Study on the Effect of Fish Oil and Appetite

• ClinicalTrials.gov Identifier: NCT01692990
• Recruitment Status: Completed
• First Posted: September 26, 2012
• Last Update Posted: November 12, 2012
• Sponsor: AAstrup
• Information provided by (Responsible Party): AAstrup, University of Copenhagen

Tracking Information

• First Submitted Date: May 14, 2012
• First Posted Date: September 26, 2012
• Last Update Posted Date: November 12, 2012
• Study Start Date: October 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 25, 2012)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 25, 2012)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study on the Effect of Fish Oil and Appetite
• Official Title: Study on the Effect of Fish Oil and Appetite
• 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.
• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• Obesity
• Cachexia

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

Study Arms

• Experimental: Fish oil
  5 g/d in 10 capsules, providing 3.5 g of long-chain n-3 fatty acids
  Intervention: Dietary Supplement: Fish oil
• Placebo Comparator: Soy bean oil
  5 g/d in 10 capsules
  Intervention: Dietary Supplement: Fish oil

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 25, 2012): 20
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01692990
• Other Study ID Numbers: LL-spec1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: AAstrup, University of Copenhagen
• Original Responsible Party: Same as current
• Current Study Sponsor: AAstrup
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lotte Lauritzen, PhD; Department of Human Nutrition

• PRS Account: University of Copenhagen
• Verification Date: September 2012