NCT01708681

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. 1.affect the postprandial metabolism acutely (test-meal at beginning of the study)
  2. 2.affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period)
  3. 3.affect gut microbiota composition

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

October 11, 2012

Last Update Submit

October 5, 2015

Conditions

HyperlipidemiasNutritional and Metabolic DiseasesNutrition DisordersMetabolic DiseasesGlucose Metabolism Disorders

Keywords

SeafoodMeatEggMilkPostprandial lipid metabolismPostprandial glucose metabolismTriglyceridesCholesterolPostprandial incretinsPostprandial hormones

Outcome Measures

Primary Outcomes (1)

  • Postprandial lipid measurement

    Change from baseline at 4 weeks

Secondary Outcomes (1)

  • Postprandial glucose measurement

    Change from baseline at 4 weeks

Other Outcomes (2)

  • Postprandial metabolomic measurement

    Change from baseline at 4 weeks

  • Gut microbiota composition

    Change from baseline at 4 weeks

Study Arms (2)

Lean seafood

EXPERIMENTAL

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 seafoodDietary Supplement: Meat, egg, milk

Meat, egg, milk

ACTIVE COMPARATOR

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 seafoodDietary Supplement: Meat, egg, milk

Interventions

Lean seafoodDIETARY_SUPPLEMENT
Lean seafoodMeat, egg, milk
Meat, egg, milkDIETARY_SUPPLEMENT
Lean seafoodMeat, egg, milk

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Caucasian

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Nutrition and Seafood Research

Bergen, 5005, Norway

Location

Related Publications (2)

  • 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.

    PMID: 27099232DERIVED

  • 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.

    PMID: 26224298DERIVED

Related Links

MeSH Terms

Conditions

HyperlipidemiasNutritional and Metabolic DiseasesNutrition DisordersMetabolic DiseasesGlucose Metabolism Disorders

Interventions

MeatEggsMilk

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBeveragesDairy Products

Study Officials

  • Bjørn Liaset, Dr

    NIFES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 17, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

September 1, 2015

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations

NO(1)