Incretin Effects of Branched Chain Amino Acids

NCT02697305 | Completed

• 1 other identifier: IGA NT 14416 - 2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Branched chain amino acids (BCAA) are known to exert insulinogenic effect. Whether this effect is mediated by incretins (GLP-1, GIP) is not known. The aim of the study was to show incretin effect of BCAA, i.e. whether the oral administration of BCAA elicits higher insulin and incretin response when compared with IV route of the same dose of BCAA. Eighteen healthy, male subjects participated in three tests: IV application of BCAA solution (30.7±1.1 g of BCAA, IV BCAA) second was oral ingestion of BCAA capsules in the same dose (ORAL BCAA) and third experiment was oral placebo (PLACEBO). Glucose, insulin, GLP-1, GIP, valine, leucine and isoleucine levels were measured at time interval for up to 4 h.

Conditions

Glucose Metabolism Disorders

Keywords

Insulin response; Incretin effect; GLP-1; GIP; Valine; Leucine; Isoleucine; Branched chain amino acids

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of GLP-1 and GIP

  At time 0, 15, 30, 45, 60, 90, 120 min serum levels of GLP-1 and GIP in peripheral blood samples were detected using commercially available ELISA kits

  0-120 min after administration

Secondary Outcomes (3)

• Area under the plasma concentration versus time curve (AUC) of BCAA

  0-240 min after administration

• Area under the plasma concentration versus time curve (AUC) of insulin

  0-240 min after administration

• Area under the plasma concentration versus time curve (AUC) of glucose

  0-240 min after administration

Study Arms (3)

IV BCAA test

EXPERIMENTAL

IV application of BCAA solution

Dietary Supplement: IV BCAA

ORAL BCAA test

EXPERIMENTAL

At once oral ingestion of BCAA capsules

Dietary Supplement: ORAL BCAA

ORAL PLACEBO test

PLACEBO COMPARATOR

At once oral ingestion of placebo capsules

Other: ORAL Placebo

Interventions

IV BCAA DIETARY_SUPPLEMENT

in total dose of 0,4 g/kg in a 2 h intravenous infusion

Also known as: Nutramin VLI 3%, Fresenius Kabi, KGaA, Germany

IV BCAA test

ORAL BCAA DIETARY_SUPPLEMENT

single dose of 0.4g/kg administered over 30s washed down with 500mL of tap water

Also known as: BCAA capsules, Reflex Nutrition, UK, Brighton

ORAL BCAA test

ORAL Placebo OTHER

single dose of 0.4 g/kg administered over 30 s washed down with 500mL of tap water

Also known as: methylcellulose, University Hospital Inst. Pharmacy prepared

ORAL PLACEBO test

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers

You may not qualify if:

• age under 18 years, obesity, any chronic disease related to energy metabolism (particularly diabetes, thyreopathy, hypertension, dyslipidemia, atherosclerosis etc.), any chronic medication, smoking and regular alcohol consumption

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Centre for Research on Diabetes, Metabolism and Nutrition, 3rd Faculty of Medicine, Charles University in Prague

Prague, 100 34, Czechia

Location

Related Publications (28)

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  PMID: 28595189 DERIVED

MeSH Terms

Conditions

Glucose Metabolism Disorders

Interventions

Methylcellulose

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Michal Anděl, Prof., MD

  3rd Faculty of Medicine, Charles University in Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 27, 2016
• First Posted: March 3, 2016
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)