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

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ClinicalTrials.gov Identifier: NCT02227511
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Fredrik H Nystrom, 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Dietary Supplement: Fruits Dietary Supplement: Nuts Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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 Name: Randomization to extra fruit or nuts as snacks




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227511


Locations
Sweden
Fredrik H Nystrom
Linköping, Sweden, 58185
Sponsors and Collaborators
University Hospital, Linkoeping

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fredrik H Nystrom, Professor, MD, Head of Internal Medicine, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT02227511     History of Changes
Other Study ID Numbers: 2014/170-31
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

Keywords provided by Fredrik H Nystrom, University Hospital, Linkoeping:
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.