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Lean Seafood Intake and Postprandial Metabolism (LeSIP)

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ClinicalTrials.gov Identifier: NCT01708681
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : October 6, 2015
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
National Institute of Nutrition and Seafood Research, Norway

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Hyperlipidemias Nutritional and Metabolic Diseases Nutrition Disorders Metabolic Diseases Glucose Metabolism Disorders Dietary Supplement: Lean seafood Dietary Supplement: Meat, egg, milk Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Postprandial lipid measurement [ Time Frame: Change from baseline at 4 weeks ]

Secondary Outcome Measures :
  1. Postprandial glucose measurement [ Time Frame: Change from baseline at 4 weeks ]

Other Outcome Measures:
  1. Postprandial metabolomic measurement [ Time Frame: Change from baseline at 4 weeks ]
  2. Gut microbiota composition [ Time Frame: Change from baseline at 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708681


Locations
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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
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Principal Investigator: Bjørn Liaset, Dr NIFES
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier: NCT01708681    
Other Study ID Numbers: NIFES-001
2012/1084/REK vest ( Other Grant/Funding Number: NRC-200515/I30 )
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015
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:
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Hyperlipidemias
Metabolic Diseases
Glucose Metabolism Disorders
Nutrition Disorders
 Disease
Pathologic Processes
Dyslipidemias
Lipid Metabolism Disorders