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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Fruits; Dietary supplement: Nuts

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • Fredrik H Nystrom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy subjects

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fruit; Participants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals	Dietary supplement: Fruits; Randomization to extra fruit or nuts as snacks
Active Comparator: nuts; Participants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals	Dietary supplement: Nuts; Other Names: Randomization to extra fruit or nuts as snacks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of fat in the liver by magnetic resonance imaging	exact measurement of fat in the liver by liver spectroscopy	two months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping

Publications and helpful links

General Publications

• 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. Erratum In: PLoS One. 2018 Dec 13;13(12):e0209450.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: fruit, nuts, liver fat, insulin, glucose; Focus of the study is to compare the often given advice to eat fruit, containing large amount of glucose and fructose, with nuts that are more rich in fat.
• Other Study ID Numbers: 2014/170-31