- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506920
Gender Dependent Difference in Lipemia After 6 x OFTT in Young Healthy Subjects
Gender Dependent Difference in Postprandial Lipemia and Glucose Responses After Six Different Fat Tolerance Tests in Young Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Oral fat tolerance test
|
Active Comparator: 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
|
Oral fat tolerance test
|
Active Comparator: 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
|
Oral fat tolerance test
|
Active Comparator: 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
|
Oral fat tolerance test
|
Active Comparator: 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
|
Oral fat tolerance test
|
Active Comparator: Low saturated fat butter
Oral fat tolerance test contains: Butter, lactic acid culture, salt.
Fat contents in grams: SFA14.9,
MUFA16, PUFA 5.6
|
Oral fat tolerance test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial cholesterol
Time Frame: Eight hours
|
Cholesterols measured in milli mol per liter
|
Eight hours
|
Postprandial free fatty acids
Time Frame: Eight hours
|
Free fatty acids measured in micro equivalents per liter
|
Eight hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glucose
Time Frame: Eight hours
|
Glucose measured in milli mol per liter
|
Eight hours
|
postprandial insulin
Time Frame: Eight hours
|
Insulin measured in pico mol per liter
|
Eight hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ole W Rasmussen, DrMedScie, Associate Professor, Kolding Hospital, Denmark
Publications and helpful links
General Publications
- 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.
- 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].
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gender and PPL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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