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OpenTrials
Completed

NCT Number: NCT01446068

Comparison of Postprandial Inflammation in Lean and Obese Subjects

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.

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Key information

Conditions

Nutritional Intervention Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Agroscope Liebefeld-Posieux ALP Research Station, Bern, Canton of Bern, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-fat meal

Dietary Supplement

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

Primary outcomes

  1. Interleukin-6 (serum)

    Time frame: 4h vs 0h

    A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h

Secondary outcomes

  1. Glucose (serum)

    Time frame: 0h, 1h, 2h, 4h, 6h

  2. Triglyceride (serum)

    Time frame: 0h, 1h, 2h, 4h, 6h

  3. Insulin (serum)

    Time frame: 0h, 1h, 2h, 4h, 6h

  4. high sensitivity C-Reactive Protein

    Time frame: 0h, 1h, 2h, 4h, 6h

  5. HDL-cholesterol

    Time frame: 0h, 1h, 2h, 4h, 6h

  6. Total cholesterol

    Time frame: 0h, 1h, 2h, 4h, 6h

  7. Total cholesterol / HDL cholesterol

    Time frame: 0h, 1h, 2h, 4h, 6h

  8. Interleukin-6 (serum)

    Time frame: 0h, 1h, 2h, 4h, 6h

  9. Glucagon-like-protein-1 (serum)

    Time frame: 0h, 1h 2h, 4h, 6h

  10. Endotoxin (serum)

    Time frame: 0h, 1h, 2h, 4h, 6h

Sponsors and collaborators

Lead sponsor

Agroscope Liebefeld-Posieux Research Station ALP

Other

Collaborators

  • Insel Gruppe AG, University Hospital Bern

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 4, 2011
Registry last updated
Jun 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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