Project Healthy Eating in Children. A Study on the Health Effects of Fish Intake in Overweight Children

NCT02025933 | Terminated

• 1 other identifier: 2013/541
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

It has previously been seen that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improve metabolic health in children aged 9-12 years as well when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in children as measured by glucose tolerance, lipid metabolism and inflammatory markers.

Conditions

Healthy

Keywords

Children; Age 9-12 years; Overweight (iso-BMI > 25)

Outcome Measures

Primary Outcomes (1)

• Changes in metabolic status (glucose, lipids, inflammation)

  We will investigate any changes in the metabolic status by analyzing parameters affected by changes in glucose homeostasis, lipid metabolism and inflammation.

  Baseline and end of intervention period (12 weeks)

Secondary Outcomes (1)

• Body composition

  Baseline and end of intervention (12 weeks)

Study Arms (3)

Salmon Group

Participants will eat 75 - 150 grams of salmon for dinner, three times a week for 12 weeks.

Other: Salmon Group

Cod Group

Participants will eat 75-150 grams of cod for dinner, three times a week for 12 weeks.

Other: Cod Group

Meat Group

Participants will eat 75-150 grams of mixed meat for dinner, three times a week for 12 weeks.

Other: Meat Group

Interventions

Salmon Group OTHER

The children are advised to eat at least 75g of salmon per serving, but no more than 150g

Salmon Group

Cod Group OTHER

The children are advised to eat at least 75g of cod per serving, but no more than 150g

Cod Group

Meat Group OTHER

The children are advised to eat at least 75g of meat per serving, but no more than 150g

Meat Group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Cildren aged 9-12 years are invited to participate in the study. The children must be healthy and not use prescription medications that affects lipid metabolism, glucose regulation or the immunesystem.

You may qualify if:

• overweight (iso-BMI \> 25)
• years
• healthy

You may not qualify if:

• diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis
• prescription medications affecting the metabolism of glucose, lipids or the immune system
• use of supplements containing long chain n-3 fatty acids
• high intake of fish
• food allergy

Sponsors & Collaborators

• University of Bergen: lead
• The Fisheries and Aquaculture Industry Research Fund: collaborator

Study Sites (1)

University of Bergen

Bergen, 5021, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for DNA analysis

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oddrun A Gudbrandsen, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: January 1, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

NO (1)