This study aims to demonstrate the effect of visualizing the effect of consuming a functional milk on postprandial glucose response on perceived benefits compared to absence of visualization.
This is a multi-centric double-blind, randomized, 2-arm parallel group clinical study to investigate the effect of of consuming a functional milk on postprandial glucose response on perceived benefits compared to absence of visualization. The study is divided in 3 periods: 1) reference period in which both groups will have a blinded Continuous Glucose Monitoring (CGM) sensor; 2) intervention period where participants will have either CGM feedback visualization or blinded CGM feedback visualization, while both arms consume a functional milk powder; 3) follow-up in free-living conditions. Outcomes of this study will include plasma HbA1c, glucose, insulin and lipids levels, perceived benefits and adherence questionnaire, dietary intake and physical activity and real usage. This will be conducted in a total of 170 healthy adults of Chinese ethnicity aged 45-75 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
170
The subject will have CGM feedback visualization
milk supplemented with mulberry leaves extract
The subject will have blinded CGM feedback visualization
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
Likert-scale for perceived benefit
A Likert-scale from 1 (very unlikely) to 7 (very likely) on perceived product benefits
Time frame: From enrollment to day 30
Likert-scale for product experience
A Likert-scale from 1 (very unlikely) to 7 (very likely) on product experience.
Time frame: From enrollment to day 15 and day 30
Likert-scale for perceived benefit
A Likert-scale from 1 (very unlikely) to 7 (very likely) on perceived product benefits.
Time frame: From enrollment to day 15
Actual usage and recommendation behavior
Actual usage and recommendation behavior will be measured comparing answers at the end of the follow up period (V6) from Group A vs. Group B to 5 questions generated for this study. 1. Have you bought Yiyang TangLv since the intervention ended (visit 5)? Yes No 1.1 If so, how many tins or/and sachet did you buy? (Specify number) This includes for yourself or family \_\_\_ tins * sachets 2. How often have you drank Yiyang TangLv since the end intervention (visit 5)? Never \<3 times a week 4-6 days a week 7 days a week 3. Did you drank it in the morning with breakfast? Yes No 4. Has anyone else in your household drank Yiyang TangLv since the intervention ended (visit 5)? Yes No not sure 5. Have you recommended Yiyang TangLv to anyone since the study end of the intervention (visit 5)? Yes No
Time frame: At day 88
CGM markers - iAUC0-60,120,180 min post-breakfast
Changes in CGM markers in response to IP intake (mmol/L x min) .
Time frame: From enrollment to day 30
CGM markers - 24h iAUC
Changes in CGM markers. (mmol/L x min)
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Time frame: From enrollment to day 30
CGM markers - iCmax
Changes in CGM markers in response to IP intake (mmol/L) .
Time frame: From enrollment to day 30
CGM markers - Tmax
Changes in CGM markers in response to IP intake (min).
Time frame: From enrollment to day 30
CGM markers - time in range (TIR)
Changes in CGM markers (%).
Time frame: From enrollment to day 30
CGM markers - average interstitial glucose
Changes in CGM markers (mmol/L).
Time frame: From enrollment to day 30
CGM markers - coefficient of variance (CV)
Changes in CGM markers (%) .
Time frame: From enrollment to day 30
CGM markers - mean amplitude of glycaemic excursion (MAGE)
Changes in CGM markers (mmol/L) .
Time frame: From enrollment to day 30