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Completed

NCT Number: NCT02227511

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

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.

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Key information

Conditions

Healthy Subjects Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fredrik H Nystrom

Linköping, 58185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects

Exclusion criteria

  • significant diseases that can affect outcomes, mental disorders that can affect participation.

Treatment and study plan

Fruits

Dietary Supplement

Randomization to extra fruit or nuts as snacks

Nuts

Dietary Supplement

Other names: Randomization to extra fruit or nuts as snacks

Primary outcomes

  1. amount of fat in the liver by magnetic resonance imaging

    Time frame: two months

    exact measurement of fat in the liver by liver spectroscopy

Secondary outcomes

  1. cardiovascular risk factors

    Time frame: two months

    Collection of markers for cardiovascular risk including glucose, insulin, lipoproteins etc. Analyses will be performed from blood samples.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2014
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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