Gender Dependent Difference in Lipemia After 6 x OFTT in Young Healthy Subjects

NCT ID: NCT02506920

Last Updated: 2015-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

1997-12-31

Brief Summary

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

Detailed Description

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With six different types of butter added in random order to potatoes the investigators studied postprandial lipemia (PPL), lipoprotein, glucose, and insulin increments for eight hours in 14 young, lean, healthy students, seven of each gender.

The six, isocaloric meals contained 55.1 g carbohydrate, 5.8 g protein, 82.3 g fat, and 4177 kJ. The potatoes, without skin, were boiled in 20 minutes in excess of water with 5 g of salt added, were blended in 4 minutes and served hot. The meals were ingested over 10 minutes, with 250 ml tap water. The following 8 hours the participants stayed at the clinic to watch television, read or take a short walk of 10 minutes.

Blood samples were drawn at -15, 0, 30, 60, 90,120,180,240,300,360, 420 and 480 minutes after the meals and processed after each drawing. After blood collection, plasma was immediately separated by centrifugation at 3000 rpm for 10 minutes at 4°C.

The area under the curve (AUC) were determined for TG, HDL, LDL, total cholesterol, FFA, insulin, and glucose concentrations by the trapezoid method. Multiple regression was performed to adjust for age, gender, meals, and BMI to the variance of postprandial responses. The difference between meals were tested with ANOVA. If p\<0.05 in ANOVA, post-hoc-testing with Student-Newman-Keul's test was performed to identify, which meal was significantly different from the other, and to minimize the risk of error by multiple testing.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Pack butter

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

Group Type ACTIVE_COMPARATOR

Six different types of fat in a meal in random order

Intervention Type DIETARY_SUPPLEMENT

Oral fat tolerance test

Kjaergaarden blend butter

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

Group Type ACTIVE_COMPARATOR

Six different types of fat in a meal in random order

Intervention Type DIETARY_SUPPLEMENT

Oral fat tolerance test

Blend butter

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

Group Type ACTIVE_COMPARATOR

Six different types of fat in a meal in random order

Intervention Type DIETARY_SUPPLEMENT

Oral fat tolerance test

Fish oil enriched butter

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

Group Type ACTIVE_COMPARATOR

Six different types of fat in a meal in random order

Intervention Type DIETARY_SUPPLEMENT

Oral fat tolerance test

Olive oil enriched butter

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

Group Type ACTIVE_COMPARATOR

Six different types of fat in a meal in random order

Intervention Type DIETARY_SUPPLEMENT

Oral fat tolerance test

Low saturated fat butter

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

Group Type ACTIVE_COMPARATOR

Six different types of fat in a meal in random order

Intervention Type DIETARY_SUPPLEMENT

Oral fat tolerance test

Interventions

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Six different types of fat in a meal in random order

Oral fat tolerance test

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Accept healthy volunteers

Exclusion Criteria

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

22 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kolding Sygehus

OTHER

Sponsor Role collaborator

Herning Hospital

OTHER

Sponsor Role lead

Responsible Party

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Finn Friis Lauszus

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ole W Rasmussen, DrMedScie

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Kolding Hospital, Denmark

References

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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.

Reference Type BACKGROUND
PMID: 21270379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23283501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18347687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16226013 (View on PubMed)

Other Identifiers

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Gender and PPL

Identifier Type: -

Identifier Source: org_study_id

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