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.

NCT06604390 | Completed DMC

• 2 other identifiers: 115/UN.16.2/KEP-FK/2024TheResearchEthicsCommittee Fac
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 2

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:

• 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)

Keywords

Catechin; Cognitive function; cognitive funtion

Outcome Measures

Primary Outcomes (3)

• 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

  scor MoCA: 20 to 25

  April to september 2024 ( 6 month)

• 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.

  Gene expression was measured using PCR

  April to september 2024 ( 6 month)

• To determine the effect of gambir catechin (Uncaria gambir Roxb) supplementation on plasma MDA levels in the elderly after 12 weeks of supplementation.

  Plasma MDA levels, as a marker of lipid peroxidation, were measured using a UV-vis spectrophotometer and the TBARS assay

  April to september 2024 ( 6 month)

Study Arms (2)

Arm 1: Catechin Group Arm 2: Placebo Group

PLACEBO COMPARATOR

Arm 1: Catechin Group. Participants in this group received one capsule of gambir catechin daily, with a dosage of 224 mg. Arm 2: Placebo Group. Participants in this group received one placebo capsule daily, with a dosage of 224 mg.

Dietary Supplement: catechin extracts (health food); Other: plasebo

Effects of Gambier Catechin Supplementation on Cognitive Function, APP, MAPT,

EXPERIMENTAL

Gambir purified with a minimum of 90% (+)-Catechin content. Dosage of 224 mg catechin per capsule, once daily.

Dietary Supplement: catechin extracts (health food); Other: plasebo

Interventions

catechin extracts (health food) DIETARY_SUPPLEMENT

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.\"

Arm 1: Catechin Group Arm 2: Placebo Group; Effects of Gambier Catechin Supplementation on Cognitive Function, APP, MAPT,

plasebo OTHER

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.

Arm 1: Catechin Group Arm 2: Placebo Group; Effects of Gambier Catechin Supplementation on Cognitive Function, APP, MAPT,

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rahmi Novita Yusuf: lead
• Andalas University: collaborator

Study Sites (2)

Andalas Univercity

Padang, West Sumatera, 25126, Fiji

Location

Andalas Univercity

Padang, West Sumatera, 25163, Indonesia

Location

Related Publications (4)

• Baba Y, Kaneko T, Takihara T. Matcha consumption maintains attentional function following a mild acute psychological stress without affecting a feeling of fatigue: A randomized placebo-controlled study in young adults. Nutr Res. 2021 Apr;88:44-52. doi: 10.1016/j.nutres.2020.12.024. Epub 2021 Jan 2.

  PMID: 33744591 BACKGROUND

• Baba Y, Inagaki S, Nakagawa S, Kaneko T, Kobayashi M, Takihara T. Effects of l-Theanine on Cognitive Function in Middle-Aged and Older Subjects: A Randomized Placebo-Controlled Study. J Med Food. 2021 Apr;24(4):333-341. doi: 10.1089/jmf.2020.4803. Epub 2021 Mar 22.

  PMID: 33751906 BACKGROUND

• Ide K, Yamada H, Takuma N, Kawasaki Y, Harada S, Nakase J, Ukawa Y, Sagesaka YM. Effects of green tea consumption on cognitive dysfunction in an elderly population: a randomized placebo-controlled study. Nutr J. 2016 May 4;15(1):49. doi: 10.1186/s12937-016-0168-7.

  PMID: 27142448 BACKGROUND

• Baba Y, Inagaki S, Nakagawa S, Kaneko T, Kobayashi M, Takihara T. Effect of Daily Intake of Green Tea Catechins on Cognitive Function in Middle-Aged and Older Subjects: A Randomized, Placebo-Controlled Study. Molecules. 2020 Sep 17;25(18):4265. doi: 10.3390/molecules25184265.

  PMID: 32957612 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nur Indrawati Lipoeto, Profesor

  Andalas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: February 1, 2024
• Primary Completion: August 6, 2024
• Study Completion: August 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1); FI (1)