Type 2 Diabetes Mellitus With Features of Insulin ResistanceNCT02684929
Effects of Chronic Dietary Exposure to Branched Chain Amino Acids
A study testing branched chain amino acids in people with Type 2 Diabetes Mellitus With Features of Insulin Resistance, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus With Features of Insulin Resistance
- What is being tested?
- branched chain amino acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCzechia
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Centre fo Research on Diabetes, Metabolism and Nutrition, 3rd Faculty of Medicine, Charles University
Prague, Czech Republic, 100 00
About this study
Official title: Effects of Chronic Dietary Exposure to Branched Chain Amino Acids on Insulin Sensitivity Measures in Healthy Vegans and Omnivores
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).
Read the detailed description
Subjects and methods Listed elsewhere Intervention Listed elsewhere
Clinical examination Each subject underwent a basic medical check-up with anthropometric examination (height (m), weight (kg), BMI (kg/m2), waist circumference (cm), waist-hip ratio). Body composition was measured using bioimpedance analysis (BIA, Nutriguard-M, Data Input GmbH, Germany). Each of above mentioned measurements was performed three times and mean was recorded.
Dietary assessment Each participant filled in a prospective questionnaire, where dietary data from 3 days were collected (2 working days, 1 weekend day). For dietary intake calculations Nutridan program was used. As nutritional data of some special vegan products are not available in the database, vegans were asked to collect packages from these products with producer declared nutritional content, and these data were used for calculations. Saccharides, lipid and protein intake were calculated separately. BCAA content of dietary proteins was estimated using nutritional database.
Physical activity assessment Physical activity was assessed in the whole sample using Baecke questionnaire for habitual physical activity [1], that correlates well with maximum oxygen consumption (VO2max)[2]. Maximal exercise test was performed in each subject on an electromagnetically braked bicycle ergometer (Ergoline 800, Bitz, Germany) to determine peak oxygen uptake (Vo2peak). An initial workload of 50W was increased by 25 W every minute continuously until fatigue despite the verbal encouragement. Oxygen uptake was measured using Vmax, Sensor Medics (Yorba Linda, CA). Heart rate was monitored continuously.
Laboratory analysis Peripheral venous blood was drawn from each subject after 12 hours of fasting. Parameters of glucose homeostasis were assessed in certified University hospital laboratory: plasma glucose using hexokinase reaction (kit KONELAB, Germany), HbA1c using high-pressure liquid boronate afinit chromatography (Primus corporation), insulin using solid phase competitive chemiluminescent enzyme immunoassay (Immulite 2000). Lipid profile: total cholesterol and triglycerides were measured using enzymatic method (kit KONELAB, Germany), HDL-cholesterol using PEG modified enzymatic measurement (kit ROCHE, Switzerland). Plasma levels of free fatty acids (FFA) were measured using method already described [12]. Briefly, FFA were extracted together with neutral lipids using isooctan and cleaned by reverse extraction. FA obtained this way were derivatized to methylesters and subsequently analyzed using gas chromatography (GC). Serum AA levels were determined using capillary electrophoresis (CE) with contactless conductivity detection, which has been already described in details [3, 4]. CE measurements were carried out using HP3DCE system (Agilent Technologies, Waldbronn, Germany) equipped with a built-in contactless conductivity detector.
Insulin sensitivity and secretion IS was assessed using 2-hours hyperinsulinaemic euglycaemic clamp, method described elsewhere[5]. Clamp was performed after 12-hours fasting in a standard insulin dose 1mIU/kg/min and an infusion of 15 % glucose solution was used. Mean infusion rate in steady-state of the clamp (6 consecutive measurements) was used for measurements. Glucose disposal was expressed as metabolic clearance rate (MCR, ml.kg-1.min-1) after correction for changes in glucose pool in extracellular fluid (space correction) and insulin sensitivity index (MCR divided by stady state insulinaemia, MCR/I, ml.kg-1.min-1/mU.l-1). Insulin secretion was assessed by IV arginine test as already described [6] performed on a different day (at about 7 days in between) from glucose clamp. Acute insulin response was calculated as the incremental trapezoidal area for insulin during the 30 min of the test.
Muscle biopsy, respiratory chain, and citrate synthase enzymes activities Skeletal muscle sample from vastus lateralis muscle was performed in every participant using a standard Bergström technique[7, 8]. Biopsy was performed at fasting conditions. About 200 mg of wet weight was obtained. The sample was immediately microdissected, weighed, divided for respective analyses and snap-frozen in liquid nitrogen and stored in -80oC until analyses.
Mitochondrial respiratory chain (RC) enzymatic activity and citrate synthase (CS) activity were measured spectrophotometrically in muscle homogenates. Muscle homogenates were prepared as described [9]. Briefly, about 50 mg of SM was cut into small fragments and homogenized (glass-glass grinder) in 20 volumes of ice-cold homogenization buffer (250 mM sucrose, 20 mM Tris, 40 mM KCl, 2 mM EGTA, protease inhibitor cocktail, pH 7.4). The homogenates were then centrifuged for 1 min at 600g at 4°C and the supernatants were immediately used for analysis. Protein concentration was measured in aliquots using the bicinchoninic acid (BCA) assay (Sigma). Activity of complex I-IV and CS was determined accordingly to previously published protocols [10-11], that were modified for measurement in a microplate reader (Infinite M200 PRO, Tecan). All measurements were made in tetraplicates. Activities of RC and CS were expressed as nmol/min/mg of total proteins, except for complex IV, which was expressed as Δ log (A550)/min/mg of total proteins. The enzymatic activities of the RC complexes were also normalized to the activity of CS, which is used as a marker of the abundance of mitochondria within a tissue.
Adipose tissue biopsy Subcutaneous abdominal adipose tissue (SAAT) biopsy was performed in every participant. Bergström needle was used to obtain samples of subcutaneous fat from paraumbilical area as already described [12]. Biopsy was performed at fasting conditions. About 300 mg of wet weight was obtained. The sample was immediately microdissected, weighed, divided for respective analyses and snap-frozen in liquid nitrogen and stored in -80oC until analyses.
Quantitative real time PCR (RT-qPCR) Total RNA from tissues was isolated using Lipid Tissue and Fibrous Tissue RNeasy Mini Kits (Qiagen). RNA concentration was measured by Nanodrop1000 (Thermo Fisher Scientific, Wilmington, USA). RNA was treated with DNAse I (Invitrogen, Carlsbad CA, USA) to remove any contaminating genomic DNA. cDNA was prepared from 200- 600 ng of RNA using High Capacity cDNA archive kit (Applied Biosystems, Carlsbad CA, USA). Equivalent of 5 ng of RNA was used for Real Time PCR reactions using Fast Advanced master mix and Gene expression assay (IRS1, GLUT4, BCKDHA, BCKDHB, ACOX, CPT1b, PLIN1, PLIN2, PLIN5, FASN, SCD1, DGAT2, PPAR-γ; Applied Biosystems). All samples were run in duplicates. Gene expression of target genes was normalized to expression of RPS13 (glucuronidase, beta) and fold change of expression was calculated using delta delta Ct method.
Fatty acid spectrum in AT Fatty acid spectrum in AT was assessed using gas chromatography, a method already described by Lepage and Roy [13] with modifications by Rodriguez-Palmero et al. [14] In brief, the method involves a chloroform/methanol extraction of freeze-dried AT to isolate lipids and subsequent transesterification or esterification of FA bound to lipids to form methyl esters, which were then analyzed using gas chromatography.
Statistical analysis Data are presented in text, tables, and figures as means ± SD with 95 % CI and p-values <0.05 were considered statistically significant. Student t-test was used in observational samples for normally distributed data. Wilcoxon matched pairs test was used when data were not normally distributed. Intervention samples were compared using a general linear model to test the statistical significance of differences between groups. A mixed model ANOVA was used to assess group × time interaction. Within each group time effects of the intervention were assessed using repeated measures ANOVA with Bonferroni's multiple comparison. Where there were only two data sets within each group (i.e. only baseline and intervention data as in data obtained from tissue biopsies) paired t-tests were used for normally distributed data and Wilcoxon test when data were not normally distributed. Pearson's correlation coefficient was calculated to express relationship between changes from baseline to intervention for normally distributed data and Spearman's correlation coefficient was calculated when data were not normally distributed. Statistica 9.0, StatSoft, Inc. USA was used to perform all statistical procedures.
- Being tested
- branched chain amino acids
- Keywords
- insulin resistance, bcaa, mitochondrial biogenesis
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
branched chain amino acidsDietary supplement
15 (women) or 20 (men) grams of BCAA daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| vegan | Experimental | Vegan subjects interveinted with oral capsules of BCAA, 15 (women) or 20 (men) grams daily for 3 months Receives: 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 Receives: Dietary Supplement: branched chain amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose disposal
glucose clamp technique; summarized in methods elsewhere
Measured: 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
activity of electron transport chain complexes and citrate synthase, spectroscopy; summarized in methods elsewhere
Measured: Change from baseline to 3 months (intervention)
Change in gene expression in skeletal muscle
Insulin function (IRS1, GLUT4), BCAA metabolism (BCKDHA, BCKDHB), fatty acid oxidation (ACOX, CPT1b) and lipogenesis (perilipin: PLIN2, PLIN5). All assessed by RT PCR, all in delta delta Ct method; summarized in methods elsewhere
Measured: Change from baseline to 3 months (intervention)
Change in gene expression in adipose tissue
glucose uptake (IRS1, GLUT4), BCAA metabolism (BCKDHA, BCKDHB) and lipogenesis (PPAR-γ, fatty acid synthase, stearoyl-coenzyme A desaturase 1 and 5, diglycerol acyl transferase 2, perilipin: PLIN1, PLIN2). All assessed by RT PCR, all in delta delta Ct method; summarized in methods elsewhere
Measured: Change from baseline to 3 months (intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus With Features of Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUDr. Radka Straková, Charles University, Czech Republic
- Investigators
- Michal Anděl, Prof., MD, Principal investigator, 3rd Faculty of Medicine, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684929
- Sponsor's protocol ID
- IGA NT14416
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.
PubMed 7137077Florindo AA, Latorre Mdo R, Santos EC, Negrao CE, Azevedo LF, Segurado AA. Validity and reliability of the Baecke questionnaire for the evaluation of habitual physical activity among people living with HIV/AIDS. Cad Saude Publica. 2006 Mar;22(3):535-41. doi: 10.1590/s0102-311x2006000300008. Epub 2006 Mar 27.
PubMed 16583097Tuma P. Rapid determination of globin chains in red blood cells by capillary electrophoresis using INSTCoated fused-silica capillary. J Sep Sci. 2014 Apr;37(8):1026-32. doi: 10.1002/jssc.201400044. Epub 2014 Mar 13.
PubMed 24677638Tuma 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.
PubMed 25639649DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
PubMed 382871Palmer JP, Benson JW, Walter RM, Ensinck JW. Arginine-stimulated acute phase of insulin and glucagon secretion in diabetic subjects. J Clin Invest. 1976 Sep;58(3):565-70. doi: 10.1172/JCI108502.
PubMed 783201Bergstrom J. Percutaneous needle biopsy of skeletal muscle in physiological and clinical research. Scand J Clin Lab Invest. 1975 Nov;35(7):609-16. No abstract available.
PubMed 1108172Spinazzi M, Casarin A, Pertegato V, Salviati L, Angelini C. Assessment of mitochondrial respiratory chain enzymatic activities on tissues and cultured cells. Nat Protoc. 2012 May 31;7(6):1235-46. doi: 10.1038/nprot.2012.058.
PubMed 22653162Janssen AJ, Trijbels FJ, Sengers RC, Smeitink JA, van den Heuvel LP, Wintjes LT, Stoltenborg-Hogenkamp BJ, Rodenburg RJ. Spectrophotometric assay for complex I of the respiratory chain in tissue samples and cultured fibroblasts. Clin Chem. 2007 Apr;53(4):729-34. doi: 10.1373/clinchem.2006.078873. Epub 2007 Mar 1.
PubMed 17332151COOPERSTEIN SJ, LAZAROW A. A microspectrophotometric method for the determination of cytochrome oxidase. J Biol Chem. 1951 Apr;189(2):665-70. No abstract available.
PubMed 14832284Alderete TL, Sattler FR, Sheng X, Tucci J, Mittelman SD, Grant EG, Goran MI. A novel biopsy method to increase yield of subcutaneous abdominal adipose tissue. Int J Obes (Lond). 2015 Jan;39(1):183-6. doi: 10.1038/ijo.2014.90. Epub 2014 May 21.
PubMed 24849392Lepage G, Roy CC. Direct transesterification of all classes of lipids in a one-step reaction. J Lipid Res. 1986 Jan;27(1):114-20.
PubMed 3958609Rodriguez-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.
PubMed 9474792
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Dietary Exposure to Branched Chain Amino Acids on Insulin Sensitivity Measures in Healthy Vegans and Omnivores
- ClinicalTrials.gov ID
- NCT02684929
- Acronym / sponsor ID
- IGA NT14416
- Keywords
- insulin resistance, bcaa, mitochondrial biogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Subjects and methods Listed elsewhere Intervention Listed elsewhere
Clinical examination Each subject underwent a basic medical check-up with anthropometric examination (height (m), weight (kg), BMI (kg/m2), waist circumference (cm), waist-hip ratio). Body composition was measured using bioimpedance analysis (BIA, Nutriguard-M, Data Input GmbH, Germany). Each of above mentioned measurements was performed three times and mean was recorded.
Dietary assessment Each participant filled in a prospective questionnaire, where dietary data from 3 days were collected (2 working days, 1 weekend day). For dietary intake calculations Nutridan program was used. As nutritional data of some special vegan products are not available in the database, vegans were asked to collect packages from these products with producer declared nutritional content, and these data were used for calculations. Saccharides, lipid and protein intake were calculated separately. BCAA content of dietary proteins was estimated using nutritional database.
Physical activity assessment Physical activity was assessed in the whole sample using Baecke questionnaire for habitual physical activity [1], that correlates well with maximum oxygen consumption (VO2max)[2]. Maximal exercise test was performed in each subject on an electromagnetically braked bicycle ergometer (Ergoline 800, Bitz, Germany) to determine peak oxygen uptake (Vo2peak). An initial workload of 50W was increased by 25 W every minute continuously until fatigue despite the verbal encouragement. Oxygen uptake was measured using Vmax, Sensor Medics (Yorba Linda, CA). Heart rate was monitored continuously.
Laboratory analysis Peripheral venous blood was drawn from each subject after 12 hours of fasting. Parameters of glucose homeostasis were assessed in certified University hospital laboratory: plasma glucose using hexokinase reaction (kit KONELAB, Germany), HbA1c using high-pressure liquid boronate afinit chromatography (Primus corporation), insulin using solid phase competitive chemiluminescent enzyme immunoassay (Immulite 2000). Lipid profile: total cholesterol and triglycerides were measured using enzymatic method (kit KONELAB, Germany), HDL-cholesterol using PEG modified enzymatic measurement (kit ROCHE, Switzerland). Plasma levels of free fatty acids (FFA) were measured using method already described [12]. Briefly, FFA were extracted together with neutral lipids using isooctan and cleaned by reverse extraction. FA obtained this way were derivatized to methylesters and subsequently analyzed using gas chromatography (GC). Serum AA levels were determined using capillary electrophoresis (CE) with contactless conductivity detection, which has been already described in details [3, 4]. CE measurements were carried out using HP3DCE system (Agilent Technologies, Waldbronn, Germany) equipped with a built-in contactless conductivity detector.
Insulin sensitivity and secretion IS was assessed using 2-hours hyperinsulinaemic euglycaemic clamp, method described elsewhere[5]. Clamp was performed after 12-hours fasting in a standard insulin dose 1mIU/kg/min and an infusion of 15 % glucose solution was used. Mean infusion rate in steady-state of the clamp (6 consecutive measurements) was used for measurements. Glucose disposal was expressed as metabolic clearance rate (MCR, ml.kg-1.min-1) after correction for changes in glucose pool in extracellular fluid (space correction) and insulin sensitivity index (MCR divided by stady state insulinaemia, MCR/I, ml.kg-1.min-1/mU.l-1). Insulin secretion was assessed by IV arginine test as already described [6] performed on a different day (at about 7 days in between) from glucose clamp. Acute insulin response was calculated as the incremental trapezoidal area for insulin during the 30 min of the test.
Muscle biopsy, respiratory chain, and citrate synthase enzymes activities Skeletal muscle sample from vastus lateralis muscle was performed in every participant using a standard Bergström technique[7, 8]. Biopsy was performed at fasting conditions. About 200 mg of wet weight was obtained. The sample was immediately microdissected, weighed, divided for respective analyses and snap-frozen in liquid nitrogen and stored in -80oC until analyses.
Mitochondrial respiratory chain (RC) enzymatic activity and citrate synthase (CS) activity were measured spectrophotometrically in muscle homogenates. Muscle homogenates were prepared as described [9]. Briefly, about 50 mg of SM was cut into small fragments and homogenized (glass-glass grinder) in 20 volumes of ice-cold homogenization buffer (250 mM sucrose, 20 mM Tris, 40 mM KCl, 2 mM EGTA, protease inhibitor cocktail, pH 7.4). The homogenates were then centrifuged for 1 min at 600g at 4°C and the supernatants were immediately used for analysis. Protein concentration was measured in aliquots using the bicinchoninic acid (BCA) assay (Sigma). Activity of complex I-IV and CS was determined accordingly to previously published protocols [10-11], that were modified for measurement in a microplate reader (Infinite M200 PRO, Tecan). All measurements were made in tetraplicates. Activities of RC and CS were expressed as nmol/min/mg of total proteins, except for complex IV, which was expressed as Δ log (A550)/min/mg of total proteins. The enzymatic activities of the RC complexes were also normalized to the activity of CS, which is used as a marker of the abundance of mitochondria within a tissue.
Adipose tissue biopsy Subcutaneous abdominal adipose tissue (SAAT) biopsy was performed in every participant. Bergström needle was used to obtain samples of subcutaneous fat from paraumbilical area as already described [12]. Biopsy was performed at fasting conditions. About 300 mg of wet weight was obtained. The sample was immediately microdissected, weighed, divided for respective analyses and snap-frozen in liquid nitrogen and stored in -80oC until analyses.
Quantitative real time PCR (RT-qPCR) Total RNA from tissues was isolated using Lipid Tissue and Fibrous Tissue RNeasy Mini Kits (Qiagen). RNA concentration was measured by Nanodrop1000 (Thermo Fisher Scientific, Wilmington, USA). RNA was treated with DNAse I (Invitrogen, Carlsbad CA, USA) to remove any contaminating genomic DNA. cDNA was prepared from 200- 600 ng of RNA using High Capacity cDNA archive kit (Applied Biosystems, Carlsbad CA, USA). Equivalent of 5 ng of RNA was used for Real Time PCR reactions using Fast Advanced master mix and Gene expression assay (IRS1, GLUT4, BCKDHA, BCKDHB, ACOX, CPT1b, PLIN1, PLIN2, PLIN5, FASN, SCD1, DGAT2, PPAR-γ; Applied Biosystems). All samples were run in duplicates. Gene expression of target genes was normalized to expression of RPS13 (glucuronidase, beta) and fold change of expression was calculated using delta delta Ct method.
Fatty acid spectrum in AT Fatty acid spectrum in AT was assessed using gas chromatography, a method already described by Lepage and Roy [13] with modifications by Rodriguez-Palmero et al. [14] In brief, the method involves a chloroform/methanol extraction of freeze-dried AT to isolate lipids and subsequent transesterification or esterification of FA bound to lipids to form methyl esters, which were then analyzed using gas chromatography.
Statistical analysis Data are presented in text, tables, and figures as means ± SD with 95 % CI and p-values <0.05 were considered statistically significant. Student t-test was used in observational samples for normally distributed data. Wilcoxon matched pairs test was used when data were not normally distributed. Intervention samples were compared using a general linear model to test the statistical significance of differences between groups. A mixed model ANOVA was used to assess group × time interaction. Within each group time effects of the intervention were assessed using repeated measures ANOVA with Bonferroni's multiple comparison. Where there were only two data sets within each group (i.e. only baseline and intervention data as in data obtained from tissue biopsies) paired t-tests were used for normally distributed data and Wilcoxon test when data were not normally distributed. Pearson's correlation coefficient was calculated to express relationship between changes from baseline to intervention for normally distributed data and Spearman's correlation coefficient was calculated when data were not normally distributed. Statistica 9.0, StatSoft, Inc. USA was used to perform all statistical procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vegan | Experimental | Dietary Supplement: branched chain amino acidsVegan subjects interveinted with oral capsules of BCAA, 15 (women) or 20 (men) grams daily for 3 months |
| omnivor | Active comparator | Dietary Supplement: branched chain amino acidsOmnivorous subjects iterveined with oral capsules of BCAA, 15 (women) or 20 (men) grams daily for 3 months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| branched chain amino acids15 (women) or 20 (men) grams of BCAA daily for 3 months | Dietary supplement | omnivor, vegan |
Primary outcome
Change in glucose disposal
Time frame: Change from baseline to 3 months (intervention) and to 9 months (after wash-out )
glucose clamp technique; summarized in methods elsewhere
3 secondary outcomes
Change in electron transport chain enzymes and citrate synthase activity
Time frame: Change from baseline to 3 months (intervention)
Change in gene expression in skeletal muscle
Time frame: Change from baseline to 3 months (intervention)
Change in gene expression in adipose tissue
Time frame: Change from baseline to 3 months (intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Background: PubMed 7137077Baecke JA, Burema J, Frijters JE. A short questionnaire for the measurement of habitual physical activity in epidemiological studies. Am J Clin Nutr. 1982 Nov;36(5):936-42. doi: 10.1093/ajcn/36.5.936.
- Background: PubMed 16583097Florindo AA, Latorre Mdo R, Santos EC, Negrao CE, Azevedo LF, Segurado AA. Validity and reliability of the Baecke questionnaire for the evaluation of habitual physical activity among people living with HIV/AIDS. Cad Saude Publica. 2006 Mar;22(3):535-41. doi: 10.1590/s0102-311x2006000300008. Epub 2006 Mar 27.
- Background: PubMed 24677638Tuma P. Rapid determination of globin chains in red blood cells by capillary electrophoresis using INSTCoated fused-silica capillary. J Sep Sci. 2014 Apr;37(8):1026-32. doi: 10.1002/jssc.201400044. Epub 2014 Mar 13.
- Background: PubMed 25639649Tuma 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.
- Background: PubMed 382871DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
- Background: PubMed 783201Palmer JP, Benson JW, Walter RM, Ensinck JW. Arginine-stimulated acute phase of insulin and glucagon secretion in diabetic subjects. J Clin Invest. 1976 Sep;58(3):565-70. doi: 10.1172/JCI108502.
- Background: PubMed 1108172Bergstrom J. Percutaneous needle biopsy of skeletal muscle in physiological and clinical research. Scand J Clin Lab Invest. 1975 Nov;35(7):609-16. No abstract available.
- Background: PubMed 22653162Spinazzi M, Casarin A, Pertegato V, Salviati L, Angelini C. Assessment of mitochondrial respiratory chain enzymatic activities on tissues and cultured cells. Nat Protoc. 2012 May 31;7(6):1235-46. doi: 10.1038/nprot.2012.058.
- Background: PubMed 17332151Janssen AJ, Trijbels FJ, Sengers RC, Smeitink JA, van den Heuvel LP, Wintjes LT, Stoltenborg-Hogenkamp BJ, Rodenburg RJ. Spectrophotometric assay for complex I of the respiratory chain in tissue samples and cultured fibroblasts. Clin Chem. 2007 Apr;53(4):729-34. doi: 10.1373/clinchem.2006.078873. Epub 2007 Mar 1.
- Background: PubMed 14832284COOPERSTEIN SJ, LAZAROW A. A microspectrophotometric method for the determination of cytochrome oxidase. J Biol Chem. 1951 Apr;189(2):665-70. No abstract available.
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- Individual participant dataSharing planned: Yes
Related trials for Type 2 Diabetes Mellitus With Features of Insulin Resistance
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ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome
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NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of ACHETA DOMESTICUS POWDER CONSUMPTION on GLUCOSE HOMEOSTASIS and INTESTINAL DYSBIOSIS in HEALTHY and PREDIABETIC POPULATION.
Insulin Resistance, Type 2 Diabetes Mellitus with Features of Insulin Resistance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Anděl, Prof., MD principal investigator
3rd Faculty of Medicine, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing branched chain amino acids in people with Type 2 Diabetes Mellitus With Features of Insulin Resistance, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose disposal (time frame: Change from baseline to 3 months (intervention) and to 9 months (after wash-out )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02684929, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.