Ageing SignsNCT06828783
Anti-Ageing Health Supplement From Ginger Extracts
A study testing ginger extract in people with Ageing Signs and Cognitive Decline, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 63 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ageing Signs, Cognitive Decline, Musculoskeletal
- What is being tested?
- ginger extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 7 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 63 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Canselor Tuanku Muhriz, UKM Medical Centre
Cheras, WP Kuala Lumpur, 56000
About this study
Official title: 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.
- Conditions
- Ageing Signs, Cognitive Decline, Musculoskeletal
- Being tested
- ginger extract, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginger extractDietary supplement
Participants will receive a ginger-based capsule
PlaceboOther
Participants will receive a placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Supplemented | Experimental | Each participant will be supplemented with ginger-based capsules. Receives: Dietary Supplement: ginger extract |
| Placebo | Placebo comparator | Each participant will be supplemented with placebo capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Measured: Baseline and 24 weeks after supplementation
Fat mass
Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 24 weeks after supplementation
Secondary outcomes (3)
Blood pressure
Blood pressure in mmHg using Sphygmomanometer
Measured: 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
Measured: 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.
Measured: Baseline and 24 weeks after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start7 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ageing SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828783
- Sponsor's protocol ID
- UKM PPI/111/8-JEP-2022-395
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Anti-Ageing Health Supplement From Subcritical Water Extraction of Zingiber Officinale Roscoe (Ginger) Bioactive Compounds
- ClinicalTrials.gov ID
- NCT06828783
- Acronym / sponsor ID
- UKM PPI/111/8-JEP-2022-395
- Conditions
- Ageing Signs, Cognitive Decline, Musculoskeletal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemented | Experimental | Dietary Supplement: ginger extractEach participant will be supplemented with ginger-based capsules. |
| Placebo | Placebo comparator | Other: PlaceboEach participant will be supplemented with placebo capsules. |
Who may qualify
- Ages
- 48 to 63 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ginger extractParticipants will receive a ginger-based capsule | Dietary supplement | Supplemented |
| PlaceboParticipants will receive a placebo capsule | Other | Placebo |
Primary outcome
Muscle mass
Time frame: Baseline and 24 weeks after supplementation
Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Fat mass
Time frame: Baseline and 24 weeks after supplementation
Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Bone mineral content (BMC)
Time frame: Baseline and 24 weeks after supplementation
Bone mineral content in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Gait speed test
Time frame: Baseline and 24 weeks after supplementation
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.
Handgrip strength
Time frame: Baseline and 24 weeks after supplementation
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)
Cognitive function
Time frame: Baseline and 24 weeks after supplementation
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.
Recall memory function
Time frame: Baseline and 24 weeks after supplementation
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.
Working memory function
Time frame: Baseline and 24 weeks after supplementation
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.
3 secondary outcomes
Blood pressure
Time frame: Baseline and 24 weeks after supplementation
C-Reactive protein (CRP)
Time frame: Baseline and 24 weeks after supplementation
Untargeted metabolomics for metabolite identification
Time frame: Baseline and 24 weeks after supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ginger extract in people with Ageing Signs and Cognitive Decline, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: Baseline and 24 weeks after supplementation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.