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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
90
Participants will receive a ginger-based capsule
Participants will receive a placebo capsule
Hospital Canselor Tuanku Muhriz, UKM Medical Centre
Cheras, WP Kuala Lumpur, Malaysia
Muscle mass
Appendicular lean mass in kilograms, kg will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Time frame: Baseline and 24 weeks after supplementation
Fat mass
Fat mass in gram, g will be measured using Dual-Energy X-ray Absorptiometry, (DEXA)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 24 weeks after supplementation
Blood pressure
Blood pressure in mmHg using Sphygmomanometer
Time frame: 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
Time frame: 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.
Time frame: Baseline and 24 weeks after supplementation
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