Efficacy of an organic pomegranate polyphenol complex (VIQUA®) in type 1 primary osteoporosis in post-menopausal women
| ISRCTN | ISRCTN13473651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13473651 |
| Secondary identifying numbers | IL-213678 |
- Submission date
- 22/06/2023
- Registration date
- 07/07/2023
- Last edited
- 04/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoporosis is characterized by the decline of bone mass and microarchitecture, leading to increased fragility fractures. Though there are many types and causes, Oxidative stress and inflammatory reactions are major factors that induce osteoporosis by promoting bone resorption and inhibiting bone formation. Current treatment options for osteoporosis have limitations and side effects and there is a requirement for effective, safe, and natural supplements to reduce and prevent this condition. This study aims to evaluate a supplement called VIQUA®, a natural polyphenol complex with a high concentration of unique metabolites derived from organic pomegranate, sourced from a microbiome-rich biodynamic plantation, in postmenopausal women with osteoporosis.
Who can participate?
Healthy postmenopausal women aged between 45 and 70 years old
What does the study involve?
Participants will be randomly assigned to a once-daily supplement or a placebo/dummy supplement for 36 weeks. The study objectives included assessing changes in bone mineral density, bone turnover markers, and antioxidant and inflammatory markers over the 36-week period.
What are the possible benefits and risks of participating?
The results of this study will provide valuable insights into the potential benefits of VIQUA® in improving bone health in postmenopausal women. There is no known risk, no side effect was detected using the trial product.
Where is the study run from?
INNOVATION LABO Sciences Co., Ltd (Japan)
When is the study starting and how long is it expected to run for?
July 2021 to July 2023
Who is funding the study?
INNOVATION LABO Sciences Co., Ltd (Japan)
Who is the main contact?
Dr Yuki Ikeda, development@innovationlabo.com (Japan)
Contact information
Scientific
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041
Japan
 ORCID ID |
0000-0001-6067-4574 |
|---|---|
| Phone | +81 (0)3 3552 5335 |
| development@innovationlabo.com |
Study information
| Study design | Double-blind interventional randomized placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital, Medical and other records |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Double-blind, placebo-controlled clinical study to analyze the efficacy of an organic pomegranate polyphenol complex supplementation on bone mineral density, bone turnover markers, inflammatory status, and antioxidant status in post-menopausal women |
| Study acronym | VIQOSTEO |
| Study objectives | VIQUA® increases bone mineral density, bone turnover markers, inflammatory status, and antioxidant status |
| Ethics approval(s) |
Approved 08/02/2022, Japanese Society of Anti-Aging Nutrition (Ginza, Chuo-ku, Tokyo 6-6-1, 104-0061, Japan; +81 3 3552 5277; coordinator@jaan.jp), ref: ILOS210617-N713 |
| Health condition(s) or problem(s) studied | Prevention of osteoporosis in postmenopausal women |
| Intervention | Subjects were randomly assigned in a 1:1 ratio to receive either the trial product VIQUA® (250mg in capsules) or Placebo (Dextrin 250mg in capsules) once daily (daily dosage of 300mg) for 36 weeks. Patients were asked to take Viqua or the placebo orally in the morning before breakfast. Block randomization is used to divide potential patients into m blocks of size 2n, randomize each block such that n patients are allocated to A and n to B then choose the blocks randomly. This method ensures equal treatment allocation within each block if the complete block is used. The primary outcome measure is the change in bone mineral density (BMD) from baseline to 36 weeks. BMD of the lumbar spine and proximal femur were assessed by dual-energy x-ray absorptiometry at baseline, 12 weeks, 24 weeks, and 36 weeks. The secondary outcome measures include bone turnover markers, inflammatory status, and antioxidant status of the body. Bone turnover markers tested are osteocalcin, bone-specific alkaline phosphatase (BAP), receptor activator of nuclear factor kappa-B ligand (RANKL), and C-terminal telopeptide. For the analysis of these blood markers, blood samples were collected after 12h overnight fasting and samples were immediately centrifuged and stored for biochemical analysis. All blood markers were tested at baseline, and 12, 24, and 36 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | Change in bone mineral density (BMD) from baseline to 36 weeks. BMD of the lumbar spine and proximal femur are assessed by dual-energy x-ray absorptiometry at baseline, 12 weeks, 24 weeks, and 36 weeks |
| Secondary outcome measures | The following secondary outcome measures are assessed at baseline, and 12, 24, and 36 weeks: 1. Serum levels of bone turnover markers, osteocalcin, bone-specific alkaline phosphatase (BAP), receptor activator of nuclear factor kappa-B ligand (RANKL), and C-terminal telopeptide measured using biochemical analysis of blood 2. Inflammatory status measured using hs-CRP analysis in blood 3. Antioxidant status measured using Total Antioxidant Status analysis in blood |
| Overall study start date | 19/07/2021 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 45 Years |
| Upper age limit | 70 Years |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Post-menopausal female subjects 2. Aged between 45 and 70 years old 3. Subjects with at least 12 months of amenorrhea 4. T-score of −2.5 or less in bone mineral density analysis |
| Key exclusion criteria | 1. History of cancer or thyroid dysfunction 2. Hormone replacement therapy (HRT) within the last 6 months 3. Known allergy to any of the ingredients in the test product 4. Consumed any nutritional supplements within 1 month from the start of the study 5. Any serious mental or physical illnesses that might interfere with the outcome of the study |
| Date of first enrolment | 02/09/2022 |
| Date of final enrolment | 14/10/2022 |
Locations
Countries of recruitment
- Japan
Study participating centre
Yokohama-shi
Kanagawa-ken
Yokohama
220-0003
Japan
Sponsor information
Industry
Shintomi HJ bldg 5F
1-12-7 Shintomi
Tokyo
104-0041 Chuo-ku
Japan
| Phone | +81 (0)3 3552 5335 |
|---|---|
| tokyo@innovationlabo.com | |
| Website | https://www.innovationlabo.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Yuki Ikeda, development@innovationlabo.com. Anonymised IPD will be available upon publication of results and for a period of 2 years. Consent from participants was required and obtained. |
Editorial Notes
04/07/2023: Trial's existence confirmed by the Ethics Review Committee of the Japanese Society of Anti-Aging Nutrition (Japan).
