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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01446068
Other study ID # NUTRICHIP-1
Secondary ID
Status Completed
Phase Phase 0
First received September 29, 2011
Last updated June 19, 2013
Start date March 2011
Est. completion date January 2013

Study information

Verified date June 2013
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 purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date January 2013
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria for lean subjects:

- age 25-50

- 20<BMI<25

- waist circumference <94cm

Inclusion Criteria for obese subjects

- age-matched to healthy subjects

- 30<BMI<40

- waist circumference >102cm

Exclusion Criteria for lean and obese subjects:

- Physiological or psychological diseases

- Allergies to food or intolerance to high-fat meal

- Vegetarians

- Chronic intake of drugs

- Smokers

- Diabetes mellitus Type I and II

- Debilitating kidney diseases

- Debilitating liver diseases

- Clinically established coronary heart diseases

- Ingestion of vitamins or dietary supplements during the course of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High-fat meal
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)

Locations

Country Name City State
Switzerland Agroscope Liebefeld-Posieux ALP Research Station Berne
Switzerland University Hospital Inselspital, Berne Berne

Sponsors (2)

Lead Sponsor Collaborator
Agroscope Liebefeld-Posieux Research Station ALP University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interleukin-6 (serum) A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h 4h vs 0h No
Secondary Glucose (serum) 0h, 1h, 2h, 4h, 6h No
Secondary Triglyceride (serum) 0h, 1h, 2h, 4h, 6h No
Secondary Insulin (serum) 0h, 1h, 2h, 4h, 6h No
Secondary high sensitivity C-Reactive Protein 0h, 1h, 2h, 4h, 6h No
Secondary HDL-cholesterol 0h, 1h, 2h, 4h, 6h No
Secondary Total cholesterol 0h, 1h, 2h, 4h, 6h No
Secondary Total cholesterol / HDL cholesterol 0h, 1h, 2h, 4h, 6h No
Secondary Interleukin-6 (serum) 0h, 1h, 2h, 4h, 6h No
Secondary Glucagon-like-protein-1 (serum) 0h, 1h 2h, 4h, 6h No
Secondary Endotoxin (serum) 0h, 1h, 2h, 4h, 6h No
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