Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects

NCT ID: NCT02227511

Last Updated: 2016-05-16

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-05-31

Brief Summary

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Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic rate, liver steatosis and physical activity are investigated ahead of start of the study and at the end of the trial period och two months. Participants will be allowed to buy fruits or nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed for the costs of the snacks.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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fruit

Participants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals

Group Type ACTIVE_COMPARATOR

Fruits

Intervention Type DIETARY_SUPPLEMENT

Randomization to extra fruit or nuts as snacks

nuts

Participants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals

Group Type ACTIVE_COMPARATOR

Nuts

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Fruits

Randomization to extra fruit or nuts as snacks

Intervention Type DIETARY_SUPPLEMENT

Nuts

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Randomization to extra fruit or nuts as snacks

Eligibility Criteria

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Inclusion Criteria

* healthy subjects

Exclusion Criteria

* significant diseases that can affect outcomes, mental disorders that can affect participation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Fredrik H Nystrom

Professor, MD, Head of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fredrik H Nystrom

Linköping, , Sweden

Site Status

Countries

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Sweden

References

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Agebratt C, Strom E, Romu T, Dahlqvist-Leinhard O, Borga M, Leandersson P, Nystrom FH. A Randomized Study of the Effects of Additional Fruit and Nuts Consumption on Hepatic Fat Content, Cardiovascular Risk Factors and Basal Metabolic Rate. PLoS One. 2016 Jan 20;11(1):e0147149. doi: 10.1371/journal.pone.0147149. eCollection 2016.

Reference Type DERIVED
PMID: 26788923 (View on PubMed)

Other Identifiers

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2014/170-31

Identifier Type: -

Identifier Source: org_study_id

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