Anti-Ageing Health Supplement From Ginger Extracts

Development of Anti-Ageing Health Supplement From Subcritical Water Extraction of Zingiber Officinale Roscoe (Ginger) Bioactive Compounds

This study examines the development and efficacy of a health supplement derived from ginger using water extraction. Designed to address aging-related issues such as muscle loss (sarcopenia) and cognitive decline, the capsule's safety and effectiveness were evaluated through clinical trials. Stability testing ensured the capsules maintained their quality under various environmental conditions. Clinical trials further assessed the supplement's antioxidant and anti-inflammatory properties. The findings support its potential benefits for elderly health and aging-related challenges.

Study Overview

• Status: Completed
• Conditions: Cognitive Decline; Musculoskeletal; Ageing Signs
• Intervention / Treatment: Dietary supplement: ginger extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • WP Kuala Lumpur
    • Cheras, WP Kuala Lumpur, Malaysia, 56000
      • Hospital Canselor Tuanku Muhriz, UKM Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adult male
• Blood chemistry results specifically Blood Urea Nitrogen (BUN), Serum Creatinine, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-glutamyl transpeptidase (GGTP), Total Bilirubin and alkaline phosphatase and urinalysis results, specifically urine pH, protein, glucose, ketone, and bilirubin levels within +/- 20% of normal value indicated in the lab report.
• Individuals are willing to maintain their exercise habits and dietary patterns throughout the trial
• No allergy to ginger
• Provide written informed consent before screening
• Subject is willing and able to comply with the study visit schedule and procedure, geographic proximity (investigator's discretion) that allows adequate follow-up
• Subjects understand the study protocol and sign informed consent forms

Exclusion Criteria:

• Use of dietary supplements within one week of Day 0. Supplements include any ginger (Zingiber officinale, ginger root, black ginger, zingiberis rhizoma) vitamins, minerals, and herbal products, including herbal drinks.
• Presence of, or clinically significant history of, cancer, cardiovascular, endocrine, kidney, liver, lung, gastrointestinal, metabolic disorder, absorption disorder such as Celiac or Crohn's disease and/or any other chronic health condition such as diabetes identified from the findings of the interview.
• Presence of gallstones or history of gallbladder disease.
• Presence or history of diabetes.
• Presence of cardiovascular disease and hypertension with inconsistent medication regimen, unstable conditions, and without proper physician's - Ten hours before the blood and urine sample collection, subjects should refrain from using medications such as statins (e.g., simvastatin, fluvastatin), NSAIDS including paracetamol, aspirin, nitric oxide (eNOS) activators or inhibitors (e.g., selegiline, Viagra), and angiotensin II receptor blocker (e.g., Telmisartan (blood pressure)) or take any of these medications
• Subjects with vegan diet
• Current smoker or used to smoke in the past 3 months
• Subject for surgery or had undergone surgery in the past 3 months History of bleeding tendencies or any condition predisposing to bleeding e.g. thrombocytopenia, abnormal liver function, liver disease (e.g. chronic hepatitis), gastrointestinal ulcers
• Subjects who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study
• Participation in another clinical trial within 30 days of enrolment into the study.
• History or current abuse of nicotine, drugs, or alcohol, or intake > 3 alcoholic beverages per day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supplemented; Each participant will be supplemented with ginger-based capsules.	Dietary supplement: ginger extract; Participants will receive a ginger-based capsule
Placebo Comparator: Placebo; Each participant will be supplemented with placebo capsules.	Other: Placebo; Participants will receive a placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)	Baseline and 24 weeks after supplementation
Fat mass	Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)	Baseline and 24 weeks after supplementation
Bone mineral content (BMC)	Bone mineral content in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)	Baseline and 24 weeks after supplementation
Gait speed test	Gait speed will be measured in meters per second (m/s). Participants will complete three walking trials, with each trial timed over a 6-meter distance to record gait speed in seconds.	Baseline and 24 weeks after supplementation
Handgrip strength	Evaluation of hand grip strength will be conducted using a dynamometer. Participants will be instructed to grip the dynamometer. The values will be recorded in kilograms (kg)	Baseline and 24 weeks after supplementation
Cognitive function	The assessment instrument, the Montreal Cognitive Assessment (MoCA) test will be administered. The evaluation involves assessing participants through questions and instructions covering executive and spatial cognitive domains. The maximum score is 30. A score of 26 and above indicates no cognitive impairment.	Baseline and 24 weeks after supplementation
Recall memory function	The Rey Auditory Verbal Learning Test (RAVLT) will be utilized. The RAVLT includes two distinct word lists (A and B). Participants will recall the items from list A over five trials (Memory A1 to A5). Following this, an interference list (list B), comprising 15 unrelated nouns, will be introduced, and participants will attempt to recall as many words as possible from it. Subsequently, participants will be asked to recall the words from list A (Delayed recall/Memory A6) without the examiner repeating the list. The number of correctly recalled words for each trial will be totaled to generate a score. Total Learning Score (Sum of Trials A1-A5) to indicate normal performance: 45-65, Mild Cognitive Impairment: 30-45, dementia: below 30. For delayed recall score (M6), to indicate normal performance: ≥8-12 words recalled, Mild Cognitive Impairment: 4-7 words recalled, and dementia: ≤3 words recalled.	Baseline and 24 weeks after supplementation
Working memory function	The Digit Span Test involves recalling numbers in the same order (forward), reverse order (backward), or ascending order (sequencing). The test starts with short sequences and increases in length to assess memory capacity. A higher score (20 - 30) indicates better cognitive function, while a lower score (0 - 19) may suggest attention or memory issues. The total score is 30.	Baseline and 24 weeks after supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure in mmHg using Sphygmomanometer	Baseline and 24 weeks after supplementation
C-Reactive protein (CRP)	CRP level in serum will be measured using Particle-Enhanced Turbidimetric Immunoassay (PETIA) in mg/dL	Baseline and 24 weeks after supplementation
Untargeted metabolomics for metabolite identification	Untargeted metabolomics for metabolite identification will be conducted using a Quadrupole-Orbitrap Mass Spectrometer. It begins with sample preparation, followed by liquid chromatography (LC) to separate metabolites before mass spectrometry analysis. Data is then processed using MetaboAnalyst to extract, align, and annotate metabolites by matching them to the Human Metabolome Database (HMDB) and Kyoto Encyclopedia of Genes and Genomes (KEGG) databases. The Principal Component Analysis (PCA) will be applied to identify significant metabolites, which are subsequently mapped to biological pathways for interpretation.	Baseline and 24 weeks after supplementation

Collaborators and Investigators

• Sponsor: National University of Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: UKM PPI/111/8-JEP-2022-395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Beginning 1 year after publication and ending 3 years after the publication of results
• IPD Sharing Access Criteria: The Principal Investigator will review the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No