Investigation of Nutrilite Glucose Health Herbal Drink on Prediabetes Persons
A Randomized, Double-blind Controlled Trial to Investigate the Effects of Nutrilite Glucose Health Herbal Drink on Prediabetes Persons
1 other identifier
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2023
CompletedStudy Start
First participant enrolled
December 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
CompletedFirst Posted
Study publicly available on registry
July 8, 2026
CompletedJuly 8, 2026
July 1, 2026
2.4 years
November 30, 2023
July 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (6)
changes of glycated hemoglobin
baseline day 0, day 56
Changes in islet function (insulin level)
baseline day 0, day 56
changes in islet function (C-peptide level)
baseline day 0, day 56
Changes in blood lipids profile (TC)
baseline day 0, day 56
Changes in blood lipids profile (TG)
baseline day 0, day 56
- +1 more secondary outcomes
Study Arms (2)
nutrilite glucose health herbal drink
EXPERIMENTALplacebo drink
PLACEBO COMPARATORInterventions
1 sachet per time, 3 times a day after meal
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2023
First Posted
July 8, 2026
Study Start
December 4, 2023
Primary Completion
April 30, 2026
Study Completion
May 30, 2026
Last Updated
July 8, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share