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

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Six different types of fat in a meal in random order
Sponsored by
Herning Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperlipidemia focused on measuring Postprandial lipemia, glycemic response

Eligibility Criteria

22 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Pack butter

    Kjaergaarden blend butter

    Blend butter

    Fish oil enriched butter

    Olive oil enriched butter

    Low saturated fat butter

    Arm Description

    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

    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

    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

    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

    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

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

    Outcomes

    Primary Outcome Measures

    Postprandial cholesterol
    Cholesterols measured in milli mol per liter
    Postprandial free fatty acids
    Free fatty acids measured in micro equivalents per liter

    Secondary Outcome Measures

    Postprandial glucose
    Glucose measured in milli mol per liter
    postprandial insulin
    Insulin measured in pico mol per liter

    Full Information

    First Posted
    June 26, 2015
    Last Updated
    July 22, 2015
    Sponsor
    Herning Hospital
    Collaborators
    Kolding Sygehus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02506920
    Brief Title
    Gender Dependent Difference in Lipemia After 6 x OFTT in Young Healthy Subjects
    Official Title
    Gender Dependent Difference in Postprandial Lipemia and Glucose Responses After Six Different Fat Tolerance Tests in Young Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1997 (undefined)
    Primary Completion Date
    April 1997 (Actual)
    Study Completion Date
    December 1997 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Herning Hospital
    Collaborators
    Kolding Sygehus

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipidemia
    Keywords
    Postprandial lipemia, glycemic response

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Pack butter
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Kjaergaarden blend butter
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Blend butter
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Fish oil enriched butter
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Olive oil enriched butter
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Low saturated fat butter
    Arm Type
    Active Comparator
    Arm Description
    Oral fat tolerance test contains: Butter, lactic acid culture, salt. Fat contents in grams: SFA14.9, MUFA16, PUFA 5.6
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Six different types of fat in a meal in random order
    Intervention Description
    Oral fat tolerance test
    Primary Outcome Measure Information:
    Title
    Postprandial cholesterol
    Description
    Cholesterols measured in milli mol per liter
    Time Frame
    Eight hours
    Title
    Postprandial free fatty acids
    Description
    Free fatty acids measured in micro equivalents per liter
    Time Frame
    Eight hours
    Secondary Outcome Measure Information:
    Title
    Postprandial glucose
    Description
    Glucose measured in milli mol per liter
    Time Frame
    Eight hours
    Title
    postprandial insulin
    Description
    Insulin measured in pico mol per liter
    Time Frame
    Eight hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    28 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ole W Rasmussen, DrMedScie
    Organizational Affiliation
    Associate Professor, Kolding Hospital, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21270379
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23283501
    Citation
    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. Erratum In: Am J Clin Nutr. 2014 Oct;100(4):1214. Grada, Colm O [corrected to O'Grada, Colm M].
    Results Reference
    background
    PubMed Identifier
    18347687
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16226013
    Citation
    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.
    Results Reference
    background

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

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