Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal

Obesity Clinical Trial

Official title:

Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995110
• Other study ID #: NUTRICHIP-1-transcriptome
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: April 23, 2014
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Agroscope Liebefeld-Posieux Research Station ALP
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria for normal weight subjects:

• age 25-50

• 20<BMI>25

• waist circumference <94cm

Inclusion Criteria for obese subjects:

• age 25-50

• 30<BMI>40

• waist circumference >102cm

Exclusion Criteria for both groups:

• physiological or psychological diseases

• allergies to food or intolerance to high-fat meal

• vegetarians, vegans

• chronic intake of drugs

• smokers

• diabetes mellitus type I and II

• debiliating kidney disease

• debiliating liver disease

• clinically established coronary heart diseases

• ingestion of vitamins or dietary supplements during the course of the study

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nutritional Intervention
• Obesity

Intervention

Other:
• high-fat meal A

• high-fat meal B

• high-fat meal C

Locations

Country	Name	City	State
Switzerland	Agroscope	Berne
Switzerland	University Hospital Inselspital Berne	Berne

Sponsors (1)

Lead Sponsor	Collaborator
Agroscope Liebefeld-Posieux Research Station ALP

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood cell transkriptome/ gene-expression	differently expressed genes between normal weight and obese subjects at baseline; changes in gene-expression 2, 4 and 6h after consumption	0h, 2h, 4h, 6h	No