Effect of Green Tea Supplementation in Older Adult Women

NCT ID: NCT06289439

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2025-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Green tea supplementation group

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

Group Type: EXPERIMENTAL

Green tea (Camellia sinensis) 1000 mg as extract

Intervention Type: 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))

Placebo supplementation group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Green tea (Camellia sinensis) 1000 mg as extract

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))

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. Functional limitation using the Barthel scale (less than 100 = maximum score) and the Lawton-Brody scale (less than 8 = maximum value).

2. Acute/chronic heart failure with NYHA (New York Heart Association) scale >II.

3. Uncontrolled hypertension (>180/100 mm Hg).

4. Uncontrolled orthostatic hypotension.

5. Uncontrolled atrial or ventricular arrhythmias, aortic dissecting aneurysm, severe aortic stenosis, acute endocarditis/pericarditis.

6. Recent acute myocardial infarction (3 to 6 months) or unstable angina.

7. Acute thromboembolic disease.

8. Acute/chronic respiratory failure.

9. Moderate/severe chronic obstructive pulmonary disease (COPD) with Bodex index C or D.

10. Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.

11. Recent bone fracture (last month).

12. History of dementia (suspected by the MAP environment and diagnosed).

13. Previous supplementation with amino acids or other nutritional compounds to improve physical performance.

14. Any other circumstance that your doctor considers prevents physical activity.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sanidad de Castilla y León

OTHER

Sponsor Role: collaborator

Instituto de Neurociencia de Castillas y Leon

OTHER

Sponsor Role: collaborator

University of Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Diego Fernandez Lazaro

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Health Sciences, University of Valladolid Soria Campus

Soria, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Diego Fernández Lázaro, Professor; PhD

Role: CONTACT

diego.fernandez.lazaro@uva.es

+34658073375

César Ignacio Fernández Lázaro, Professor; PhD

Role: CONTACT

fernandezlazaro@usal.es

658073375

Facility Contacts

Diego Fernández Lázaro, Vice Dean

Role: primary

diego.fernandez.lazaro@uva.es

+34658073375

Other Identifiers

2024.05.25

Identifier Type: -

Identifier Source: org_study_id