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

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Dietary supplement: Nutrilite Glucose health herbal drink; Dietary supplement: Placebo drink

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo drink	Dietary supplement: Placebo drink; 1 sachet per time, 3 times a day after meal
Experimental: nutrilite glucose health herbal drink	Dietary supplement: Nutrilite Glucose health herbal drink; 1 sachet per time, 3 times a day after meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Amway (China) R&D Center
• Collaborators: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 8, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Prediabetic State
• Other Study ID Numbers: IS20220010RDBJSP02V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No