Clinical trial to evaluate Reducose® mulberry leaf extract as a functional food ingredient to improve metabolic health
| ISRCTN | ISRCTN89882877 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89882877 |
| Secondary identifying numbers | PYN-CT-008 |
- Submission date
- 09/10/2024
- Registration date
- 16/10/2024
- Last edited
- 17/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
This study is investigating whether a mulberry leaf extract called Reducose® can help improve health indicators like blood sugar levels, body weight, and gut health. The goal is to see if Reducose® can reduce blood sugar spikes after eating by slowing down the absorption of sugars in the gut. The study will test the supplement over 12 weeks in healthy, overweight individuals.
Who can participate?
Healthy, overweight individuals with a body mass index (BMI) between 25 and 29.9 kg/m² and body fat percentages of at least 20% for males and 30% for females can participate.
What does the study involve?
Participants will be randomly assigned to take either Reducose® or a placebo. They will visit the Oxford Brookes Centre for Nutrition and Health three times for various tests, including blood tests and body measurements. Participants will also wear a small device to monitor blood sugar levels and collect stool samples at home to check gut health. They will complete questionnaires about their feelings of fullness after meals.
What are the possible benefits and risks of participating?
Participants might experience mild side effects like stomach discomfort if they are sensitive to mulberry leaf extract. The risks of the study are minimal and similar to routine medical tests. Benefits include receiving Amazon vouchers for participation and getting detailed information about their body composition and blood pressure.
Where is the study run from?
The study is conducted at the Oxford Brookes Centre for Nutrition and Health in Headington, Oxford, UK.
When is the study starting and how long is it expected to run for?
September 2023 to March 2026
Who is funding the study?
The study is funded by Innovate UK and Phynova Group Limited, the company that makes Reducose®. Innovate UK is also funding the Oxford Brookes Centre for Nutrition and Health.
Who is the main contact?
Dr Sangeetha Thondre, pthondre@brookes.ac.uk
Dr Jonathan Tammam
Andrew Gallagher, agallagher@phynova.com
Contact information
Public, Scientific
Office 3 at Magenta
2 Brookhill Way
Banbury
OX16 3ED
United Kingdom
 ORCID ID |
0000-0002-5974-4093 |
|---|---|
| Phone | +44 (0) 1993 880700 |
| agallagher@phynova.com |
Principal Investigator
Oxford Brookes Centre for Nutrition and Health
Faculty of Health and Life Sciences
Oxford Brookes University Headington Campus
Oxford
OX3 0BP
United Kingdom
| ORCID ID |
0000-0003-2065-8443 |
|---|---|
| Phone | +44 (0) 1865 483988 |
| pthondre@brookes.ac.uk |
Study information
| Study design | Single-centre randomized placebo-controlled parallel group design trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home, University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | A twelve-week randomised, placebo-controlled study on the effect of Reducose® on glucose, insulin, haemoglobin A1c, satiety, body composition, lipid profile, inflammatory markers and changes in gut microbiome in an overweight population. REMET (Reducose Metabolic Trial) |
| Study acronym | REMET |
| Study hypothesis | The aim of this placebo-controlled study is to examine the effect of mulberry leaf-derived food ingredient (Reducose®) on glucose levels, insulin, HbA1c, weight, body composition, satiety, lipid profile, blood pressure, inflammatory markers, and beneficial changes in gut microbiome and microbiome metabolites in overweight individuals. |
| Ethics approval(s) |
Approved 08/02/2024, Oxford Brookes University Health & Social Care Research Ethics Sub-Committee (Gipsy Lane and Headington Hill Sites, Oxford Brookes University, Headington, Oxford, OX3 0BP, United Kingdom; +44 (0) 1865 483297; ethics@brookes.ac.uk), ref: 231762 |
| Condition | Overweight |
| Intervention | Prior to the start of the intervention, participants will be randomly assigned to one of the two parallel groups using block randomisation with randomly permuted blocks (2, 4, 6, or 8 block size). 1. Three grams of food-grade beadlets containing 250mg Reducose mulberry leaf extract (standardised to contain 12.5mg 1-deoxynojirimycin) taken immediately before dinner and the next largest meal of the day. 2. Matched 3g placebo beadlets (cellulose). Participants to take interventions twice daily for 12-weeks. |
| Intervention type | Supplement |
| Primary outcome measure | Blood glucose concentrations measured via venipuncture and CGM. Venipuncture measurements are collected at clinic visits at week 1, week 6, and week 12, and by CGMs used during weeks 1-2, and weeks 11-12. |
| Secondary outcome measures | 1. Body weight measured using a body composition analyser at week 1, week 6, and week 12. 2. Body composition measured through bioimpedance using a body composition analyser at week 1, week 6, and week 12. 3. Height measured using a stadiometer at week 1, week 6, and week 12. 4. Waist and hip circumference measured using a standard non-stretch tape at week 1, week 6, and week 12. 5. Systolic and diastolic blood pressure measured using a digital blood pressure monitor at week 1, week 6, and week 12. 6. Intraday glucose variability measured for 14 days from week 1 and week 10 using continuous glucose monitors. 7. 14-day food records collected from week 1 and week 10 using the Nutritics Libro App. 8. Satiety outcomes (hunger, fullness, desire to eat, and prospective food consumption) measured over 8 hours during week 1, week 6, and week 12 using an online visual analogue scale (VAS). 9. Microbiome functional data (measurement of acetate, propionate, SCFA ratio, iso-butyrate, iso-valerate) and compositional data (total bacteria, firmicutes, bacteriodetes, lactobacillus, bifidobacterium) measured using NeoVos Advanced Gut Test at week 1 and week 12. 10. Clinical biochemistry outcomes insulin, HbA1c, blood lipids, adiponectin, leptin, inflammatory markers (CRP, TNF-a, IL-6) measured via venipuncture. Measurements are collected at clinic visits at week 1, week 6, and week 12. |
| Overall study start date | 03/09/2023 |
| Overall study end date | 31/03/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | 1. Body mass index (BMI) ≥25 kg/m² or ≤29.9 kg/m² 2. Body fat percentages ≥20% for males, ≥30% for females |
| Participant exclusion criteria | 1. Aged <18 or >60 years 2. Body mass index (BMI) <25 kg/m² or >29.9 kg/m² 3. Body fat percentages < 20% for males, <30% for females 4. HbA1c >6.5% 5. Any known food allergy or intolerance to the placebo or test product 6. Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients 7. Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions 8. Major medical or surgical event requiring hospitalization within the preceding 3 months 9. Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution) 10. Volunteers self-reporting as currently dieting (including ketogenic) or having lost >5% body weight in the previous year 11. Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change during the study 12. Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit 13. Participants with restricted or abnormal eating behaviour 14. Regular intake of a food supplement with effects on glucose metabolism and satiety (e.g. prebiotics, proteins, chromium, cinnamon, berberine, biotin) 15. Smoker in the last 3 months 16. Heavy alcohol consumers, more than 14 units per week (14 units is equivalent to 6 pints of average-strength beer or 10 small glasses of low-strength wine) |
| Recruitment start date | 28/10/2024 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Brookes University Gipsy Lane Campus Headington
Oxford
OX3 0BP
United Kingdom
Sponsor information
Industry
Office 3 at Magenta
2 Brookhill Way
Banbury
OX16 3ED
England
Australia
| Phone | +44 (0) 1993 880700 |
|---|---|
| info@phynova.com | |
| Website | https://www.phynova.com |
University/education
Oxford Brookes Centre for Nutrition and Health
School of Sport, Nutrition and Allied Health Professions
Gipsy Lane Campus Headington
Oxford
OX3 0BP
England
United Kingdom
| Phone | +44 (0) 1865 483988 |
|---|---|
| oxbcnh@brookes.ac.uk | |
| Website | https://www.brookes.ac.uk/research/units/hls/centres/oxbcnh/ |
"ROR" |
https://ror.org/04v2twj65 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- innovateuk
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results obtained in this study will be used to write a report to the funding body (Innovate UK) and the lead study partner, Phynova. It is intended that the results of the trial will be published in a medical/scientific journal. The results may be presented at a scientific conference. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Andrew Gallagher, agallagher@phynova.com after publication of the results. |
Editorial Notes
17/10/2024: Internal review.
09/10/2024: Trial's existence confirmed by Oxford Brookes University.
