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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemented | Experimental | Each participant will be supplemented with ginger-based capsules. |
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| Placebo | Placebo Comparator | Each participant will be supplemented with placebo capsules. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ginger extract | Dietary Supplement | Participants will receive a ginger-based capsule |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male participants are often preferred in clinical trials due to their more stable physiology, reducing variability in results. Hormonal fluctuations in females from menstrual cycles, pregnancy, and menopause can affect metabolism, drug absorption, and inflammatory responses, complicating data analysis. Men also have higher muscle mass and lower fat percentage, influencing the effects of drugs or supplements on muscle strength and metabolism. Additionally, avoiding potential hormonal interactions and reproductive health risks makes early-phase trials safer and more controlled. While modern trials aim for gender balance, male participants help minimize biological variability and ensure clearer outcomes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Canselor Tuanku Muhriz, UKM Medical Centre | Cheras | WP Kuala Lumpur | 56000 | Malaysia |
All IPD that underlie results in a publication
Beginning 1 year after publication and ending 3 years after the publication of results
The Principal Investigator will review the request.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000713927 | ginger extract |
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| Placebo |
| Other |
Participants will receive a placebo capsule |
|
| 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 |
| 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 |