Effects of a Single Dose of Brazil Nuts on Blood Lipids

September 11, 2022 updated by: Allan Fjelmberg, Skogli Health and Rehabilitation Center

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Innlandet
      • Lillehammer, Innlandet, Norway, 2614
        • Skogli Health and Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brazil nut
50g Brazil nuts
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 50g Brazil nuts
Other: Coconut
46g Coconut flakes
Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 46g coconut flakes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Blood tests are measured at baseline, 3 hours, 6 hours, 24 hours, 7 days and 14 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Allan Fjelmberg, MD, MPH, Skogli Health and Rehabilitation Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

September 11, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 11, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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