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

NCT02227511 | Completed

• 1 other identifier: 2014/170-31
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

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.

Outcome Measures

Primary Outcomes (1)

• amount of fat in the liver by magnetic resonance imaging

  exact measurement of fat in the liver by liver spectroscopy

  two months

Secondary Outcomes (1)

• cardiovascular risk factors

  two months

Study Arms (2)

fruit

ACTIVE COMPARATOR

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

Dietary Supplement: Fruits

nuts

ACTIVE COMPARATOR

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

Dietary Supplement: Nuts

Interventions

Fruits DIETARY_SUPPLEMENT

Randomization to extra fruit or nuts as snacks

fruit

Nuts DIETARY_SUPPLEMENT

Also known as: Randomization to extra fruit or nuts as snacks

nuts

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy subjects

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Fredrik H Nystrom

Linköping, 58185, Sweden

Location

Related Publications (1)

• 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.

  PMID: 26788923 DERIVED

MeSH Terms

Conditions

Fatty Liver; Insulin Resistance

Interventions

Fruit; Nuts; Snacks

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Meals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Head of Internal Medicine

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 28, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

SE (1)