Menopause Nutritional, Metabolic, Endocrine Menopause
Conditions
Interventions
Participants are randomised based on the randomization blocks of four and will be assigned to either receive Tualang honey or Honey Cocktail base on a randomization table which was computer generated.
Sponsors
University of Science, Malaysia (Universiti Sains Malaysia)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 45 -65 years old 2. Surgically or naturally menopausal for more than five years 3. Healthy (as determined by laboratory results, medical history and physical exam) with only stable medical problems 4. Provision of written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Abnormal pelvic ultrasound examination 2. Major uncontrolled psychiatric disorders 3. History of alcohol or drug abuse 4. Any renal or hepatic disorders 5. Active peptic ulcer or bleeding disorder 6. Unstable cardiac history, defined as: myocardial infarction (MI); coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD) within the past 12 months 7. Allergy or sensitivity to study supplement ingredients 8. Not on HRT within 3 month prior to randomization 9. Use of oral natural herbal health products/dietary supplements within 3 month prior to randomization 10. Taking medication for the treatment of bone, including: Rocatriol, Fosamax and Protaxos within 3 months prior to randomization 11. Clinically significant abnormal laboratory results at screening 12. Participation in a clinical research trial within 30 days prior to randomization 13. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood pressure is measured by an automatic blood pressure monitor at baseline and 12 months 2. Fasting lipid profile is measured by analysing blood samples using an automated lipid analyser at baseline and 12 months 3. Follicle stimulating hormone, luteinizing hormone, testosterone levels and estradiol levels are measured by analysing blood samples using an automated hormone analyser at baseline and 12 months 4. Bone density is measured using a mini bone ultrasound device at baseline and 12 months 5. Oxidative stress is measured by analysing blood samples at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychosexual changes are measured using the Validated Malay version of Women's Health Questionnaire and the Validated Malay version of Female Sexual Function Index at baseline and 12 months 2. Adverse events are measured through interviews and examinations by the clinician in charge of the trial and the completiong of an Adverse Events Form at 6 months and 12 months 3. Serious adverse event rate is measured by calculating the incidence of death, in-patient hospitalization, malignancy, and/or result of an overdose within 6 months and 12 months 4. Pelvic pathology is assessed using pelvic ultrasound at baseline and 12 months 5. Liver and renal function is measured using kidney and liver function tests on blood samples at baseline and 12 months | — |
Countries
Malaysia
Outcome results
None listed