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

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:

affect the postprandial metabolism acutely (test-meal at beginning of the study)
affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period)
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


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

Arms and Interventions

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

Primary Outcome Measures :

Postprandial lipid measurement [ Time Frame: Change from baseline at 4 weeks ]

Secondary Outcome Measures :

Postprandial glucose measurement [ Time Frame: Change from baseline at 4 weeks ]

Other Outcome Measures:

Postprandial metabolomic measurement [ Time Frame: Change from baseline at 4 weeks ]
Gut microbiota composition [ Time Frame: Change from baseline at 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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


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

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

Aadland EK, Graff IE, Lavigne C, Eng Ø, Paquette M, Holthe A, Mellgren G, Madsen L, Jacques H, Liaset B. Lean Seafood Intake Reduces Postprandial C-peptide and Lactate Concentrations in Healthy Adults in a Randomized Controlled Trial with a Crossover Design. J Nutr. 2016 May;146(5):1027-34. doi: 10.3945/jn.115.229278. Epub 2016 Apr 20.

Aadland EK, Lavigne C, Graff IE, Eng Ø, Paquette M, Holthe A, Mellgren G, Jacques H, Liaset B. Lean-seafood intake reduces cardiovascular lipid risk factors in healthy subjects: results from a randomized controlled trial with a crossover design. Am J Clin Nutr. 2015 Sep;102(3):582-92. doi: 10.3945/ajcn.115.112086. Epub 2015 Jul 29.


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 ( 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:


Disease Hyperlipidemias Hyperlipoproteinemias Metabolic Diseases Glucose Metabolism Disorders	Nutrition Disorders Pathologic Processes Dyslipidemias Lipid Metabolism Disorders

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