Clinical trial NCT06828783: Anti-Ageing Health Supplement From Ginger Extracts
Official title: Development of Anti-Ageing Health Supplement From Subcritical Water Extraction of Zingiber Officinale Roscoe (Ginger) Bioactive Compounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing Signs
Cognitive Decline
Musculoskeletal
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 90
Sex: MALE
Minimum age (years): 48
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle mass
timeFrame: Baseline and 24 weeks after supplementation
measure: Fat mass
timeFrame: Baseline and 24 weeks after supplementation
measure: Bone mineral content (BMC)
timeFrame: Baseline and 24 weeks after supplementation
measure: Gait speed test
timeFrame: Baseline and 24 weeks after supplementation
measure: Handgrip strength
timeFrame: Baseline and 24 weeks after supplementation
measure: Cognitive function
timeFrame: Baseline and 24 weeks after supplementation
measure: Recall memory function
timeFrame: Baseline and 24 weeks after supplementation
measure: Working memory function
timeFrame: Baseline and 24 weeks after supplementation
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline and 24 weeks after supplementation
measure: C-Reactive protein (CRP)
timeFrame: Baseline and 24 weeks after supplementation
measure: Untargeted metabolomics for metabolite identification
timeFrame: Baseline and 24 weeks after supplementation
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz, UKM Medical Centre
state: WP Kuala Lumpur
Study officials:
References: