Effects of a Single Dose of Brazil Nuts on Blood Lipids

NCT ID: NCT05537324

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2018-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Cholesterol Level, High

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brazil nut

50g Brazil nuts

Group Type EXPERIMENTAL

Brazil nut

Intervention Type OTHER

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

Coconut

46g Coconut flakes

Group Type OTHER

Coconut

Intervention Type OTHER

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

Interventions

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Brazil nut

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

Intervention Type OTHER

Coconut

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Skogli Health and Rehabilitation Center

OTHER

Sponsor Role lead

Responsible Party

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Allan Fjelmberg

Medical director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allan Fjelmberg, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Skogli Health and Rehabilitation Center

Locations

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Skogli Health and Rehabilitation Center

Lillehammer, Innlandet, Norway

Site Status

Countries

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Norway

Other Identifiers

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Skonøtt

Identifier Type: -

Identifier Source: org_study_id

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