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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01692990
Other study ID # LL-spec1
Secondary ID
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


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
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