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Lean Seafood Intake and Postprandial Metabolism (LeSIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier:
NCT01708681
First received: October 11, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Condition Intervention
Hyperlipidemias
Nutritional and Metabolic Diseases
Nutrition Disorders
Metabolism Diseases
Glucose Metabolism Disorders
 Dietary Supplement: Lean seafood
Dietary Supplement: Meat, egg, milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Nutrition and Seafood Research, Norway:

Primary Outcome Measures:
  • Postprandial lipid measurement [ Time Frame: Change from baseline at 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial glucose measurement [ Time Frame: Change from baseline at 4 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Postprandial metabolomic measurement [ Time Frame: Change from baseline at 4 weeks ] [ Designated as safety issue: No ]
  • Gut microbiota composition [ Time Frame: Change from baseline at 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708681

Locations
Norway
National Institute of Nutrition and Seafood Research
Bergen, Norway, 5005
Sponsors and Collaborators
National Institute of Nutrition and Seafood Research, Norway
The Research Council of Norway
Investigators
Principal Investigator: Bjørn Liaset, Dr NIFES
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier: NCT01708681     History of Changes
Other Study ID Numbers: NIFES-001, 2012/1084/REK vest
Study First Received: October 11, 2012
Last Updated: January 9, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by National Institute of Nutrition and Seafood Research, Norway:
Seafood
Meat
Egg
Milk
Postprandial lipid metabolism
 Postprandial glucose metabolism
Triglycerides
Cholesterol
Postprandial incretins
Postprandial hormones

Additional relevant MeSH terms:
Hyperlipidemias
Metabolic Diseases
Nutrition Disorders
 Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 16, 2013