A clinical trial to investigate the effect of a proprietary mulberry leaf extract (Reducose®) on lowering blood glucose rises after consuming a drink containing sugar (sucrose)

INTERVENTION: The trial has a randomised crossover design and so each subject would act as their own control. Randomisation sequence was generated using www.randomization.com using the randomly permuted blocks method to assign which treatment subjects would receive first. Researchers recruiting the participants were unaware of the allocation sequence (concealed allocation). Participants were assigned to a participant number according to their chronological order of enrolment in the study. The allocated participant number was used to identify the participants and their corresponding intervention sequence. Participants will be recruited to attend two study visits, with at least 48 h apart for washout. The study will evaluate a single dose of 250 mg mulberry leaf extract (Reducose) against matched placebo. The mulberry leaf extract is standardised to contain 5% (m/m) 1‐deoxynojirimycin (DNJ). Each 250 mg dose contains 12.5 mg DNJ. Test product contained 250 mg Reducose mulberry leaf extract directly blended into 75 g sucrose. Placebo product contained 75 g sucrose alone. Reducose has minimal impact on taste, smell, and colour of the sucrose blend. The test meal or placebo meal are packaged in opaque containers and dissolved in 250 ml water and are consumed. The participants and study team are blind to allocation. At each study visit, plasma insulin and glucose concentrations will be measured by fingerprick blood sample at 0, 15, 30, 45, 60, 90, and 120 min. CONDITION: Postprandial glycaemic control ; Nutritional, Metabolic, Endocrine ; Postprandial glycaemic control PRIMARY OUTCOME: Incremental area under curve for plasma glucose concentration over 120 min, plasma glucose concentration collected by fingerprick blood sample at 0, 15, 30, 45, 60, 90, and 120 min SECONDARY OUTCOME: Incremental area under curve for plasma insulin concentration over 120 min, plasma insulin concentration collected by fingerprick blood sample at 0, 15, 30, 45, 60, 90, and 120 min INCLUSION CRITERIA: 1. Consent to study protocol 2. Aged 18‐60 years 3. BMI 20‐29.9 kg/m² 4. Fasting blood glucose <6.1 mmol/l