Anti-Ageing Health Supplement From Ginger Extracts

NCT ID: NCT06828783

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Supplemented

Each participant will be supplemented with ginger-based capsules.

Group Type: EXPERIMENTAL

ginger extract

Intervention Type: DIETARY_SUPPLEMENT

Participants will receive a ginger-based capsule

Placebo

Each participant will be supplemented with placebo capsules.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive a placebo capsule

Interventions

ginger extract

Participants will receive a ginger-based capsule

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will receive a placebo capsule

Intervention Type: OTHER

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

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Canselor Tuanku Muhriz, UKM Medical Centre

Cheras, WP Kuala Lumpur, Malaysia

Countries

Malaysia

Other Identifiers

UKM PPI/111/8-JEP-2022-395

Identifier Type: -

Identifier Source: org_study_id