Clinical trial NCT06604390: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Individuals Aged 60 Years or Older
Mild Cognitive Impairment (MCI)
Keywords: Catechin
Cognitive function
cognitive funtion
Lead sponsor: Andalas University
Sponsor class: OTHER
Collaborators: name: Andalas University
First posted: 2024-09-19
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 growth factor beta (TGF-beta), and plasma malondialdehyde (MDA) levels in elderly individuals.

Research Questions

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.

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

   1. 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.
   2. 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.
   3. There is an effect of gambier catechin (Uncaria gambir Roxb) supplementation on decreasing plasma MDA levels in the elderly after 12 weeks of supplementation.
3. 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.
4. Research Procedure

   1. Recruitment and Screening

      1. Participants will be recruited from community centers, senior citizen clubs, and public health facilities in Padang City.
      2. Eligibility criteria will include:

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

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   1. Demographic information will be collected.
   2. Cognitive function will be assessed using the Montreal Cognitive Assessment-Indonesia (MoCA-INA) test.
   3. Blood samples will be drawn for biochemical analysis, including plasma MDA levels.
   4. Genetic analysis will be conducted to assess the expression of APP, MAPT, BDNF, IL-10, and TGF-β genes.

   c. 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 \[Insert dosage\] for 12 weeks.
   3. The control group will receive a placebo. d. Follow-up Assessments

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   1. Cognitive function will be reassessed using the MoCA-INA test at 12 weeks.
   2. Blood samples will be drawn for biochemical analysis and genetic analysis as described in the baseline assessments.
5. Data Analysis

   1. Descriptive statistics will be used to summarize demographic data, cognitive function scores, and biochemical parameters.
   2. Inferential statistics, including t-tests and ANOVA, will be used to compare the differences between the intervention and control groups.
   3. Correlation analysis will be conducted to examine the relationship between cognitive function, genetic expression, and plasma MDA levels.
6. Ethical Considerations

   1. The study will be conducted in accordance with ethical principles and guidelines, including the Declaration of Helsinki.
   2. Informed consent will be obtained from all participants.
   3. Participant confidentiality will be maintained throughout the study.
   4. Any adverse events will be monitored and reported.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
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
timeFrame: April to september 2024 ( 6 month)
measure: 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.
timeFrame: April to september 2024 ( 6 month)
measure: To determine the effect of gambir catechin (Uncaria gambir Roxb) supplementation on plasma MDA levels in the elderly after 12 weeks of supplementation.
timeFrame: April to september 2024 ( 6 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Padang
country: Fiji
facility: Andalas Univercity
state: West Sumatera
city: Padang
country: Indonesia
facility: Andalas Univercity
state: West Sumatera
Study officials:
affiliation: Andalas University
name: Nur Indrawati Lipoeto, Profesor
role: PRINCIPAL_INVESTIGATOR
References:
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