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Metabolic Response to Fat and Glucose

Primary Purpose

Obesity, Insulin Resistance, Healthy

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Glucose tolerance test

Fat tolerance test

About this trial

This is an interventional diagnostic trial for Obesity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Saarland

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Glucose tolerance test

Fat tolerance test

Arm Description

All participants will receive an oral standardized glucose tolerance test

The same participants will receive an oral standardized fat load test

Outcomes

Primary Outcome Measures

Plasma levels of branched chain amino acid

Plasma Trimethylamin N-oxide

Plasma glucose level

Plasma glucose

Plasma level of acetyl-CoA

Secondary Outcome Measures

Plasma malonyl-CoA

Plasma phosphatidylcholine

Plasma insulin

Plasma leptin

Plasma Lactate

Plasma pyruvate

Full Information

NCT ID

NCT02603237

First Posted

November 6, 2015

Last Updated

May 2, 2023

Sponsor

Universität des Saarlandes

1. Study Identification

Unique Protocol Identification Number

NCT02603237

Brief Title

Metabolic Response to Fat and Glucose

Official Title

Metabolic Response to Fat and Glucose

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universität des Saarlandes

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Insulin Resistance, Healthy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Glucose tolerance test

Arm Type

Other

Arm Description

All participants will receive an oral standardized glucose tolerance test

Arm Title

Fat tolerance test

Arm Type

Other

Arm Description

The same participants will receive an oral standardized fat load test

Intervention Type

Other

Intervention Name(s)

Glucose tolerance test

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Fat tolerance test

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma levels of branched chain amino acid

Time Frame