NCT05537324

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

August 4, 2022

Last Update Submit

September 11, 2022

Conditions

Keywords

Blood lipids, Brazil nut, coconut

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

EXPERIMENTAL

50g Brazil nuts

Other: Brazil nut

Coconut

OTHER

46g Coconut flakes

Other: Coconut

Interventions

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

Brazil nut
CoconutOTHER

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

Coconut

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

2S albumin, brazil nut

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Allan Fjelmberg, MD, MPH

    Skogli Health and Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
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

Locations