- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692990
Study on the Effect of Fish Oil and Appetite
November 9, 2012 updated by: AAstrup
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Frederiksberg, Denmark, 1958
- Department of Human Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fish oil
5 g/d in 10 capsules, providing 3.5 g of long-chain n-3 fatty acids
|
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
|
Placebo Comparator: Soy bean oil
5 g/d in 10 capsules
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite and satiation
Time Frame: October 7th - November 25th 2011
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight change
Time Frame: October 7th - November 25th 2011
|
Body weight was measured on the same scale without shoes and wearing light clothing in the morning before breakfast.
|
October 7th - November 25th 2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lotte Lauritzen, PhD, Department of Human Nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
May 14, 2012
First Submitted That Met QC Criteria
September 25, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Estimate)
November 12, 2012
Last Update Submitted That Met QC Criteria
November 9, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LL-spec1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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