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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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenic Obesity focused on measuring Sarcopenic Obesity, Aging, Taurine, Multicomponent Training, Metabolomics

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    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
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    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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