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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506920
• Other study ID #: Gender and PPL
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: July 22, 2015
• Start date: January 1997
• Est. completion date: December 1997

Study information

• Verified date: July 2015
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 1997
• Est. primary completion date: April 1997
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Six different types of fat in a meal in random order
Oral fat tolerance test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Herning Hospital	Kolding Sygehus

References & Publications (4)

Astrup A, Dyerberg J, Elwood P, Hermansen K, Hu FB, Jakobsen MU, Kok FJ, Krauss RM, Lecerf JM, LeGrand P, Nestel P, Risérus 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. Review. — View 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. — View 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]. — View 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. Epub 2005 Oct 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial cholesterol	Cholesterols measured in milli mol per liter	Eight hours
Primary	Postprandial free fatty acids	Free fatty acids measured in micro equivalents per liter	Eight hours
Secondary	Postprandial glucose	Glucose measured in milli mol per liter	Eight hours
Secondary	postprandial insulin	Insulin measured in pico mol per liter	Eight hours