Metabolic Response to Fat and Glucose

NCT ID: NCT02603237

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity Insulin Resistance Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glucose tolerance test

All participants will receive an oral standardized glucose tolerance test

Group Type OTHER

Glucose tolerance test

Intervention Type OTHER

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

Fat tolerance test

The same participants will receive an oral standardized fat load test

Group Type OTHER

Fat tolerance test

Intervention Type OTHER

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

Interventions

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Glucose tolerance test

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Rima Obeid

Prof. (apl.) Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rima Obeid

Role: STUDY_DIRECTOR

Universität des Saarlandes

Locations

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University of Saarland

Homburg, Saarland, Germany

Site Status

Countries

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Germany

Other Identifiers

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Postprandial metabolomics

Identifier Type: -

Identifier Source: org_study_id

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