Anti-Ageing Health Supplement From Ginger Extracts

NCT06828783 | Completed

• 1 other identifier: UKM PPI/111/8-JEP-2022-395
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ageing Signs; Cognitive Decline; Musculoskeletal

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Blood pressure

  Baseline and 24 weeks after supplementation

• C-Reactive protein (CRP)

  Baseline and 24 weeks after supplementation

• Untargeted metabolomics for metabolite identification

  Baseline and 24 weeks after supplementation

Study Arms (2)

Supplemented

EXPERIMENTAL

Each participant will be supplemented with ginger-based capsules.

Dietary Supplement: ginger extract

Placebo

PLACEBO COMPARATOR

Each participant will be supplemented with placebo capsules.

Other: Placebo

Interventions

ginger extract DIETARY_SUPPLEMENT

Participants will receive a ginger-based capsule

Supplemented

Placebo OTHER

Participants will receive a placebo capsule

Placebo

Eligibility Criteria

• Age: 48 Years - 63 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz, UKM Medical Centre

Cheras, WP Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 14, 2025
• Study Start: November 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 year after publication and ending 3 years after the publication of results
• Access Criteria: The Principal Investigator will review the request.

Locations

MY (1)