FemaleGTAWNCT06289439
Effect of Green Tea Supplementation in Older Adult Women
A study testing Green tea (Camellia sinensis) 1000 mg as extract in people with Female and Older Adults, run by University of Valladolid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female, Older Adults, Sarcopenia
- What is being tested?
- Green tea (Camellia sinensis) 1000 mg as extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 5 Mar 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences, University of Valladolid Soria Campus
Soria, 42004
Diego Fernández Lázaro, Vice Dean, +34658073375, diego.fernandez.lazaro@uva.es
About this study
Official title: Modulation of Sarcopenia in Older Adult Women by Green Tea Extract
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
- Being tested
- Green tea (Camellia sinensis) 1000 mg as extract, Placebo
- Keywords
- sarcopenia, green tea, exercise, quality of life, physical performance, health biomarkers
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea (Camellia sinensis) 1000 mg as extractDietary 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))
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Green tea supplementation group | Experimental | 2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatine kinase (CK)
CK is an enzyme expressed by various tissues and cell types; markers of muscle damage
Measured: 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
Measured: first day of study and after 30 days of supplementation (end of study)
Secondary outcomes (15)
Myoglobin (Mb)
Mb is a muscle heteroprotein
Measured: 1st and 30th days of the trial
Alanine Aminotransferase (ALT)
markers of liver damage
Measured: 1st and 30th days of the trial
Aspartate Aminotransferase (AST)
markers of liver damage
Measured: 1st and 30th days of the trial
Interleukin 6 (IL-6)
inflammatory marker
Measured: 1st and 30th days of the trial
C-reactive protein (PCR)
inflammatory marker
Measured: 1st and 30th days of the trial
Testosterone
hormonal marker
Measured: 1st and 30th days of the trial
Cortisol
hormonal marker
Measured: 1st and 30th days of the trial
Miostatin (GDF8)
growth factor that limits the growth of muscle tissue
Measured: 1st and 30th days of the trial
advanced oxidation protein products (AOPP)
amino acid oxidation marker
Measured: 1st and 30th days of the trial
lipid peroxidation (LPO)
lipid oxidation marker
Measured: 1st and 30th days of the trial
Oxygen radical absorption (ORAC)
antioxidant strength marker
Measured: 1st and 30th days of the trial
Total antioxidant status (TAS)
antioxidant capacity marker
Measured: 1st and 30th days of the trial
Total antioxidant capacity (TAC)
antioxidant capacity marker
Measured: 1st and 30th days of the trial
Short Physical Performance Battery (SPPB)
Test evaluates three aspects of mobility
Measured: 1st and 30th days of the trial
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
a self-report questionnaire which assesses 4 domains of quality of life (QOL): physical health, psychological health, social relationships, and environment
Measured: 1st and 30th days of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start5 Mar 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group placebo-controlled randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Sanidad de Castilla y León, Instituto de Neurociencia de Castillas y Leon
- Responsible party
- Principal investigator, Diego Fernandez Lazaro, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289439
- Sponsor's protocol ID
- 2024.05.25
- Acronym
- GTAW
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Sarcopenia in Older Adult Women by Green Tea Extract
- ClinicalTrials.gov ID
- NCT06289439
- Acronym / sponsor ID
- GTAW / 2024.05.25
- Conditions
- Female, Older Adults, Sarcopenia
- Keywords
- sarcopenia, green tea, exercise, quality of life, physical performance, health biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Sanidad de Castilla y León, Instituto de Neurociencia de Castillas y Leon
- Study start
- 5 Mar 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group placebo-controlled randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Green tea supplementation group | Experimental | Dietary Supplement: Green tea (Camellia sinensis) 1000 mg as extract2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal |
| Placebo supplementation group | Placebo comparator | Other: Placebo2 capsules for 10 consecutive weeks, distributed in a single daily oral intake with the main meal |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green tea (Camellia sinensis) 1000 mg as extractTwo 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)) | Dietary supplement | Green tea supplementation group |
| PlaceboTwo 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. | Other | Placebo supplementation group |
Primary outcome
Creatine kinase (CK)
Time frame: first day of study and after 30 days of supplementation (end of study)
CK is an enzyme expressed by various tissues and cell types; markers of muscle damage
Lactate dehydrogenase (LDH)
Time frame: first day of study and after 30 days of supplementation (end of study)
LDH is a catalytic enzyme found in many tissues of the body;markers of muscle damage
15 secondary outcomes
Myoglobin (Mb)
Time frame: 1st and 30th days of the trial
Alanine Aminotransferase (ALT)
Time frame: 1st and 30th days of the trial
Aspartate Aminotransferase (AST)
Time frame: 1st and 30th days of the trial
Interleukin 6 (IL-6)
Time frame: 1st and 30th days of the trial
C-reactive protein (PCR)
Time frame: 1st and 30th days of the trial
Testosterone
Time frame: 1st and 30th days of the trial
Cortisol
Time frame: 1st and 30th days of the trial
Miostatin (GDF8)
Time frame: 1st and 30th days of the trial
advanced oxidation protein products (AOPP)
Time frame: 1st and 30th days of the trial
lipid peroxidation (LPO)
Time frame: 1st and 30th days of the trial
Oxygen radical absorption (ORAC)
Time frame: 1st and 30th days of the trial
Total antioxidant status (TAS)
Time frame: 1st and 30th days of the trial
Total antioxidant capacity (TAC)
Time frame: 1st and 30th days of the trial
Short Physical Performance Battery (SPPB)
Time frame: 1st and 30th days of the trial
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: 1st and 30th days of the trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea (Camellia sinensis) 1000 mg as extract in people with Female and Older Adults, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Fernández Lázaro, Professor; PhD (+34658073375, diego.fernandez.lazaro@uva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatine kinase (CK) (time frame: first day of study and after 30 days of supplementation (end of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.