Lean Seafood Intake and Postprandial Metabolism (LeSIP)

October 5, 2015 updated by: National Institute of Nutrition and Seafood Research, Norway

Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design

Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will:

  1. affect the postprandial metabolism acutely (test-meal at beginning of the study)
  2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period)
  3. affect gut microbiota composition

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

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

  • Norway
      • Bergen, Norway, 5005
        • National Institute of Nutrition and Seafood Research

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 years of age
  • Caucasian

Exclusion Criteria:

  • Smoking
  • Diabetes
  • Hysterectomy
  • Abnormal bleeding last 6 months
  • Use of medication that affects lipid and glucose metabolism
  • Large (>10%) alteration in body-weight the last 6 months
  • Chronic, metabolic or acute disease or major surgery within last 3 months
  • Dietary incompatibility with calcium supplementation and/ or seafood consumption (allergy, intolerance, dislike)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lean seafood
Cross-over design, half of the subject will receive lean seafood in study period I and the other half in study period II
Dietary supplement: Lean seafood
Dietary supplement: Meat, egg, milk
Active Comparator: Meat, egg, milk
Cross-over design, half of the subject will receive meat, egg, milk in study period I and the other half in study period II
Dietary supplement: Lean seafood
Dietary supplement: Meat, egg, milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postprandial lipid measurement
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Postprandial glucose measurement
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Postprandial metabolomic measurement
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks
Gut microbiota composition
Time Frame: Change from baseline at 4 weeks
Change from baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Nutrition and Seafood Research, Norway

Collaborators

The Research Council of Norway

Investigators

  • Principal Investigator: Bjørn Liaset, Dr, NIFES

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 17, 2012

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIFES-001
  • 2012/1084/REK vest (Other Grant/Funding Number: NRC-200515/I30)

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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