Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604390
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 SampleThe 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
-- --
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
-- --
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
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 SampleThe 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
-- --
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
-- --
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None