Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this two arms, randomized, double-blind controlled trial is to study whether Nutrilite herbal drink could ameliorate blood glucose level in prediabetes population.
100 eligible Participants aged 18-65 years will be enrolled in one center. Participants will be randomly assigned to two study groups, with 50 subjects in each group.Study subjects will be administrated with either the Nutrilite product or a placebo drink for two months (8 weeks). And up to three study visits will be made by the subject over a 2-month period intervention.
Researchers will compare two groups to see if consumption of Nutrilite herbal drink could significantly ameliorate blood glucose level at the end of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nutrilite glucose health herbal drink | Experimental |
| |
| placebo drink | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrilite Glucose health herbal drink | Dietary Supplement | 1 sachet per time, 3 times a day after meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in blood glucose level(fasten plasma glucose) | fasten plasma glucose | baseline day 0, day 56 |
| Changes in blood glucose level (2-hour postprandial blood glucose levels) | 2-hour postprandial blood glucose levels | baseline day 0, day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| changes of glycated hemoglobin | HbA1c level | baseline day 0, day 56 |
| Changes in islet function (insulin level) | insulin level | baseline day 0, day 56 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo drink | Dietary Supplement | 1 sachet per time, 3 times a day after meal |
|
| changes in islet function (C-peptide level) | C-peptide level | baseline day 0, day 56 |
| Changes in blood lipids profile (TC) | Total cholesterol | baseline day 0, day 56 |
| Changes in blood lipids profile (TG) | total triglycerides | baseline day 0, day 56 |
| Symptom observation | A clinical symptom scoring scale for abnormal glucose metabolism was formulated with reference to Internal Medicine of Traditional Chinese Medicine. Symptoms were scored by mild, moderate and severe grades. Total scores were recorded before and after the trial food administration to calculate the clinical symptom improvement rate. The main observed clinical symptoms include excessive thirst with frequent drinking, polyphagia with easy hunger, frequent micturition and other related manifestations. | baseline day 0, day 56 |
| D004700 | Endocrine System Diseases |