Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenic Obesity
• Intervention / Treatment: Dietary supplement: Taurine and Exercise (Tau+Ex); Other: Placebo and Exercise (PL+Ex); Dietary supplement: Taurine (Tau); Other: Placebo (PL)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriela F Abud, M.Sc.; Phone Number: +5516997940181; Email: gabriela.abud@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taurine and Exercise (Tau+Ex); Participants who will receive 3g of taurine supplementation associated with physical training in the period of 16 weeks.	Dietary supplement: Taurine and Exercise (Tau+Ex); 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
Experimental: Placebo and Exercise (PL+Ex); Participants who will receive 3g of placebo supplementation associated with physical training in the period of 16 weeks.	Other: Placebo and Exercise (PL+Ex); 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.
Experimental: Taurine (Tau); Participants who will receive 3g of taurine supplementation in the period of 16 weeks.	Dietary supplement: Taurine (Tau); Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.
Placebo Comparator: Placebo (PL); Participants who will receive 3g of placebo supplementation in the period of 16 weeks.	Other: Placebo (PL); Participants will receive 3g of placebo to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolomic Profile	Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	16 weeks
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).	16 weeks
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).	16 weeks
Functional ability tests: Six-minute walk test (minutes)	Changes in functional capacity assessed by: six-minute walk test.	16 weeks
Functional ability tests: forearm flexion test (seconds)	Changes in functional capacity assessed by: forearm flexion test.	16 weeks
Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)	Changes in functional capacity assessed by: muscle strength (dynamometer).	16 weeks
Functional ability tests: chair sit-up test. (seconds)	Changes in functional capacity assessed by: chair sit-up test.	16 weeks
Indirect calorimetry assessment	Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.	16 weeks
Body composition changes (%)	Changes in % fat-free mass and fat mass evaluated pre, during and post intervention by iDEXA.	16 weeks
Anthropometric measurements (Body weight)	Changes in body weight (kilograms - Kg) pre and post intervention.	16 weeks
Anthropometric - height assessment (meters)	Height measured in meters	16 weeks
Anthropometric measurements (Circumferences)	Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.	16 weeks
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.	16 weeks
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.	16 weeks
Changes in Plasma Taurine Concentration	Changes in Plasma Taurine Concentration. Plasma taurine will be determined by high performance liquid chromatography (HPLC).	16 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
• Investigators: Principal Investigator: Ellen C De Freitas, Ph.D., University of São Paulo, School of Physical Education and Sports of Ribeirão Preto

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Metabolomics; Aging; Sarcopenic Obesity; Taurine; Multicomponent Training
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: taurine_training_metabolomics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No