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 APP, MAPT, BDNF, IL-10, TGF-Β GENES, AND PLASMA MDA LEVELS IN THE ELDERLY.

NCT ID: NCT06604390 Phase: NA Status: COMPLETED Enrollment: 64 Completion: 2024-08-15

Conditions

Elderly Individuals Aged 60 Years or Older, Mild Cognitive Impairment (MCI)

Interventions

catechin extracts (health food), plasebo

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 duri

Primary Outcome

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

Source

ClinicalTrials.gov