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.

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

catechin extracts (health food)

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.\"

OTHER

plasebo

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.

Sponsors & Collaborators

• Andalas University

  collaborator OTHER

• Rahmi Novita Yusuf

  lead OTHER

Principal Investigators

• Nur Indrawati Lipoeto, Profesor · Andalas University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2024-08-06

Completion

2024-08-15

Countries

• Fiji
• Indonesia

Study Locations