Back to resultsEffects of a Single Dose of Brazil Nuts on Blood Lipids
Primary Purpose
Cholesterol Level, High
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Brazil nut
Coconut
Sponsored by
About this trial
This is an interventional treatment trial for Cholesterol Level, High focused on measuring Blood lipids, Brazil nut, coconut
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Skogli Health and Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Brazil nut
Coconut
Arm Description
50g Brazil nuts
46g Coconut flakes
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05537324
First Posted
August 4, 2022
Last Updated
September 11, 2022
Sponsor
Skogli Health and Rehabilitation Center
1. Study Identification
Unique Protocol Identification Number
NCT05537324
Brief Title
Effects of a Single Dose of Brazil Nuts on Blood Lipids
Official Title
Effects of a Single Dose of Brazil Nuts on Blood Lipids. A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skogli Health and Rehabilitation Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholesterol Level, High
Keywords
Blood lipids, Brazil nut, coconut
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brazil nut
Arm Type
Experimental
Arm Description
50g Brazil nuts
Arm Title
Coconut
Arm Type
Other
Arm Description
46g Coconut flakes
Intervention Type
Other
Intervention Name(s)
Brazil nut
Intervention Description
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 50g Brazil nuts
Intervention Type
Other
Intervention Name(s)
Coconut
Intervention Description
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 46g coconut flakes
Primary Outcome Measure Information:
Title
Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l)
Description
Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l) between the experimental group and the control group at specific times after intervention
Time Frame
Blood tests are measured at baseline, 3 hours, 6 hours, 24 hours, 7 days and 14 days after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Fjelmberg, MD, MPH
Organizational Affiliation
Skogli Health and Rehabilitation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skogli Health and Rehabilitation Center
City
Lillehammer
State/Province
Innlandet
ZIP/Postal Code
2614
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Single Dose of Brazil Nuts on Blood Lipids
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