study was conducted in order to evaluate the acute effects of a single intake of Brazil nuts on blood lipids.
The study was a non-blinded randomized controlled study with 52 participants, 26 participants in both the Brazil nut group and in the control group. Blood tests were taken at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of either 50g Brazil nuts or an isocaloric amount of coconut flakes. We then conducted an unpaired t-test in order to compare changes in blood lipids between the two groups. P-values < 0.05 were considered statistically significant
- Conditions
- Cholesterol Level, High
- Being tested
- Brazil nut, Coconut
- Keywords
- Blood lipids, Brazil nut, coconut
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazil nutOther
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 50g Brazil nuts
CoconutOther
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 46g coconut flakes
| Study group | Role | What they receive |
|---|---|---|
| Brazil nut | Experimental | 50g Brazil nuts Receives: Other: Brazil nut |
| Coconut | Other | 46g Coconut flakes Receives: Other: Coconut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l)
Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l) between the experimental group and the control group at specific times after intervention
Measured: Blood tests are measured at baseline, 3 hours, 6 hours, 24 hours, 7 days and 14 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Apr 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol Level, HighStudies 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
- Model description
- This study was a non-blinded randomized controlled trial, where participants were requited and enrolled to the study / intervention continuously over about two years. Half of the participants (26) in the experimental group and half of the participants in the control group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skogli Health and Rehabilitation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Fjelmberg, Skogli Health and Rehabilitation Center
- Investigators
- Allan Fjelmberg, MD, MPH, Principal investigator, Skogli Health and Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537324
- Sponsor's protocol ID
- Skonøtt
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Dose of Brazil Nuts on Blood Lipids. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05537324
- Acronym / sponsor ID
- Skonøtt
- Conditions
- Cholesterol Level, High
- Keywords
- Blood lipids, Brazil nut, coconut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Skogli Health and Rehabilitation CenterUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 13 Sep 2022 (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.
Several studies have shown that regular intake of nuts may improve blood lipids. However, few studies have investigated the effects on blood lipids after a single intake of nuts. The present study was conducted in order to evaluate the acute effects of a single intake of Brazil nuts on blood lipids.
The study was a non-blinded randomized controlled study with 52 participants, 26 participants in both the Brazil nut group and in the control group. Blood tests were taken at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of either 50g Brazil nuts or an isocaloric amount of coconut flakes. We then conducted an unpaired t-test in order to compare changes in blood lipids between the two groups. P-values < 0.05 were considered statistically significant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a non-blinded randomized controlled trial, where participants were requited and enrolled to the study / intervention continuously over about two years. Half of the participants (26) in the experimental group and half of the participants in the control group
| Arm | Type | Receives |
|---|---|---|
| Brazil nut | Experimental | Other: Brazil nut50g Brazil nuts |
| Coconut | Other | Other: Coconut46g Coconut flakes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who participated in a rehabilitation program over three weeks at a rehabilitation center. Participants were at the rehabilitation center due to rheumatic diseases or chronic pain conditions / fibromyalgia.
Key exclusion criteria (1 listed)
- Food allergy, lactose intolerance, celiac disease, mild illness for the last 3 weeks (infections or inflammatory conditions), serious illness (eg. heart attack) or undergone surgery during the previous 3 months, intake of Brazil four weeks prior study enrollment, using cholesterol-lowering or blood-thinning drugs, planning to eat more than one meal in other places than the rehabilitation center during the study.
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 |
|---|---|---|
| Brazil nutBlood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 50g Brazil nuts | Other | Brazil nut |
| CoconutBlood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 46g coconut flakes | Other | Coconut |
Primary outcome
Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l)
Time frame: Blood tests are measured at baseline, 3 hours, 6 hours, 24 hours, 7 days and 14 days after intervention
Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l) between the experimental group and the control group at specific times after intervention
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 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Allan Fjelmberg, MD, MPH principal investigator
Skogli Health and Rehabilitation 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 Brazil nut and Coconut in people with Cholesterol Level, High, run by Skogli Health and Rehabilitation Center at 1 site in Norway.
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 1 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 13 Sep 2022. 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 Norway. 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?
Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l) (time frame: Blood tests are measured at baseline, 3 hours, 6 hours, 24 hours, 7 days and 14 days after intervention). 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 13 Sep 2022.