Effects of a Single Dose of Brazil Nuts on Blood Lipids

Sponsor

Skogli Health and Rehabilitation Center (Other)

Overall Status

Completed

CT.gov ID

NCT05537324

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cholesterol Level, High	Other: Brazil nut Other: Coconut	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 groupThis 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)

Primary Purpose:

Treatment

Official Title:

Effects of a Single Dose of Brazil Nuts on Blood Lipids. A Randomised Controlled Trial.

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Brazil nut

50g Brazil nuts

Other: Brazil nut

Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 50g Brazil nuts

Other: Coconut

46g Coconut flakes

Other: Coconut

Blood lipids are measured at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of 46g coconut flakes

Outcome Measures

Primary Outcome Measures

Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skogli Health and Rehabilitation Center	Lillehammer	Innlandet	Norway	2614

Sponsors and Collaborators

Skogli Health and Rehabilitation Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allan Fjelmberg, Medical director, Skogli Health and Rehabilitation Center

ClinicalTrials.gov Identifier:

NCT05537324

Other Study ID Numbers:

Skonøtt

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Allan Fjelmberg, Medical director, Skogli Health and Rehabilitation Center

Blood lipids, Brazil nut, coconut

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Sep 13, 2022