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

Healthy Clinical Trial

Official title:

Title in Norwegian: Ung og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Barn.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02025933
• Other study ID #: 2013/541
• Status: Terminated
• Phase: N/A
• First received: December 17, 2013
• Last updated: May 22, 2016
• Start date: August 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• overweight (iso-BMI > 25)

• 9-12 years

• healthy

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Salmon Group
The children are advised to eat at least 75g of salmon per serving, but no more than 150g
• Cod Group
The children are advised to eat at least 75g of cod per serving, but no more than 150g
• Meat Group
The children are advised to eat at least 75g of meat per serving, but no more than 150g

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Fiskeri- og Havbruksnæringens Forskningsfond

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Body composition		Baseline and end of intervention (12 weeks)	No