Effects of a Single Dose of Brazil Nuts on Blood Lipids
1 other identifier
interventional
52
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
September 13, 2022
CompletedSeptember 13, 2022
September 1, 2022
2.2 years
August 4, 2022
September 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Blood tests are measured at baseline, 3 hours, 6 hours, 24 hours, 7 days and 14 days after intervention
Study Arms (2)
Brazil nut
EXPERIMENTAL50g Brazil nuts
Coconut
OTHER46g Coconut flakes
Interventions
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 50g Brazil nuts
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 46g coconut flakes
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Skogli Health and Rehabilitation Center
Lillehammer, Innlandet, 2614, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan Fjelmberg, MD, MPH
Skogli Health and Rehabilitation Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical director
Study Record Dates
First Submitted
August 4, 2022
First Posted
September 13, 2022
Study Start
April 1, 2016
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
September 13, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share