NCT02506920

Brief Summary

The investigators wanted to study the postprandial lipemia after six oral fat tolerance test with varying amounts of saturated fat in young healthy subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 1997

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

January 1, 1997

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1997

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1997

Completed
17.6 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

June 26, 2015

Last Update Submit

July 22, 2015

Conditions

Hyperlipidemia

Keywords

Postprandial lipemiaglycemic response

Outcome Measures

Primary Outcomes (2)

  • Postprandial cholesterol

    Cholesterols measured in milli mol per liter

    Eight hours

  • Postprandial free fatty acids

    Free fatty acids measured in micro equivalents per liter

    Eight hours

Secondary Outcomes (2)

  • Postprandial glucose

    Eight hours

  • postprandial insulin

    Eight hours

Study Arms (6)

Pack butter

ACTIVE COMPARATOR

Oral fat tolerance test contains: Cream, lactic acid culture, salt. Fat contents in grams: Saturated fat (SFA) 52, monounsaturated fat (MUFA) 19.1, polyunsaturated fat (PUFA) 1.6

Dietary Supplement: Six different types of fat in a meal in random order

Kjaergaarden blend butter

ACTIVE COMPARATOR

Oral fat tolerance test contains:Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 37.4, MUFA 27.3, PUFA 1.8

Dietary Supplement: Six different types of fat in a meal in random order

Blend butter

ACTIVE COMPARATOR

Oral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, salt. Fat contents in grams: SFA 23.7, MUFA 23.2, PUFA 7.8

Dietary Supplement: Six different types of fat in a meal in random order

Fish oil enriched butter

ACTIVE COMPARATOR

Oral fat tolerance test contains: Butter rapeseed oil, lactic acid culture, fish oil, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 0.7

Dietary Supplement: Six different types of fat in a meal in random order

Olive oil enriched butter

ACTIVE COMPARATOR

Oral fat tolerance test contains: Butter rapeseed oil, olive oil, lactic acid culture, salt. Fat contents in grams: SFA 22.6, MUFA 26.9, PUFA 5.7

Dietary Supplement: Six different types of fat in a meal in random order

Low saturated fat butter

ACTIVE COMPARATOR

Oral fat tolerance test contains: Butter, lactic acid culture, salt. Fat contents in grams: SFA14.9, MUFA16, PUFA 5.6

Dietary Supplement: Six different types of fat in a meal in random order

Interventions

Six different types of fat in a meal in random orderDIETARY_SUPPLEMENT

Oral fat tolerance test

Blend butterFish oil enriched butterKjaergaarden blend butterLow saturated fat butterOlive oil enriched butterPack butter

Eligibility Criteria

Age22 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Accept healthy volunteers

You may not qualify if:

  • hypercholesterolemia,
  • hypertension,
  • abuse of drugs or alcohol,
  • known kidney, liver, heart and metabolic disease
  • hormonal therapies including oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Astrup A, Dyerberg J, Elwood P, Hermansen K, Hu FB, Jakobsen MU, Kok FJ, Krauss RM, Lecerf JM, LeGrand P, Nestel P, Riserus U, Sanders T, Sinclair A, Stender S, Tholstrup T, Willett WC. The role of reducing intakes of saturated fat in the prevention of cardiovascular disease: where does the evidence stand in 2010? Am J Clin Nutr. 2011 Apr;93(4):684-8. doi: 10.3945/ajcn.110.004622. Epub 2011 Jan 26.

    PMID: 21270379BACKGROUND

  • Ryan MF, O'Grada CM, Morris C, Segurado R, Walsh MC, Gibney ER, Brennan L, Roche HM, Gibney MJ. Within-person variation in the postprandial lipemic response of healthy adults. Am J Clin Nutr. 2013 Feb;97(2):261-7. doi: 10.3945/ajcn.112.047936. Epub 2013 Jan 2.

    PMID: 23283501BACKGROUND

  • Knuth ND, Remias DB, Horowitz JF. Adding carbohydrate to a high-fat meal blunts postprandial lipemia in women and reduces meal-derived fatty acids in systemic circulation. Appl Physiol Nutr Metab. 2008 Apr;33(2):315-25. doi: 10.1139/H07-190.

    PMID: 18347687BACKGROUND

  • Tentor J, Harada LM, Nakamura RT, Gidlund M, Castilho LN, Cotta de Faria E. Sex-dependent variables in the modulation of postalimentary lipemia. Nutrition. 2006 Jan;22(1):9-15. doi: 10.1016/j.nut.2005.05.004. Epub 2005 Oct 12.

    PMID: 16226013BACKGROUND

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ole W Rasmussen, DrMedScie

    Associate Professor, Kolding Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 23, 2015

Study Start

January 1, 1997

Primary Completion

April 1, 1997

Study Completion

December 1, 1997

Last Updated

July 23, 2015

Record last verified: 2015-07