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

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: Fruits; Dietary Supplement: Nuts

• Registration Number: NCT02227511
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-27
• Study First Posted: 2014-08-28
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• healthy subjects

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fruit	Fruits	Participants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals
nuts	Nuts	Participants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals

Primary Outcome Measures

Name	Time	Method
amount of fat in the liver by magnetic resonance imaging	two months	exact measurement of fat in the liver by liver spectroscopy

Secondary Outcome Measures

Name	Time	Method
cardiovascular risk factors	two months	Collection of markers for cardiovascular risk including glucose, insulin, lipoproteins etc. Analyses will be performed from blood samples.

Trial Locations

Locations (1)

Fredrik H Nystrom; 🇸🇪 Linköping, Sweden