Effects of Reducose®, a mulberry leaf extract formulation, on post-meal glycaemic control, insulin response, satiety, and appetite regulation in healthy adults (SATISPHY)

ISRCTN	ISRCTN75298105
DOI	https://doi.org/10.1186/ISRCTN75298105
Sponsor	Phynova Group Limited
Funder	Phynova Group Limited

Submission date: 16/03/2026
Registration date: 18/03/2026
Last edited: 28/04/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study will examine the effects of two dietary supplements containing mulberry leaf extract compared with placebo on their ability to reduce the rise in blood sugar and plasma insulin and increase the levels of hormones that regulate appetite after eating a complete meal. The study will further investigate whether the supplements change feelings of satiety (fullness and hunger) throughout the day.

Who can participate?
Healthy men and women aged 18 years or older without diabetes and with normal fasting blood glucose.

What does the study involve?
Participants will attend three morning visits after fasting overnight. At each visit, they will take either Reducose® mulberry leaf extract, an exploratory botanical formulation containing Reducose®, or a matched placebo capsule containing inert ingredients before consuming a standardised breakfast meal. Blood samples will be taken over 3 hours taken at 0, 15, 30, 45, 60, 90, 120 and 180. Throughout the visit, participants will complete short questionnaires about hunger, fullness, meal palatability and food noise, and they will also complete a 24-hour dietary recall before and after each visit. Each visit lasts around four hours and is separated by at least two days.

What are the possible benefits and risks of participating?
Participants may gain general insight into their own body composition and some of their blood measurements collected during the study. However, these results are for research purposes only and will not be interpreted as medical information, diagnosis, or health advice. The study itself may help researchers understand how natural supplements influence appetite and post-meal glucose responses, which could support the development of non-invasive approaches to appetite and glucose regulation in the future.
Risks are minimal but may include:
1. Mild discomfort or bruising from blood sampling
2. Temporary soreness at the cannula site
The study team is trained in first aid and phlebotomy, and all procedures follow University safety guidelines. If any unexpected findings occur (e.g., unusual glucose levels), participants will be advised to contact their GP.

Where is the study run from?
University of Westminster (UK)

When is the study starting and how long is it expected to run for?
March 2026 to December 2026

Who is funding the study?
Phynova Group Limited (UK)

Who is the main contact?
1. Prof. Mohammed Gulrez Zariwala, M.Zariwala@westminster.ac.uk
2. Dr Helena Tiekou Lorinczova, h.teikoulorinczova@westminister.ac.uk
3. Dr Preeti Jethwa, Pjethwa@phynova.com

Contact information

Dr Helena Teikou Lorinczova
Scientific

Centre for Nutraceuticals
School of Life Sciences
115 New Cavendish Street
London
W1W 6UW
United Kingdom

ORCID ID	0000-0002-9754-0737
Phone	+44 (20)7911 5000
Email	h.teikoulorinczova@westminister.ac.uk

Dr Preeti Jethwa
Public, Scientific

2 Brookhill Way, Banbury
Banbury
OX16 3ED
United Kingdom

ORCID ID	0000-0003-4401-284X
Phone	+44 (0)1993 880 700
Email	info@phynova.com

Prof Mohammed Gulrez Zariwala
Principal investigator

Centre for Nutraceuticals
University of Westminster
School of Life Sciences
115 New Cavendish Street
London
W1W 6UW
United Kingdom

ORCID ID	0000-0001-9944-8451
Phone	+44 (20) 7911 5000
Email	M.Zariwala@westminster.ac.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Crossover
Purpose	Dietary supplement
Scientific title	A double-blind, placebo-controlled, randomised, single-centre, three-arm crossover study to evaluate the effects of Reducose® mulberry leaf extract and a mulberry extract based botanical formula versus placebo on postprandial glucose, insulin, GLP1, PYY and appetite responses in healthy adults (SATISPHY)
Study acronym	SATISPHY
Study objectives	1. To determine whether 250 mg Reducose® mulberry leaf extract decreases incremental area under the curve (iAUC) for blood glucose following a mixed macronutrient meal compared with placebo. 2. To determine whether a proprietary dietary supplement formulation decreases incremental area under the curve (iAUC) for blood glucose following a mixed macronutrient meal compared with placebo. 3. To evaluate the effects of each active independently versus placebo on plasma insulin, GLP-1 and PYY. 4. To assess peak concentration (Cmax) for glucose, insulin, GLP-1 and PYY for each intervention independently versus placebo 5. To evaluate appetite perception using validated visual analogue scale (VAS) questionnaires for each intervention independently vs placebo 6. To evaluate 24-hour appetite, hunger and food noise for each intervention independently versus placebo. 7. The study is powered for placebo-controlled comparisons only and no formal statistical comparison between the two active interventions is prespecified.
Ethics approval(s)	Approved 23/12/2025, College Research and Knowledge Exchange Ethics Committees (CRECs) (Liberal Arts and Sciences (LAS), University of Westminster, 309 Regent Street, London, W1B 2HW, United Kingdom; +44 (0)20 7911 5000; A.Voiculescu@westminster.ac.uk), ref: ETH2526-0070
Health condition(s) or problem(s) studied	Post‑prandial glycaemic control and appetite regulation in healthy adults
Intervention	This is a double blind, randomised, placebo controlled, three arm crossover study conducted at the Centre for Nutraceuticals, University of Westminster. Each participant completes three intervention visits, receiving all treatments in a randomised sequence with a minimum 48‑hour washout between visits. Participants will be randomised using a Williams design with six balanced sequences (ABC, ACB, BAC, BCA, CAB, CBA) to ensure equal distribution of treatment order and control for first‑order carryover effects. The three interventions are: Arm 1: Reducose® – 250 mg mulberry leaf extract (equivalent to 12.5 mg DNJ) Arm 2: Exploratory Proprietary botanical formulation – containing 250 mg mulberry leaf extract plus additional citrus bioactives Arm3: Placebo – microcrystalline cellulose, matched in appearance to active capsules At each visit, participants consume two capsule (active or placebo) immediately before eating a standardised mixed macronutrient test meal. The meal must be consumed within 10 minutes. A venous cannula is inserted on arrival, and blood samples are collected over a 3-hour period to measure glucose, insulin, GLP‑1 and PYY. Participants also complete validated Visual Analogue Scale (VAS) questionnaires assessing hunger, fullness, satisfaction, and palatability at repeated time points. A 24 hour dietary recall and Food Noise Questionnaire (FNQ) are completed before and after each visit to assess extended appetite effects. The crossover design allows each participant to act as their own control. Treatments are compared independently against placebo; no head to head comparison between the two active interventions is prespecified.
Intervention type	Supplement
Primary outcome measure(s)	Incremental area under the curve (iAUC) for postprandial blood glucose measured using venous whole glucose concentrations collected via an indwelling cannula. iAUC will be calculated using the trapezoidal method, subtracting baseline values to quantify the incremental glucose response. Measured at 0 to 120 minutes following consumption of the standardised test meal, with repeated sampling across the 2‑hour postprandial period.
Key secondary outcome measure(s)	Incremental area under the curve (iAUC) for postprandial glucose measured using venous whole blood glucose concentrations with iAUC calculated via the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal Incremental area under the curve (iAUC) for plasma insulin measured using plasma insulin concentrations analysed via appropriate assay with iAUC calculated using the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal Incremental area under the curve (iAUC) for GLP‑1 measured using plasma GLP-1 concentrations analysed via appropriate assay with iAUC calculated using the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal Incremental area under the curve (iAUC) for PYY measured using plasma PYY concentrations analysed via appropriate assay with iAUC calculated using the trapezoidal method after baseline subtraction at 0–180 minutes following consumption of the standardised test meal Peak postprandial concentration (Cmax) for glucose, insulin, GLP‑1 and PYY measured using the highest venous plasma concentration observed during the sampling period at any timepoint within 0–180 minutes post‑meal Time to peak concentration (Tmax) for glucose, insulin, GLP‑1 and PYY measured using the timepoint at which the maximum venous plasma concentration occurs, at any time within the 0–180 minute sampling window Subjective appetite and satiety ratings measured using validated Visual Analogue Scale (VAS) questionnaires assessing hunger, fullness, satisfaction and prospective food intake, at at baseline and repeated intervals across the 0–180 minute postprandial period Intrusive food‑related thoughts measured using the Food Noise Questionnaire (FNQ) at 24 hours before each intervention visit and 24 hours after each visit Energy intake and dietary composition over 24 hours measured using a structured 24‑hour dietary recall completed before and after each intervention visit at the 24‑hour pre‑visit and 24‑hour post‑visit timepoints
Completion date	31/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Male and female participants aged 18 years and over 2. BMI between 18.5 and 30 kg/m² (lean and overweight individuals) 3. Generally healthy, with no clinically significant medical conditions as determined by screening 4. Stable use of permitted medications, including: 4.1. Oral contraceptives 4.2. Acetylsalicylic acid (aspirin) 4.3. Thyroxine 4.4. Vitamin and mineral supplements 4.5. Medications for hypertension or osteoporosis 5. Willing and able to comply with all study procedures 6. Able to provide written informed consent
Key exclusion criteria	1. Fasting blood glucose >6.9 mmol/L 2. Body mass index (BMI) >30 kg/m² 3. Known food allergies or intolerances, including lactose intolerance 4. Use of anti-hyperglycaemic medications or insulin 5. Major medical or surgical event requiring hospitalisation within the past 3 months 6. Presence of diseases or use of medications that affect digestion or nutrient absorption 7. Use of steroids, protease inhibitors, or antipsychotics (due to their effects on glucose metabolism and body fat distribution) 8. Use of medications known to affect glucose tolerance (excluding oral contraceptives) 9. Current participation in dieting or intentional weight‑loss programmes 10. Consumption of >14 units of alcohol per week 11. Use of implanted medical devices such as pacemakers 12. Current smokers or users of nicotine products 13. Clinically significant depression or other mental health conditions that may interfere with study participation 14. Inability or unwillingness to provide informed consent
Date of first enrolment	16/03/2026
Date of final enrolment	30/06/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Centre of Nutraceuticals

University of Westminster
309 Regent Street
London
W1B 2HW
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan

Editorial Notes

28/04/2026: Contact details updated.
16/03/2026: Study's existence confirmed by the University of Westminster.