Metabolic Response to Fat and Glucose

NCT02603237 | Completed

• 1 other identifier: Postprandial metabolomics
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Insulin Resistance; Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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

Study Arms (2)

Glucose tolerance test

OTHER

All participants will receive an oral standardized glucose tolerance test

Other: Glucose tolerance test

Fat tolerance test

OTHER

The same participants will receive an oral standardized fat load test

Other: Fat tolerance test

Interventions

Glucose tolerance test OTHER

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

Glucose tolerance test

Fat tolerance test OTHER

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

Fat tolerance test

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• On a stable dietary habits

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

University of Saarland

Homburg, Saarland, 66424, Germany

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Rima Obeid

  Universität des Saarlandes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. (apl.) Dr.

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 11, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

DE (1)