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Lean Seafood Intake and Postprandial Metabolism (LeSIP)

Primary Purpose

Hyperlipidemias, Nutritional and Metabolic Diseases, Nutrition Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lean seafood
Meat, egg, milk
Sponsored by
National Institute of Nutrition and Seafood Research, Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperlipidemias focused on measuring Seafood, Meat, Egg, Milk, Postprandial lipid metabolism, Postprandial glucose metabolism, Triglycerides, Cholesterol, Postprandial incretins, Postprandial hormones

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • National Institute of Nutrition and Seafood Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lean seafood

Meat, egg, milk

Arm Description

Cross-over design, half of the subject will receive lean seafood in study period I and the other half in study period II

Cross-over design, half of the subject will receive meat, egg, milk in study period I and the other half in study period II

Outcomes

Primary Outcome Measures

Postprandial lipid measurement

Secondary Outcome Measures

Postprandial glucose measurement

Full Information

First Posted
October 11, 2012
Last Updated
October 5, 2015
Sponsor
National Institute of Nutrition and Seafood Research, Norway
Collaborators
The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT01708681
Brief Title
Lean Seafood Intake and Postprandial Metabolism
Acronym
LeSIP
Official Title
Ability of a Lean Seafood Diet to Modulate Postprandial Metabolism in Human-beings - a Controlled Intervention Study With Cross-over Design
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Nutrition and Seafood Research, Norway
Collaborators
The Research Council of Norway

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Nutritional and Metabolic Diseases, Nutrition Disorders, Metabolic Diseases, Glucose Metabolism Disorders
Keywords
Seafood, Meat, Egg, Milk, Postprandial lipid metabolism, Postprandial glucose metabolism, Triglycerides, Cholesterol, Postprandial incretins, Postprandial hormones

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean seafood
Arm Type
Experimental
Arm Description
Cross-over design, half of the subject will receive lean seafood in study period I and the other half in study period II
Arm Title
Meat, egg, milk
Arm Type
Active Comparator
Arm Description
Cross-over design, half of the subject will receive meat, egg, milk in study period I and the other half in study period II
Intervention Type
Dietary Supplement
Intervention Name(s)
Lean seafood
Intervention Type
Dietary Supplement
Intervention Name(s)
Meat, egg, milk
Primary Outcome Measure Information:
Title
Postprandial lipid measurement
Time Frame
Change from baseline at 4 weeks
Secondary Outcome Measure Information:
Title
Postprandial glucose measurement
Time Frame
Change from baseline at 4 weeks
Other Pre-specified Outcome Measures:
Title
Postprandial metabolomic measurement
Time Frame
Change from baseline at 4 weeks
Title
Gut microbiota composition
Time Frame
Change from baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Liaset, Dr
Organizational Affiliation
NIFES
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Nutrition and Seafood Research
City
Bergen
ZIP/Postal Code
5005
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
27099232
Citation
Aadland EK, Graff IE, Lavigne C, Eng O, 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.
Results Reference
derived
PubMed Identifier
26224298
Citation
Aadland EK, Lavigne C, Graff IE, Eng O, 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.
Results Reference
derived
Links:
URL
http://www.nifes.no
Description
Related Info

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Lean Seafood Intake and Postprandial Metabolism

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