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Completed

NCT Number: NCT02506920

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

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

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Key information

Age range

22 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Six different types of fat in a meal in random order

Dietary Supplement

Oral fat tolerance test

Primary outcomes

  1. Postprandial cholesterol

    Time frame: Eight hours

    Cholesterols measured in milli mol per liter

  2. Postprandial free fatty acids

    Time frame: Eight hours

    Free fatty acids measured in micro equivalents per liter

Secondary outcomes

  1. Postprandial glucose

    Time frame: Eight hours

    Glucose measured in milli mol per liter

  2. postprandial insulin

    Time frame: Eight hours

    Insulin measured in pico mol per liter

Sponsors and collaborators

Lead sponsor

Herning Hospital

Other

Collaborators

  • Kolding Sygehus

Registry information

Official study title

Gender Dependent Difference in Postprandial Lipemia and Glucose Responses After Six Different Fat Tolerance Tests in Young Healthy Subjects

Important dates

Study start
1997
Primary completion
1997
Study completion
1997
First posted
Jul 23, 2015
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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