Metabolic Response to Fat and Glucose

Not Applicable

Completed

• Conditions: Healthy; Obesity; Insulin Resistance
• Interventions: Other: Fat tolerance test; Other: Glucose tolerance test

• Registration Number: NCT02603237
• Lead Sponsor: Universität des Saarlandes

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Study Start: 2016-07
• Primary Completion: 2019-12
• Study Completion: 2020-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy volunteers
• On a stable dietary habits

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fat tolerance test	Fat tolerance test	The same participants will receive an oral standardized fat load test
Glucose tolerance test	Glucose tolerance test	All participants will receive an oral standardized glucose tolerance test

Primary Outcome Measures

Name	Time	Method
Plasma levels of branched chain amino acid	Changes between baseline and 2 hours
Plasma level of acetyl-CoA	Changes between baseline and 2 hours
Plasma Trimethylamin N-oxide	Changes between baseline and 2 hours
Plasma glucose	Changes between baseline and 2 hours
Plasma glucose level	Changes between baseline and 2 hours

Secondary Outcome Measures

Name	Time	Method
Plasma insulin	Changes between baseline and 2 hours
Plasma Lactate	Changes between baseline and 2 hours
Plasma leptin	Changes between baseline and 2 hours
Plasma malonyl-CoA	Changes between baseline and 2 hours
Plasma phosphatidylcholine	Changes between baseline and 2 hours
Plasma pyruvate	Changes between baseline and 2 hours

Trial Locations

Locations (1)

University of Saarland; 🇩🇪 Homburg, Saarland, Germany