NCT05415176

Brief Summary

The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 8, 2022

Last Update Submit

November 28, 2023

Conditions

Keywords

ObesitySarcopeniaBrite adipose tissueTaurineExercise

Outcome Measures

Primary Outcomes (1)

  • Browning of white adipose tissue

    Changes in the gene and protein expression on the subcutaneous white adipose tissue

    16 weeks

Secondary Outcomes (11)

  • Changes in metabolic parameters - fasting blood glucose

    16 weeks

  • Changes in metabolic parameters - lipid profile

    16 weeks

  • Changes in metabolic parameters - insulin sensitivity

    16 weeks

  • Body composition changes

    16 weeks

  • Improvement of physical performance

    16 weeks

  • +6 more secondary outcomes

Study Arms (4)

Taurine and Exercise (Tau+Exe)

EXPERIMENTAL

Individuals who will receive 3g of taurine supplementation combined with physical training in the period of 16 weeks

Dietary Supplement: Taurine supplementationOther: Pshysical exercise

Taurine (Tau)

EXPERIMENTAL

Individuals who will receive 3g of taurine supplementation

Dietary Supplement: Taurine supplementation

Exercise (Exe)

EXPERIMENTAL

Individuals who will perform a physical training and receive a placebo supplementation in the period of 16 weeks

Other: Pshysical exercise

Placebo (Cont)

PLACEBO COMPARATOR

Individuals who will receive a placebo supplementation in the period of 16 weeks

Other: Placebo control

Interventions

Taurine supplementationDIETARY_SUPPLEMENT

Participants will receive 3g of taurine to be supplemented in the morning in single-dose capsules. The intervention will last 16 weeks.

Taurine (Tau)Taurine and Exercise (Tau+Exe)

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

Exercise (Exe)Taurine and Exercise (Tau+Exe)

The participants will receive a supplementation capsule containing placebo in the morning in single-dose capsules. The intervention will last 16 weeks.

Placebo (Cont)

Eligibility Criteria

Age60 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • alcoholics
  • smokers
  • diseases 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Educação Física e Esporte de Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-907, Brazil

Location

MeSH Terms

Conditions

ObesitySarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalBehavior

Study Officials

  • Ellen C de Freitas, PhD

    University of São Paulo, School of Physical Education and Sports of Ribeirão Preto Ph.D. +55 16 3602-0345 ellenfreitas@usp.br

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 10, 2022

Study Start

February 27, 2023

Primary Completion

September 26, 2023

Study Completion

June 1, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations