Effects of Chronic Dietary Exposure to Branched Chain Amino Acids

NCT02684929 | Completed

• 1 other identifier: IGA NT14416
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Branched-chain amino acids (BCAA) belong among nutrients strongly linked with insulin sensitivity (IS) measures. Their exact effect on IS appears to be dependent on various conditions that remain to be better defined . The aim of the current study was to investigate effects of chronic increase of BCAA intake on IS in two groups of healthy subjects differing in their basal consumption of BCAA, i.e. vegans and omnivores. Interventional trial was designed where vegans and omnivores were separately interveined with 15 (women) or 20 (men) grams of BCAA daily. Examinations of participants are intended to be done at baseline, after the intervention and wash-out period. Examinations (anthropometry, hyperinsulinaemic-euglycaemic clamp, arginine test) and blood analyses will be performed at baseline, after the intervention and after a 6 month wash-out period. Samples of subcutaneous abdominal adipose tissue (AT) and skeletal muscle (SM, vastus lateralis) obtained before and after the intervention will be used for various analyses (mRNA levels of selected metabolic markers, fatty acid composition, mitochondrial activity).

Conditions

Type 2 Diabetes Mellitus With Features of Insulin Resistance

Keywords

insulin resistance; bcaa; mitochondrial biogenesis

Outcome Measures

Primary Outcomes (1)

• Change in glucose disposal

  glucose clamp technique; summarized in methods elsewhere

  Change from baseline to 3 months (intervention) and to 9 months (after wash-out )

Secondary Outcomes (3)

• Change in electron transport chain enzymes and citrate synthase activity

  Change from baseline to 3 months (intervention)

• Change in gene expression in skeletal muscle

  Change from baseline to 3 months (intervention)

• Change in gene expression in adipose tissue

  Change from baseline to 3 months (intervention)

Study Arms (2)

vegan

EXPERIMENTAL

Vegan subjects interveinted with oral capsules of BCAA, 15 (women) or 20 (men) grams daily for 3 months

Dietary Supplement: branched chain amino acids

omnivor

ACTIVE COMPARATOR

Omnivorous subjects iterveined with oral capsules of BCAA, 15 (women) or 20 (men) grams daily for 3 months

Dietary Supplement: branched chain amino acids

Interventions

branched chain amino acids DIETARY_SUPPLEMENT

15 (women) or 20 (men) grams of BCAA daily for 3 months

omnivor; vegan

Eligibility Criteria

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

You may qualify if:

• healthy volunteers

You may not qualify if:

• age under 18 years, any chronic disease related to energy metabolism (particularly diabetes, thyreopathy, hypertension, dyslipidemia, atherosclerosis etc.), family history of type 2 diabetes (first degree relatives), any chronic medication hormonal contraception included, smoking (even in past medical history), regular alcohol consumption and BCAA supplementation

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Centre fo Research on Diabetes, Metabolism and Nutrition, 3rd Faculty of Medicine, Charles University

Prague, Czech Republic, 100 00, Czechia

Location

Related Publications (13)

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  PMID: 24677638 BACKGROUND

• Tuma P, Gojda J. Rapid determination of branched chain amino acids in human blood plasma by pressure-assisted capillary electrophoresis with contactless conductivity detection. Electrophoresis. 2015 Aug;36(16):1969-75. doi: 10.1002/elps.201400585. Epub 2015 Apr 8.

  PMID: 25639649 BACKGROUND

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  PMID: 382871 BACKGROUND

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• Rodriguez-Palmero M, Lopez-Sabater MC, Castellote-Bargallo AI, De la Torre-Boronat MC, Rivero-Urgell M. Comparison of two methods for the determination of fatty acid profiles in plasma and erythrocytes. J Chromatogr A. 1998 Jan 16;793(2):435-40.

  PMID: 9474792 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Michal Anděl, Prof., MD

  3rd Faculty of Medicine, Charles University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 18, 2016
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

CZ (1)