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Study on the Effect of Fish Oil and Appetite

Primary Purpose

Obesity, Cachexia

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Fish oil
Sponsored by
AAstrup
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Appetite, Fish oil, Long-chain n-3 fatty acids

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish oil

Soy bean oil

Arm Description

5 g/d in 10 capsules, providing 3.5 g of long-chain n-3 fatty acids

5 g/d in 10 capsules

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight change
Body weight was measured on the same scale without shoes and wearing light clothing in the morning before breakfast.

Full Information

First Posted
May 14, 2012
Last Updated
November 9, 2012
Sponsor
AAstrup
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1. Study Identification

Unique Protocol Identification Number
NCT01692990
Brief Title
Study on the Effect of Fish Oil and Appetite
Official Title
Study on the Effect of Fish Oil and Appetite
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
AAstrup

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cachexia
Keywords
Appetite, Fish oil, Long-chain n-3 fatty acids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Experimental
Arm Description
5 g/d in 10 capsules, providing 3.5 g of long-chain n-3 fatty acids
Arm Title
Soy bean oil
Arm Type
Placebo Comparator
Arm Description
5 g/d in 10 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Intervention Description
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
Primary Outcome Measure Information:
Title
Appetite and satiation
Description
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.
Time Frame
October 7th - November 25th 2011
Secondary Outcome Measure Information:
Title
Weight change
Description
Body weight was measured on the same scale without shoes and wearing light clothing in the morning before breakfast.
Time Frame
October 7th - November 25th 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Lauritzen, PhD
Organizational Affiliation
Department of Human Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

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Study on the Effect of Fish Oil and Appetite

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