NCT01692990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1 obesity

Timeline
Completed

Started Oct 2011

Shorter than P25 for early_phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
Last Updated

November 12, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

May 14, 2012

Last Update Submit

November 9, 2012

Conditions

Keywords

AppetiteFish oilLong-chain n-3 fatty acids

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Weight change

    October 7th - November 25th 2011

Study Arms (2)

Fish oil

EXPERIMENTAL

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

Dietary Supplement: Fish oil

Soy bean oil

PLACEBO COMPARATOR

5 g/d in 10 capsules

Dietary Supplement: Fish oil

Interventions

Fish oilDIETARY_SUPPLEMENT

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

Fish oilSoy bean oil

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal weight (18.5\<BMI\<25 kg/m2).
  • Healthy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

ObesityCachexia

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesThinness

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Lotte Lauritzen, PhD

    Department of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professore Lotte Lauritzen

Study Record Dates

First Submitted

May 14, 2012

First Posted

September 26, 2012

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 12, 2012

Record last verified: 2012-09

Locations