NCT02130908

Brief Summary

This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks. Hypothesis: High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 2, 2018

Status Verified

May 1, 2018

Enrollment Period

4.3 years

First QC Date

May 1, 2014

Last Update Submit

May 1, 2018

Conditions

Metabolic DisordersObesity

Outcome Measures

Primary Outcomes (1)

  • Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum

    Endpoint after 4 weeks intervention

Secondary Outcomes (1)

  • Changes in body weight

    Endpoint after 4 weeks intervention

Study Arms (3)

Lean fish

EXPERIMENTAL
Other: Lean fish

Fatty fish

EXPERIMENTAL
Other: Fatty fish

Lean meat

EXPERIMENTAL
Other: Lean meat

Interventions

Lean fishOTHER

Participants consumed 150g of lean fish, five times per week for 4 weeks

Lean fish
Fatty fishOTHER

Participants consumed 150g of fatty fish, five times per week for 4 weeks

Fatty fish
Lean meatOTHER

Participants consumed 150g of lean meat, five times per week for 4 weeks

Lean meat

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adults
  • non-obese
  • healthy

You may not qualify if:

  • diabetes
  • diagnosed diseases of the intestine or cardiovacular system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Metabolic DiseasesObesity

Interventions

bearberry, bladderwrack, borage oil, centella, fatty acid, fish oil, ginkgo biloba, melilotus, soya lecithin drug combination

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 6, 2014

Study Start

March 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 2, 2018

Record last verified: 2018-05

Locations

NO(1)