Study on the Effect of Fish Oil and Appetite

Obesity Clinical Trial

Official title:

Study on the Effect of Fish Oil and Appetite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692990
• Other study ID #: LL-spec1
• Status: Completed
• Phase: Phase 0
• First received: May 14, 2012
• Last updated: November 9, 2012
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

20 normal-weight healthy subjects (10 males, 10 females) were in two periods given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they were given a standard breakfast and asked to report their appetite on visual analogue scales (VAS) immediately before and after the meal. The results were analyzed in accordance with the paired design under consideration of both supplement sequence and gender.

Description:

In a randomized cross-over design, 20 normal-weight healthy subjects (10 males, 10 females) were given 10 of 0.5-mL capsules/day of fish oil and soybean oil for 3 weeks. In the end of each period they were given a standard breakfast and asked to report their appetite on visual analogue scales (VAS) immediately before and after the meal. The results were analyzed in accordance with the paired design under consideration of both supplement sequence and gender.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Normal weight (18.5<BMI<25 kg/m2).

• Healthy.

Exclusion Criteria:

• Subjects taking medication that could influence appetite.

• Subjects with special nutritional needs e.g. pregnant and lactating, seriously ill or old people.

• Subjects that had had fish oil-supplements for four weeks prior to the intervention period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cachexia
• Obesity

Intervention

Dietary Supplement:
• Fish oil
For 3 weeks 5 g/d in 10 capsules, providing 3.5 g long-chain n-3 fatty acids in the fish oil period. Cross-over between arms with 1 week of wash out

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
AAstrup

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appetite and satiation	Appetite and satiation were measured by visual analogue scales (VAS), which assessed satiation, hunger, fullness and desire to eat. Each scale was 100 mm in length with words anchored at each end, expressing the most positive and negative rating of each category.	October 7th - November 25th 2011	No
Secondary	Weight change	Body weight was measured on the same scale without shoes and wearing light clothing in the morning before breakfast.	October 7th - November 25th 2011	No