Fact CheckerSign in

NCT06604390Completed

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.

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
64 (actual)
First submitted
12 Sept 2024
Start date
Feb 2024
Primary completion date
Aug 2024
Lead sponsor
Rahmi Novita Yusuf
NCT number
NCT06604390

What you commit to

  • Study type: Interventional
  • Participants enrolled: 64
  • From Feb 2024 to the primary completion date, Aug 2024
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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

Age in the registry: 60 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Andalas Univercity
Coordinator of this site? Confirm its status
PadangFijiUnknown status
Andalas Univercity
Coordinator of this site? Confirm its status
PadangIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.