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Completed

NCT Number: NCT01708681

Lean Seafood Intake and Postprandial Metabolism

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

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Key information

Conditions

Hyperlipidemias Dyslipidemias Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Nutrition and Seafood Research

Bergen, 5005, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lean seafood

Dietary Supplement

Meat, egg, milk

Dietary Supplement

Primary outcomes

  1. Postprandial lipid measurement

    Time frame: Change from baseline at 4 weeks

Secondary outcomes

  1. Postprandial glucose measurement

    Time frame: Change from baseline at 4 weeks

Other outcomes

  1. Postprandial metabolomic measurement

    Time frame: Change from baseline at 4 weeks

  2. Gut microbiota composition

    Time frame: Change from baseline at 4 weeks

Sponsors and collaborators

Lead sponsor

National Institute of Nutrition and Seafood Research, Norway

Other Gov

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Acronym: LeSIP

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Oct 17, 2012
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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