Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training
Primary Purpose
Sarcopenic Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Taurine and Exercise (Tau+Ex)
Placebo and Exercise (PL+Ex)
Taurine (Tau)
Placebo (PL)
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenic Obesity focused on measuring Sarcopenic Obesity, Aging, Taurine, Multicomponent Training, Metabolomics
Eligibility Criteria
Inclusion Criteria:
- BMI between 30 and 40kg/m²;
- Appendicular lean mass below 15 kg;
- Dynamometry below the cutoff point adjusted for sex and BMI (less than or equal to 21kg);
- "Sit and stand" test below the cut-off point adjusted for the age group, considering the number of repetitions in 30 seconds;
- Present medical certificate to perform physical exercise
Exclusion Criteria:
- alcoholics
- smokers;
- with any disease that prevents the practice of physical activity;
- medical impediment to the practice of physical exercise throughout the study;
- infectious diseases;
- coronary diseases;
- chronic kidney diseases;
- undergoing nutritional monitoring or weight loss treatment;
- score ≤13 for cognitive screening on the Mini-Mental State Examination (MMSE), suggested by Bertolucci et al. (1994).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Taurine and Exercise (Tau+Ex)
Placebo and Exercise (PL+Ex)
Taurine (Tau)
Placebo (PL)
Arm Description
Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks.
Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks.
Participants who will receive 3g of taurine supplementation in the period of 16 weeks.
Participants who will receive 3g of placebo supplementation in the period of 16 weeks.
Outcomes
Primary Outcome Measures
Metabolomic Profile
Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.
Secondary Outcome Measures
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers.
Changes in the expression of genes related to the inflammatory process that will be analyzed: C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-15 (IL-15), necrosis factor tumor-α (TNF-α), nuclear factor-κβ (NFκβ) and adiponectin (ADIPOQ).
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers.
Changes in the expression of genes related to oxidative stress that will be analyzed: superoxide dismutase (SOD1), glutathione peroxidase (GPx1) and catalase (CAT).
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers.
Changes expression of genes related to the lipid oxidation process that will be analyzed: sirtuin-1 (SIRT-1), forkhead O 1 (FOXO1), peroxisome proliferator 1 alpha (PGC-1α), peroxisomal proliferator alpha type (PPARα).
Functional ability tests: Six-minute walk test (minutes)
Changes in functional capacity assessed by: six-minute walk test.
Functional ability tests: forearm flexion test (seconds)
Changes in functional capacity assessed by: forearm flexion test.
Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)
Changes in functional capacity assessed by: muscle strength (dynamometer).
Functional ability tests: chair sit-up test. (seconds)
Changes in functional capacity assessed by: chair sit-up test.
Indirect calorimetry assessment
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Body composition changes (%)
Changes in % fat-free mass and fat mass evaluated pre, during and post intervention by iDEXA.
Anthropometric measurements (Body weight)
Changes in body weight (kilograms - Kg) pre and post intervention.
Anthropometric - height assessment (meters)
Height measured in meters
Anthropometric measurements (Circumferences)
Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
Others changes in metabolic parameters
Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-c, fasting glucose and insulin sensitivity evaluated pre and post intervention.
Food Intake changes
Changes in food consumption. It will be evaluated through 24-hour food records. The professional software Dietbox will be used to evaluate the total consumption of energy and macronutrients. Evaluated pre, during and post intervention.
Changes in Plasma Taurine Concentration
Changes in Plasma Taurine Concentration. Plasma taurine will be determined by high performance liquid chromatography (HPLC).
Full Information
NCT ID
NCT05437952
First Posted
June 16, 2022
Last Updated
June 23, 2022
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05437952
Brief Title
Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training
Official Title
Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training in Elderly Women With Sarcopenic Obesity Using the Metabolomics Approach
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. Therefore, the present study seeks to investigate whether taurine supplementation associated with exercise is able to promote contributions to the metabolic profile, through a metabolomics approach, in elderly women with sarcopenic obesity.
Detailed Description
Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. The study will involve 60 elderly women with sarcopenic obesity who will be randomly distributed into 4 groups: 1) GPL, submitted to placebo supplementation (n=15); 2) GTAU, submitted to taurine supplementation (n=15); 3) GPL+EX, submitted to placebo supplementation associated with physical exercise (n=15) and 4) GTAU+EX, submitted to taurine supplementation associated with physical exercise (n=15). The interventions will take place for 16 weeks, collections and evaluations will be carried out pre and post-intervention of functional capacity testing, anthropometry, resting energy expenditure, biopsy of white adipose tissue for analysis of gene expression and blood collection for analysis of the plasma concentration of taurine and of the metabolomic profile. Body composition, and food consumption will be evaluated pre, during and post-intervention. The synergistic effects of the proposed intervention are expected to improve the metabolic parameters, regarding the profile anti-inflammatory, antioxidant, lipid metabolism, body composition, and functional physical capacity in elderly women with sarcopenic obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenic Obesity
Keywords
Sarcopenic Obesity, Aging, Taurine, Multicomponent Training, Metabolomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind clinical trial
Masking
ParticipantInvestigator
Masking Description
The study will involve 60 elderly women with sarcopenic obesity who will be randomly distributed into 4 groups: 1) GPL, submitted to placebo supplementation (n=15); 2) GTAU, submitted to taurine supplementation (n=15); 3) GPL+EX, submitted to placebo supplementation associated with physical exercise (n=15) and 4) GTAU+EX, submitted to taurine supplementation associated with physical exercise (n=15).
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Taurine and Exercise (Tau+Ex)
Arm Type
Experimental
Arm Description
Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks.
Arm Title
Placebo and Exercise (PL+Ex)
Arm Type
Experimental
Arm Description
Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks.
Arm Title
Taurine (Tau)
Arm Type
Experimental
Arm Description
Participants who will receive 3g of taurine supplementation in the period of 16 weeks.
Arm Title
Placebo (PL)
Arm Type
Placebo Comparator
Arm Description
Participants who will receive 3g of placebo supplementation in the period of 16 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Taurine and Exercise (Tau+Ex)
Intervention Description
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Pshysical exercise
Participants will perform a multicomponent type workout that explores strength, aerobic and balance capacities with load progression every 15 days. The sessions will last 60 minutes each, being held three times a week with a day of rest in between. The intervention will last 16 weeks
Intervention Type
Other
Intervention Name(s)
Placebo and Exercise (PL+Ex)
Intervention Description
Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Pshysical exercise
Participants will perform a multicomponent type workout that explores strength, aerobic and balance capacities with load progression every 15 days. The sessions will last 60 minutes each, being held three times a week with a day of rest in between. The intervention will last 16 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Taurine (Tau)
Intervention Description
Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo (PL)
Intervention Description
Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Primary Outcome Measure Information:
Title
Metabolomic Profile
Description
Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers.
Description
Changes in the expression of genes related to the inflammatory process that will be analyzed: C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-15 (IL-15), necrosis factor tumor-α (TNF-α), nuclear factor-κβ (NFκβ) and adiponectin (ADIPOQ).
Time Frame
16 weeks
Title
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers.
Description
Changes in the expression of genes related to oxidative stress that will be analyzed: superoxide dismutase (SOD1), glutathione peroxidase (GPx1) and catalase (CAT).
Time Frame
16 weeks
Title
Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers.
Description
Changes expression of genes related to the lipid oxidation process that will be analyzed: sirtuin-1 (SIRT-1), forkhead O 1 (FOXO1), peroxisome proliferator 1 alpha (PGC-1α), peroxisomal proliferator alpha type (PPARα).
Time Frame
16 weeks
Title
Functional ability tests: Six-minute walk test (minutes)
Description
Changes in functional capacity assessed by: six-minute walk test.
Time Frame
16 weeks
Title
Functional ability tests: forearm flexion test (seconds)
Description
Changes in functional capacity assessed by: forearm flexion test.
Time Frame
16 weeks
Title
Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)
Description
Changes in functional capacity assessed by: muscle strength (dynamometer).
Time Frame
16 weeks
Title
Functional ability tests: chair sit-up test. (seconds)
Description
Changes in functional capacity assessed by: chair sit-up test.
Time Frame
16 weeks
Title
Indirect calorimetry assessment
Description
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Time Frame
16 weeks
Title
Body composition changes (%)
Description
Changes in % fat-free mass and fat mass evaluated pre, during and post intervention by iDEXA.
Time Frame
16 weeks
Title
Anthropometric measurements (Body weight)
Description
Changes in body weight (kilograms - Kg) pre and post intervention.
Time Frame
16 weeks
Title
Anthropometric - height assessment (meters)
Description
Height measured in meters
Time Frame
16 weeks
Title
Anthropometric measurements (Circumferences)
Description
Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
Time Frame
16 weeks
Title
Others changes in metabolic parameters
Description
Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-c, fasting glucose and insulin sensitivity evaluated pre and post intervention.
Time Frame
16 weeks
Title
Food Intake changes
Description
Changes in food consumption. It will be evaluated through 24-hour food records. The professional software Dietbox will be used to evaluate the total consumption of energy and macronutrients. Evaluated pre, during and post intervention.
Time Frame
16 weeks
Title
Changes in Plasma Taurine Concentration
Description
Changes in Plasma Taurine Concentration. Plasma taurine will be determined by high performance liquid chromatography (HPLC).
Time Frame
16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI between 30 and 40kg/m²;
Appendicular lean mass below 15 kg;
Dynamometry below the cutoff point adjusted for sex and BMI (less than or equal to 21kg);
"Sit and stand" test below the cut-off point adjusted for the age group, considering the number of repetitions in 30 seconds;
Present medical certificate to perform physical exercise
Exclusion Criteria:
alcoholics
smokers;
with any disease that prevents the practice of physical activity;
medical impediment to the practice of physical exercise throughout the study;
infectious diseases;
coronary diseases;
chronic kidney diseases;
undergoing nutritional monitoring or weight loss treatment;
score ≤13 for cognitive screening on the Mini-Mental State Examination (MMSE), suggested by Bertolucci et al. (1994).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela F Abud, M.Sc.
Phone
+5516997940181
Email
gabriela.abud@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen C de Freitas, Ph.D.
Organizational Affiliation
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training
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