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Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children (STOPP-8 OM3)

Primary Purpose

Lifestyle-related Condition, Overweight and Obesity, Essential Fatty Acid Deficiency

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Omega-3
Placebo
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lifestyle-related Condition focused on measuring Omega-3, physical activity, children, obesity, sedentary, accelerometry, BMI, fatty acids, inflammatory markers, intervention, randomized, double blind

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children in second grade of Swedish primary school willing to participate

Sites / Locations

  • Karolinska Universitetssjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega-3 supplementation

Placebo

Arm Description

50 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition.

50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention.

Outcomes

Primary Outcome Measures

Total physical activity
The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer.
Body mass
The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.

Secondary Outcome Measures

BMI
The childrens' height will be measured using standardised stadiometer at 0 and 15 weeks. Along with the bosy mass data individual BMI (kilograms/meters squared) will be calculated for each time point.
Cardiovascular risk markers
Blood samples is collected from all participants at 0 and 15 weeks. This will not be decisive for inclusion in the study. Local anaesthesia will be used and the children can choose not to leave blood. Fasting blood samples will be analyzed for LDL-C, HDL-C, tot-C, TG, hsCRP, TNF-α, IL-6, IL-1, PAI-1, Glucose, Insulin, fatty acids and FTO-gene expression.
Childrens reported quality of life
A validated questionnaire for self-report of subjective perception of quality of life are filled out by each child at 0 and 15 weeks with assistance of an adult (parent or caregiver).
Perceived motor skill
A validated questionnaire for subjective self-report of motor skills are filled out by each child at 0 and 15 weeks with assistance of an adult (parent or caregiver).
Self reported physical activity
A validated questionnaire for subjective self-report of physical activity will be filled out by each child at 0 and 15 weeks with assistance by parent or caregiver.

Full Information

First Posted
March 24, 2011
Last Updated
October 3, 2018
Sponsor
Karolinska Institutet
Collaborators
Midsona AB, Forskningsrådet för arbetsliv och socialvetenskap, FAS
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1. Study Identification

Unique Protocol Identification Number
NCT01323283
Brief Title
Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children
Acronym
STOPP-8 OM3
Official Title
Intervention Study of the Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects of Omega-3 Fatty Acids in 8 Year Old Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Midsona AB, Forskningsrådet för arbetsliv och socialvetenskap, FAS

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study hypothesizes that supplementation of omega-3 fatty acids (OM3) can increase physical activity, inhibit rapid gain in body weight and BMI in both sedentary and normally active 8 year old children. The purpose is secondarily to explore patterns of associations between OM3 supplementation, baseline and follow-up levels in all studied parameters. The study also aims to study if basal levels of OM3 are correlated with physical activity and to study if there is an association between basal levels of OM3 and the effect of OM3 supplementation on physical activity. To study if there is an effect of OM3 supplementation on triglyceride and LDL cholesterol levels and to study if there are more pronounced effects on children with higher levels. To study if OM3 supplementation, compared with placebo reduce weight increase among children at risk to become overweight. To study if there is an association between effects of OM3 on physical activity, weight and risk markers in blood. To study if there are any gender differences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle-related Condition, Overweight and Obesity, Essential Fatty Acid Deficiency
Keywords
Omega-3, physical activity, children, obesity, sedentary, accelerometry, BMI, fatty acids, inflammatory markers, intervention, randomized, double blind

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 supplementation
Arm Type
Active Comparator
Arm Description
50 % of all included children will be randomized to this arm and administered capsules containing an omega-3 fatty acid composition.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
50 % of included children will be randomized to this arm and will be administered placebo capsules for the 15 week intervention.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Other Intervention Name(s)
OM3
Intervention Description
This group will receive capsules containing omega-3, omega-6 and vitamin E. The dosage is six capsules per day containing a total of 558 mg of eico-pentaenoic acid (EPA), 174 mg of docosahexaeonic acid (DHA), 60 mg of gamma-linolenic acid (GLA) and 9,6 mg vitamin E in natural form (alfa-tocopherol), gelatine, glycerol. Participants will be instructed to eat three capsules each morning and evening.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.
Primary Outcome Measure Information:
Title
Total physical activity
Description
The childrens' physical activity will be monitored during 7 consequtive days at 0 and 15 weeks with tri-axial accelerometer.
Time Frame
15 weeks
Title
Body mass
Description
The childrens' body mass will be measured with standardized scales at 0 and 15 weeks.
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
BMI
Description
The childrens' height will be measured using standardised stadiometer at 0 and 15 weeks. Along with the bosy mass data individual BMI (kilograms/meters squared) will be calculated for each time point.
Time Frame
15 weeks
Title
Cardiovascular risk markers
Description
Blood samples is collected from all participants at 0 and 15 weeks. This will not be decisive for inclusion in the study. Local anaesthesia will be used and the children can choose not to leave blood. Fasting blood samples will be analyzed for LDL-C, HDL-C, tot-C, TG, hsCRP, TNF-α, IL-6, IL-1, PAI-1, Glucose, Insulin, fatty acids and FTO-gene expression.
Time Frame
15 weeks
Title
Childrens reported quality of life
Description
A validated questionnaire for self-report of subjective perception of quality of life are filled out by each child at 0 and 15 weeks with assistance of an adult (parent or caregiver).
Time Frame
15 weeks
Title
Perceived motor skill
Description
A validated questionnaire for subjective self-report of motor skills are filled out by each child at 0 and 15 weeks with assistance of an adult (parent or caregiver).
Time Frame
15 weeks
Title
Self reported physical activity
Description
A validated questionnaire for subjective self-report of physical activity will be filled out by each child at 0 and 15 weeks with assistance by parent or caregiver.
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children in second grade of Swedish primary school willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Marcus, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Universitetssjukhuset
City
Huddinge
State/Province
Södermanland
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Study of Omega-3 Fatty Acids Regarding Ergogenic, Anti-inflammatory and Obesity Inhibitory Effects in 8 Year Old Children

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