PreDiabetes
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNutrilite Glucose health herbal drink
1 sachet per time, 3 times a day after meal
DIETARY_SUPPLEMENTPlacebo drink
1 sachet per time, 3 times a day after meal
Sponsors
Amway (China) R&D Center
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects, age 18-65 years. * Participants who meet the following diagnostic criteria based on the "Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition)" and "Guiding Principles for Evaluation of Health Food Efficacy": fasting blood glucose levels of \>5.6 and \<7.0 mmol/L, and/or 2-hour postprandial blood glucose levels ≥7.8 and \<11.1 mmol/L. * Participants agree not to take any dietary supplements or foods for blood glucose controlduring the study. * Participants understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.
Exclusion criteria
* Participants diagnosed with type 1 diabetes mellitus. * Malignant diseases: patients with severe lung, cardiovascular, blood and hematopoietic system, central nervous system or other system diseases, as well as tumor patients * Participants who developed diabetic ketosis, acidosis, and infection within the past 3 months. * Participants who participated in other clinical trials within the past 3 months. * Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial; * Participantes who are allergic to the test samples. * PI considers that volunteers cannot fully cooperate with the trial arrangement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood glucose level（fasten plasma glucose） | baseline day 0, day 56 | fasten plasma glucose |
| Changes in blood glucose level (2-hour postprandial blood glucose levels) | baseline day 0, day 56 | 2-hour postprandial blood glucose levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of glycated hemoglobin | baseline day 0, day 56 | HbA1c level |
| Changes in islet function (insulin level) | baseline day 0, day 56 | insulin level |
| changes in islet function (C-peptide level) | baseline day 0, day 56 | C-peptide level |
| Changes in blood lipids profile (TC) | baseline day 0, day 56 | Total cholesterol |
| Changes in blood lipids profile (TG) | baseline day 0, day 56 | total triglycerides |
| Symptom observation | baseline day 0, day 56 | 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. |
Countries
China
Outcome results
None listed