Effect of Green Tea Supplementation in Older Adult Women

NCT06289439 | Recruiting

• 1 other identifier: 2024.05.25
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: One of the consequences of aging is the decrease in physical performance which can affect the quality of life of older people. Although physical exercise is beneficial in improving this problem, older women do not seem to benefit as much as men. In this sense, the use of ergonomic aids by women could compensate for these issues. Thus, green tea has shown beneficial effects on physical performance in athletes through, among others, improving blood flow and vasodilation, mitochondrial respiration, calcium management, glucose and amino acid uptake, lipid oxidation, modulation of muscle damage, antioxidant effect, and anabolic and catabolic hormones, activation of the hypothalamic-pituitary-adrenal axis, etc. Therefore, the deterioration of physical performance and quality of life of green tea. Objective: To analyze the effect of supplementation with 1 g/day green tea extract (500 mg of polyphenols) for 10 weeks on quality of life values, physical performance (grip strength, walking speed, and resistance), and health biomarkers (biochemical, hematological, and hormonal) in women over 60 years of age who follow a physical training program. Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.9±4.58 years, BMI: 25.09±3.24 and body fat percentage: 32.54±6.39) who followed a physical activity adapted to their age and abilities are the members of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 1 g/day of green tea (GI; n = 10). Different physical tests were performed (grip strength, walking speed and resistance) and the quality of life questionnaire (WHOQOL-BREF) was passed and health biomarkers (biochemical, hematological, and hormonal) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2).

Conditions

Female; Older Adults; Sarcopenia

Keywords

sarcopenia; green tea; exercise; quality of life; physical performance; health biomarkers

Outcome Measures

Primary Outcomes (2)

• Creatine kinase (CK)

  CK is an enzyme expressed by various tissues and cell types; markers of muscle damage

  first day of study and after 30 days of supplementation (end of study)

• Lactate dehydrogenase (LDH)

  LDH is a catalytic enzyme found in many tissues of the body;markers of muscle damage

  first day of study and after 30 days of supplementation (end of study)

Secondary Outcomes (15)

• Myoglobin (Mb)

  1st and 30th days of the trial

• Alanine Aminotransferase (ALT)

  1st and 30th days of the trial

• Aspartate Aminotransferase (AST)

  1st and 30th days of the trial

• Interleukin 6 (IL-6)

  1st and 30th days of the trial

• C-reactive protein (PCR)

  1st and 30th days of the trial

Study Arms (2)

Green tea supplementation group

EXPERIMENTAL

2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal

Dietary Supplement: Green tea (Camellia sinensis) 1000 mg as extract

Placebo supplementation group

PLACEBO COMPARATOR

2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal

Other: Placebo

Interventions

Green tea (Camellia sinensis) 1000 mg as extract DIETARY_SUPPLEMENT

Two capsules per day; Each capsule includes Green Tea Leaf (Camellia sinensis) 5000 mg composed of 500 mg of green tea extract and 250 mg of polyphenols (epicatechin (EC), epigallocatechin (EGC), epicatechin gallato (ECG), and epigallocatechin gallato (EGCG))

Green tea supplementation group

Placebo OTHER

Two capsules per day; Each capsule includes 100-mg maltodextrin capsules were used as a placebo to match the color and texture of the Green tea tablets to ensure blinding.

Placebo supplementation group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Gender Eligibility Details: Older adult women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adult women between 60 and 80 years old, with the ability to carry out a physical activity program adapted to their age and health condition.

You may not qualify if:

• Functional limitation using the Barthel scale (less than 100 = maximum score) and the Lawton-Brody scale (less than 8 = maximum value).
• Acute/chronic heart failure with NYHA (New York Heart Association) scale \>II.
• Uncontrolled hypertension (\>180/100 mm Hg).
• Uncontrolled orthostatic hypotension.
• Uncontrolled atrial or ventricular arrhythmias, aortic dissecting aneurysm, severe aortic stenosis, acute endocarditis/pericarditis.
• Recent acute myocardial infarction (3 to 6 months) or unstable angina.
• Acute thromboembolic disease.
• Acute/chronic respiratory failure.
• Moderate/severe chronic obstructive pulmonary disease (COPD) with Bodex index C or D.
• Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
• Recent bone fracture (last month).
• History of dementia (suspected by the MAP environment and diagnosed).
• Previous supplementation with amino acids or other nutritional compounds to improve physical performance.
• Any other circumstance that your doctor considers prevents physical activity.

Sponsors & Collaborators

• University of Valladolid: lead
• Sanidad de Castilla y León: collaborator
• Instituto de Neurociencia de Castillas y Leon: collaborator

Study Sites (1)

Faculty of Health Sciences, University of Valladolid Soria Campus

Soria, 42004, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Tea

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Diego Fernández Lázaro, Professor; PhD

CONTACT

+34658073375; diego.fernandez.lazaro@uva.es

César Ignacio Fernández Lázaro, Professor; PhD

CONTACT

658073375; fernandezlazaro@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: Parallel group placebo-controlled randomized clinical trial

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: March 5, 2024
• Primary Completion: December 20, 2024
• Study Completion: April 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

ES (1)