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OpenTrials
Completed

NCT Number: NCT02603237

Metabolic Response to Fat and Glucose

The study will compare plasma and urine post-prandial metabolomics after fat and glucose oral load according to lifestyle factors.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Healthy Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saarland

Homburg, Saarland, 66424, Germany

About this study

The metabolic response in plasma and urine, pre- and post-load tests in people with specific dietary lifestyles will be tested. This project will focus on fat and glucose induced changes of targeted metabolic pathways that have been related to diabetes and obesity risk.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • On a stable dietary habits

Exclusion criteria

  • Pregnancy
  • Malabsorption disorders
  • Present or former cancer
  • Any oral medication that affect glucose or fat absorptions
  • Cholesterol lowering drugs (i.e. Statins)
  • other drugs: fibrates, MTX, or vitamin supplements
  • Diabetes (type 1 and type 2)
  • Alcoholism
  • Weight losing diet during the last 4 months
  • Liver diseases
  • Renal dysfunction
  • Gastric resection.

Treatment and study plan

Glucose tolerance test

Other

Standardized oral glucose tolerance test (75 g oral glucose) and blood collection before and 2hrs after the glucose load

Fat tolerance test

Other

Oral fat tolerance will be provided to fasting participants and blood samples will be collected before and 4 hrs after the fat load.

Primary outcomes

  1. Plasma levels of branched chain amino acid

    Time frame: Changes between baseline and 2 hours

  2. Plasma Trimethylamin N-oxide

    Time frame: Changes between baseline and 2 hours

  3. Plasma glucose level

    Time frame: Changes between baseline and 2 hours

  4. Plasma glucose

    Time frame: Changes between baseline and 2 hours

  5. Plasma level of acetyl-CoA

    Time frame: Changes between baseline and 2 hours

Secondary outcomes

  1. Plasma malonyl-CoA

    Time frame: Changes between baseline and 2 hours

  2. Plasma phosphatidylcholine

    Time frame: Changes between baseline and 2 hours

  3. Plasma insulin

    Time frame: Changes between baseline and 2 hours

  4. Plasma leptin

    Time frame: Changes between baseline and 2 hours

  5. Plasma Lactate

    Time frame: Changes between baseline and 2 hours

  6. Plasma pyruvate

    Time frame: Changes between baseline and 2 hours

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Nov 11, 2015
Registry last updated
May 6, 2023

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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