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| Name | Class |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Sun Yat-sen University | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visualization (intervention arm, group A) | Experimental | CGM feedback visualization |
|
| Blinded Visualization (control arm, group B) | Placebo Comparator | blinded for CGM feedback visualization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM feedback visualization | Other | The subject will have CGM feedback visualization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Likert-scale for perceived benefit | A Likert-scale from 1 (very unlikely) to 7 (very likely) on perceived product benefits | From enrollment to day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Likert-scale for product experience | A Likert-scale from 1 (very unlikely) to 7 (very likely) on product experience. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term glucose metabolism -HbA1c | HbA1c (%) changes | From day 0 to day 88 |
| International physical activity questionnaire | Changes in physical activity levels captured via the International physical activity questionnaire (IPAQ), category: low, moderate, high |
Inclusion Criteria:
Willing and able to understand and sign a written informed consent prior to study entry
Deemed able to comply with the requirements of the study protocol and consume study product
BMI: 18.5-35.0 kg/m2 (inclusive)
Age: 45-75y (inclusive 45 and 75)
Males and females
HbA1c ≤ 6.4 % and FPG ≤ 6.90 mmol/L (125 mg/dl) to exclude diabetic individuals based on the National Institute of Health and Care (NICE) criteria
Regularly consuming a carbohydrate containing breakfast (≥30g of total CHO) assessed by a food recall only at breakfast of the previous day to the screening visit
Having a sedentary lifestyle meaning do not usually conduct vigorous*-intense physical activity and are willing to abstain from it during reference and intervention period
If on chronic medication such as lipid-lowering, thyroid medication, etc., the dosage must be constant for at least 3 months prior to screening.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| milk supplemented with mulberry leaves extract | Dietary Supplement | milk supplemented with mulberry leaves extract |
|
| blinded CGM feedback visualization | Other | The subject will have blinded CGM feedback visualization |
|
| 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.
| 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) . | From enrollment to day 30 |
| CGM markers - 24h iAUC | Changes in CGM markers. (mmol/L x min) | From enrollment to day 30 |
| CGM markers - iCmax | Changes in CGM markers in response to IP intake (mmol/L) . | From enrollment to day 30 |
| CGM markers - Tmax | Changes in CGM markers in response to IP intake (min). | From enrollment to day 30 |
| CGM markers - time in range (TIR) | Changes in CGM markers (%). | From enrollment to day 30 |
| CGM markers - average interstitial glucose | Changes in CGM markers (mmol/L). | From enrollment to day 30 |
| CGM markers - coefficient of variance (CV) | Changes in CGM markers (%) . | From enrollment to day 30 |
| CGM markers - mean amplitude of glycaemic excursion (MAGE) | Changes in CGM markers (mmol/L) . | From enrollment to day 30 |
| From enrollment to day 88 |
| Macronutrient and energy intake | Changes in dietary intake measured using 3-day-food diaries | From enrollment to day 88 |
| Actual changes in perceived change in lifestyle | Actual changes in perceived change in lifestyle will be measured by answering questions: 1 Do you feel that continuous glucose monitor use contributed to you making changes for a healthier lifestyle? (Yes/No/Not sure) 2. After continuous glucose monitor use, do you feel that you changed your diet by limiting or including certain foods? (Yes/No/Not sure) 3. Do you think continuous glucose monitor use made you more likely to be more active/increase your exercise? (Yes/No/Not sure) | From enrollment to day 88 |
| App usage - App screen time | Understanding of the app usage will be measured throughout the intervention period with metric of App screen time | From enrollment to day 30 |
| Long-term glucose metabolism -fasting plasma glucose | fasting plasma glucose (mmol/L) changes | From day 0 to day 88 |
| Long-term glucose metabolism -insulin levels | insulin levels ( μU/mL) changes | From day 0 to day 88 |
| Long-term glucose metabolism -HOMA-IR | HOMA-IR (numerical index) changes | From day 0 to day 88 |
| lipid metabolism changes - HDL-C | HDL-C (mmol/L) changes | From day 0 to day 88 |
| lipid metabolism changes - LDL-C | LDL-C(mmol/L)changes | From day 0 to day 88 |
| lipid metabolism changes -Total cholesterol | Total cholesterol (mmol/L) changes | From day 0 to day 88 |
| lipid metabolism changes - Triglycerides | Triglycerides(mmol/L)changes | From day 0 to day 88 |
| Weight outcomes changes - waist circumference | waist circumference(cm)changes | From day 0 to day 88 |
| Weight outcomes changes - BMI | weight and height will be combined to report BMI in kg/m^2 , and the changes of BMI. | From day 0 to day 88 |
| Weight outcomes changes - Body weight, | Body weight (kg) changes | From day 0 to day 88 |
| App usage - numbers of log per days | Understanding of the app usage will be measured throughout the intervention period with metric of number of log per days. | From enrollment to day 30 |
| D004700 | Endocrine System Diseases |