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.

Study Overview

• Status: Completed
• Conditions: Healthy; Obesity; Insulin Resistance
• Intervention / Treatment: Other: Glucose tolerance test; Other: Fat tolerance test

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66424
      • University of Saarland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Glucose tolerance test; All participants will receive an oral standardized glucose tolerance test	Other: Glucose tolerance test; Standardized oral glucose tolerance test (75 g oral glucose) and blood collection before and 2hrs after the glucose load
Other: Fat tolerance test; The same participants will receive an oral standardized fat load test	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma malonyl-CoA	Changes between baseline and 2 hours
Plasma phosphatidylcholine	Changes between baseline and 2 hours
Plasma insulin	Changes between baseline and 2 hours
Plasma leptin	Changes between baseline and 2 hours
Plasma Lactate	Changes between baseline and 2 hours
Plasma pyruvate	Changes between baseline and 2 hours

Collaborators and Investigators

• Sponsor: Universität des Saarlandes
• Investigators: Study Director: Rima Obeid, Universität Des Saarlandes

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: Postprandial metabolomics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: will be decided at a later stage