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Elderly Individuals Aged 60 Years or OlderNCT06604390

THE EFFECTS OF GAMBIR CATECHIN (UNCARIA GAMBIR ROXB) SUPPLEMENTATION ON COGNITIVE FUNCTION, EXPRESSION OF APP, MAPT, BDNF, IL-10, TGF-Β GENES, AND PLASMA MDA LEVELS IN THE ELDERLY.

A study testing catechin extracts (health food) and plasebo in people with Elderly Individuals Aged 60 Years or Older and Mild Cognitive Impairment (MCI), run by Rahmi Novita Yusuf at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective The primary objective of this clinical trial is to investigate the effects of gambir catechin administration on cognitive function, the expression of amyloid precursor protein (APP), microtubule-associated protein tau (MAPT), brain-derived neurotrophic factor (BDNF), interleukin-10 (IL-10), transforming… Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
What is being tested?
catechin extracts (health food) and plasebo
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
2 sitesin 2 countries
Study dates
1 Feb 2024to 15 Aug 2024
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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 60 years and above
  • Mild cognitive impairment (MoCA-INA score of 20-25)
  • No history of neurological or psychiatric disorders
  • No history of substance abuse or chronic medical conditions that may interfere with cognitive function
  • Willingness to participate in the study and provide informed consent

Who cannot join

  • Participants who did not take Catechin Capsules for two days in a row

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Fiji1 site

  • Andalas Univercity

    Padang, West Sumatera, 25126

Indonesia1 site

  • Andalas Univercity

    Padang, West Sumatera, 25163

Other trials in Indonesia

About this study

Official title: THE EFFECTS OF GAMBIR CATECHIN (UNCARIA GAMBIR ROXB) SUPPLEMENTATION ON COGNITIVE FUNCTION, EXPRESSION OF AMYLOID PRECURSOR PROTEIN (APP), MICROTUBULE ASSOCIATED PROTEIN TAU (MAPT), BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF), INTERLEUKIN 10 (IL-10), TRANSFORMING GROWTH FACTOR-BETA (TGF-BETA), AND PLASMA MALONDIALDEHYDE (MDA) LEVELS IN THE ELDERLY

Objective The primary objective of this clinical trial is to investigate the effects of gambir catechin administration on cognitive function, the expression of amyloid precursor protein (APP), microtubule-associated protein tau (MAPT), brain-derived neurotrophic factor (BDNF), interleukin-10 (IL-10), transforming growth factor beta (TGF-beta), and plasma malondialdehyde (MDA) levels in elderly individuals.

Research Questions

Read more

The primary research questions to be addressed in this study are as follows:

  1. Does the administration of gambir catechin (Uncaria gambir Roxb) improve cognitive function as measured by the Montreal Cognitive Assessment-Indonesia (MoCA-INA) in the elderly after 12 weeks of intervention?
  2. Does the administration of gambir catechin (Uncaria gambir Roxb) affect the expression of APP, MAPT, BDNF, IL-10, and TGF-beta genes in the elderly after 12 weeks of intervention?
  3. Does the administration of gambir catechin (Uncaria gambir Roxb) influence plasma MDA levels in the elderly after 12 weeks of intervention? Methodology

To answer these questions, researchers will compare the effects of gambir catechin with a placebo (an inert substance). This double-blind, randomized controlled trial will involve:

  • Participant Recruitment: Elderly individuals will be recruited and randomly assigned to either the gambir catechin or placebo group.
  • Intervention: Participants will receive daily doses of gambir catechin or a placebo for 12 weeks.
  • Assessments: Cognitive function, gene expression, and plasma MDA levels will be assessed at baseline and after 12 weeks of intervention.
  • Data Analysis: The collected data will be analyzed using appropriate statistical methods to determine the effects of gambir catechin.

Participant Involvement

Participants will be required to:

  • Consume the assigned supplement (gambir catechin or placebo) daily.
  • Attend regular follow-up visits at the research center.
  • Report any adverse events or changes in their health during the study period.
Read the detailed description

Effects of Gambier Catechin (Uncaria gambir Roxb) Supplementation on Cognitive Function, APP, MAPT, BDNF, IL-10, TGF-β Gene Expression, and Plasma MDA Levels in the Elderly

  1. Background Problem: The increasing prevalence of mild cognitive impairment among the elderly and its impact on their quality of life. Research Gap: A lack of research on the utilization of local plants, specifically catechin, an active compound found in gambier leaves, which possesses antioxidant and anti-inflammatory properties and may enhance cognitive function in the elderly population in Indonesia. Research Objective: To investigate the effects of gambier catechin (Uncaria gambir Roxb) supplementation on cognitive function, APP, MAPT, BDNF, IL-10, TGF-β gene expression, and plasma MDA levels in the elderly.
  2. Hypothesis
  3. There is an effect of gambier catechin (Uncaria gambir Roxb) supplementation on improving cognitive function as measured by the MoCA-INA test in the elderly after 12 weeks of supplementation.
  4. There is an effect of gambier catechin (Uncaria gambir Roxb) supplementation on decreasing the expression of APP, MAPT, TGF-β genes and increasing the expression of BDNF, IL-10 genes in the elderly after 12 weeks of supplementation.
  5. There is an effect of gambier catechin (Uncaria gambir Roxb) supplementation on decreasing plasma MDA levels in the elderly after 12 weeks of supplementation.
  6. Research Method Research Design: A randomized controlled trial (RCT) design will be used. Population and Sample:The target population for this study is the elderly aged 60 years and above with mild cognitive impairment (MoCA-INA score of 20-25) residing in Padang City, West Sumatra, Indonesia.
  7. Research Procedure
  8. Recruitment and Screening
  9. Participants will be recruited from community centers, senior citizen clubs, and public health facilities in Padang City.
  10. Eligibility criteria will include:
  11. Age 60 years and above
  12. Mild cognitive impairment (MoCA-INA score of 20-25)
  13. No history of neurological or psychiatric disorders
  14. No history of substance abuse or chronic medical conditions that may interfere with cognitive function
  15. Willingness to participate in the study and provide informed consent
  16. Baseline Assessments <!-- -->
  17. Demographic information will be collected.
  18. Cognitive function will be assessed using the Montreal Cognitive Assessment-Indonesia (MoCA-INA) test.
  19. Blood samples will be drawn for biochemical analysis, including plasma MDA levels.
  20. Genetic analysis will be conducted to assess the expression of APP, MAPT, BDNF, IL-10, and TGF-β genes.
  21. Intervention
  22. Participants will be randomly assigned to either the intervention or control group.
  23. The intervention group will receive gambier catechin supplementation (Uncaria gambir Roxb) at a daily dose of [Insert dosage] for 12 weeks.
  24. The control group will receive a placebo. d. Follow-up Assessments <!-- -->
  25. Cognitive function will be reassessed using the MoCA-INA test at 12 weeks.
  26. Blood samples will be drawn for biochemical analysis and genetic analysis as described in the baseline assessments.
  27. Data Analysis
  28. Descriptive statistics will be used to summarize demographic data, cognitive function scores, and biochemical parameters.
  29. Inferential statistics, including t-tests and ANOVA, will be used to compare the differences between the intervention and control groups.
  30. Correlation analysis will be conducted to examine the relationship between cognitive function, genetic expression, and plasma MDA levels.
  31. Ethical Considerations
  32. The study will be conducted in accordance with ethical principles and guidelines, including the Declaration of Helsinki.
  33. Informed consent will be obtained from all participants.
  34. Participant confidentiality will be maintained throughout the study.
  35. Any adverse events will be monitored and reported.
Being tested
catechin extracts (health food), plasebo
Keywords
Catechin, Cognitive function, cognitive funtion
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • catechin extracts (health food)Dietary supplement

    Type of intervention:

    1. Purified gambir ≥ 90% (+)-Catechin
    2. Dosage of 224 mg catechin capsule, once daily
    3. Dosage of 224 mg placebo capsule, once daily
    4. Cognitive function was assessed using MoCA-Ina and gene markers APP, MAPT, BDNF, IL-10, TGF-Beta and MDA Plasma.\&#34;

  • plaseboOther

    Dosage of 224 mg placebo per capsule, once daily. Cognitive function was assessed using the MoCA-Ina and biomarkers including APP, MAPT, BDNF, IL-10, TGF-Beta, and plasma MDA.

Study groups in NCT06604390
Study groupRoleWhat they receive
Arm 1: Catechin Group Arm 2: Placebo GroupPlacebo comparatorArm 1: Catechin Group. Participants in this group received one capsule of gambir catechin daily, with a dosage of 224 mg. Arm 2: Placebo Group. Participants in this group received one placebo capsule daily, with a dosage of 224 mg.
Receives: Dietary Supplement: catechin extracts (health food); Other: plasebo
Effects of Gambier Catechin Supplementation on Cognitive Function, APP, MAPT,ExperimentalGambir purified with a minimum of 90% (+)-Catechin content. Dosage of 224 mg catechin per capsule, once daily.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the effect of gambir catechin (Uncaria gambir Roxb) supplementation on cognitive function using the MoCA-INA test in the elderly after 12 weeks of supplementation

    scor MoCA: 20 to 25

    Measured: April to september 2024 ( 6 month)

  2. To determine the effect of gambir catechin (Uncaria gambir Roxb) supplementation on the expression of APP, MAPT, BDNF, IL-10, and TGF-β genes in the elderly after 12 weeks of supplementation.

    Gene expression was measured using PCR

    Measured: April to september 2024 ( 6 month)

  3. To determine the effect of gambir catechin (Uncaria gambir Roxb) supplementation on plasma MDA levels in the elderly after 12 weeks of supplementation.

    Plasma MDA levels, as a marker of lipid peroxidation, were measured using a UV-vis spectrophotometer and the TBARS assay

    Measured: April to september 2024 ( 6 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Feb 2024
  3. Primary completion6 Aug 2024
  4. Study completion15 Aug 2024

Resources

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
Objective: This clinical trial aims to investigate the effects of gambir catechin supplementation on cognitive function, and plasma levels of APP, MAPT, BDNF, IL-10, TGF-beta, and MDA in the elderly. Research Design: A randomized controlled trial (RCT) design will be used. Population and Sample:The target population for this study is the elderly aged 60 years and above with mild cognitive impairment (MoCA-INA score of 20-25) residing in Padang City, West Sumatra, Indonesia. Intervention 1. Participants will be randomly assigned to either the intervention or control group. 2. The intervention group will receive gambier catechin supplementation (Uncaria gambir Roxb) at a daily dose of \[224 mg\] for 12 weeks. 3. The control group will receive a placebo.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06604390
Sponsor's protocol ID
115/UN.16.2/KEP-FK/2024
Other IDs
TheResearchEthicsCommittee Fac
Status last verified
Sep 2024
First submitted
12 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baba Y, Kaneko T, Takihara T. Matcha consumption maintains attentional function following a mild acute psychological stress without affecting a feeling of fatigue: A randomized placebo-controlled study in young adults. Nutr Res. 2021 Apr;88:44-52. doi: 10.1016/j.nutres.2020.12.024. Epub 2021 Jan 2.

    PubMed 33744591

  • Baba Y, Inagaki S, Nakagawa S, Kaneko T, Kobayashi M, Takihara T. Effects of l-Theanine on Cognitive Function in Middle-Aged and Older Subjects: A Randomized Placebo-Controlled Study. J Med Food. 2021 Apr;24(4):333-341. doi: 10.1089/jmf.2020.4803. Epub 2021 Mar 22.

    PubMed 33751906

  • Ide K, Yamada H, Takuma N, Kawasaki Y, Harada S, Nakase J, Ukawa Y, Sagesaka YM. Effects of green tea consumption on cognitive dysfunction in an elderly population: a randomized placebo-controlled study. Nutr J. 2016 May 4;15(1):49. doi: 10.1186/s12937-016-0168-7.

    PubMed 27142448

  • Baba Y, Inagaki S, Nakagawa S, Kaneko T, Kobayashi M, Takihara T. Effect of Daily Intake of Green Tea Catechins on Cognitive Function in Middle-Aged and Older Subjects: A Randomized, Placebo-Controlled Study. Molecules. 2020 Sep 17;25(18):4265. doi: 10.3390/molecules25184265.

    PubMed 32957612

Questions about this trial

What is this clinical trial studying?

A study testing catechin extracts (health food) and plasebo in people with Elderly Individuals Aged 60 Years or Older and Mild Cognitive Impairment (MCI), run by Rahmi Novita Yusuf at 2 sites in 2 countries.

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 5 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Fiji, Indonesia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the effect of gambir catechin (Uncaria gambir Roxb) supplementation on cognitive function using the MoCA-INA test in the elderly after 12 weeks of supplementation (time frame: April to september 2024 ( 6 month)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06604390, which also lists 4 linked publications.

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 19 Sep 2024.

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