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Comparison of Postprandial Inflammation in Lean and Obese Subjects

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01446068
Enrollment
36
Registered
2011-10-04
Start date
2011-03-31
Completion date
2013-01-31
Last updated
2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Intervention, Nutritional and Metabolic Diseases, Obesity

Brief 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.

Interventions

DIETARY_SUPPLEMENTHigh-fat meal

Three caloric doses of high-fat meal (500, 1000, 1500 kcal)

Sponsors

Insel Gruppe AG, University Hospital Bern
CollaboratorOTHER
Agroscope Liebefeld-Posieux Research Station ALP
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Interleukin-6 (serum)4h vs 0hA statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h

Secondary

MeasureTime frame
Total cholesterol / HDL cholesterol0h, 1h, 2h, 4h, 6h
Interleukin-6 (serum)0h, 1h, 2h, 4h, 6h
Glucagon-like-protein-1 (serum)0h, 1h 2h, 4h, 6h
Endotoxin (serum)0h, 1h, 2h, 4h, 6h
Total cholesterol0h, 1h, 2h, 4h, 6h
Triglyceride (serum)0h, 1h, 2h, 4h, 6h
Insulin (serum)0h, 1h, 2h, 4h, 6h
high sensitivity C-Reactive Protein0h, 1h, 2h, 4h, 6h
HDL-cholesterol0h, 1h, 2h, 4h, 6h
Glucose (serum)0h, 1h, 2h, 4h, 6h

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026