ClinicalTrials.gg
RecruitingNCT06289439GTAWUpdated Mar 5, 2024

Effect of Green Tea Supplementation in Older Adult Women

An interventional study of Green tea (Camellia sinensis) 1000 mg as extract and Placebo in Female, Older Adults and Sarcopenia, sponsored by University of Valladolid. Recruiting at 1 site in Spain. Open to female participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by University of Valladolid · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 99 studies in Sarcopenia with a site in Spain — 33 open to participants now, 40 under way, none of them phase 3. Sarcopenia · Spain.

Planned enrollment
21st of 77
120 · median 72
Started
2024
with 13 others
No phase
70 of 99
26 open now
Primary completion
2024-12
later than 3 of 39 live
Registered
60th of 99
by date

Among the 99 studies in Sarcopenia with a site in Spain, this one is the 21st largest by planned enrollment of the 77 interventional ones that give a count, is one of 14 that started in 2024, is one of 70 with no phase, reaches primary completion later than 3 of the 39 other live ones, and was the 60th registered.

Sarcopenia

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

Browse Sarcopenia studies →

Open to participants now

33 of the 99 studies in Sarcopenia with a site in Spain are open now. Recruiting first, the newest first:

27 more — sign in →

All 33 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 247 Sarcopenia studies recruiting now, 153 (62%) set no upper age limit and 33 (13%) stop at 75 or younger; 9 take children under 18; 65 take healthy volunteers.

This study: 60 Years to 80 Years · female · healthy volunteers too.

The full table on the hub →

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02

Study 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).

03

Conditions studied

  • Female
  • Older Adults
  • Sarcopenia

Keywords

  • sarcopenia
  • green tea
  • exercise
  • quality of life
  • physical performance
  • health biomarkers
04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (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 (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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Green tea supplementation group

    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 comparator
    Placebo supplementation group

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

    Other: Placebo

Interventions

  • 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))

  • OtherPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Creatine kinase (CK)

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

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

  2. Lactate dehydrogenase (LDH)

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

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

Secondary outcomes

  1. Myoglobin (Mb)

    Mb is a muscle heteroprotein

    Time frame: 1st and 30th days of the trial

  2. Alanine Aminotransferase (ALT)

    markers of liver damage

    Time frame: 1st and 30th days of the trial

  3. Aspartate Aminotransferase (AST)

    markers of liver damage

    Time frame: 1st and 30th days of the trial

  4. Interleukin 6 (IL-6)

    inflammatory marker

    Time frame: 1st and 30th days of the trial

  5. C-reactive protein (PCR)

    inflammatory marker

    Time frame: 1st and 30th days of the trial

  6. Testosterone

    hormonal marker

    Time frame: 1st and 30th days of the trial

  7. Cortisol

    hormonal marker

    Time frame: 1st and 30th days of the trial

  8. Miostatin (GDF8)

    growth factor that limits the growth of muscle tissue

    Time frame: 1st and 30th days of the trial

  9. advanced oxidation protein products (AOPP)

    amino acid oxidation marker

    Time frame: 1st and 30th days of the trial

  10. lipid peroxidation (LPO)

    lipid oxidation marker

    Time frame: 1st and 30th days of the trial

  11. Oxygen radical absorption (ORAC)

    antioxidant strength marker

    Time frame: 1st and 30th days of the trial

  12. Total antioxidant status (TAS)

    antioxidant capacity marker

    Time frame: 1st and 30th days of the trial

  13. Total antioxidant capacity (TAC)

    antioxidant capacity marker

    Time frame: 1st and 30th days of the trial

  14. Short Physical Performance Battery (SPPB)

    Test evaluates three aspects of mobility

    Time frame: 1st and 30th days of the trial

  15. 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

    Time frame: 1st and 30th days of the trial

07

Study locations

1 of 1 sites recruiting
  • Faculty of Health Sciences, University of Valladolid Soria Campus
    Soria, 42004, Spain
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2024; primary completion for Dec 2024, 9 months later.

Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 9 months is below that.

Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2024
First posted
Mar 1, 2024
StartEst.
Mar 5, 2024
Primary completionEst.
Dec 20, 2024
CompletionEst.
Apr 1, 2025
Last update
Mar 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06289439
Lead sponsor
University of Valladolid
Collaborators
Sanidad de Castilla y León, Instituto de Neurociencia de Castillas y Leon
Responsible party
Diego Fernandez Lazaro (Professor Doctor, University of Valladolid) — Principal investigator
First posted
Mar 1, 2024
Start date
Mar 5, 2024 (estimated)
Primary completion
Dec 20, 2024 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Mar 5, 2024

Study contacts

Diego Fernández Lázaro, Professor; PhD
Contact
diego.fernandez.lazaro@uva.es
+34658073375
César Ignacio Fernández Lázaro, Professor; PhD
Contact
fernandezlazaro@usal.es
658073375

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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