Metabolic Response to Fat and Glucose

Healthy Clinical Trial

Official title:

Metabolic Response to Fat and Glucose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603237
• Other study ID #: Postprandial metabolomics
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2020

Study information

• Verified date: May 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Insulin Resistance
• Obesity

Intervention

Other:
• Glucose tolerance test
Standardized oral glucose tolerance test (75 g oral glucose) and blood collection before and 2hrs after the glucose load
• Fat tolerance test
Oral fat tolerance will be provided to fasting participants and blood samples will be collected before and 4 hrs after the fat load.

Locations

Country	Name	City	State
Germany	University of Saarland	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of branched chain amino acid		Changes between baseline and 2 hours
Primary	Plasma Trimethylamin N-oxide		Changes between baseline and 2 hours
Primary	Plasma glucose level		Changes between baseline and 2 hours
Primary	Plasma glucose		Changes between baseline and 2 hours
Primary	Plasma level of acetyl-CoA		Changes between baseline and 2 hours
Secondary	Plasma malonyl-CoA		Changes between baseline and 2 hours
Secondary	Plasma phosphatidylcholine		Changes between baseline and 2 hours
Secondary	Plasma insulin		Changes between baseline and 2 hours
Secondary	Plasma leptin		Changes between baseline and 2 hours
Secondary	Plasma Lactate		Changes between baseline and 2 hours
Secondary	Plasma pyruvate		Changes between baseline and 2 hours