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NCT Number: NCT07690735

Investigation 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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrilite Glucose health herbal drink

Dietary Supplement

1 sachet per time, 3 times a day after meal

Placebo drink

Dietary Supplement

1 sachet per time, 3 times a day after meal

Primary outcomes

  1. Changes in blood glucose level（fasten plasma glucose）

    Time frame: baseline day 0, day 56

    fasten plasma glucose

  2. Changes in blood glucose level (2-hour postprandial blood glucose levels)

    Time frame: baseline day 0, day 56

    2-hour postprandial blood glucose levels

Secondary outcomes

  1. changes of glycated hemoglobin

    Time frame: baseline day 0, day 56

    HbA1c level

  2. Changes in islet function (insulin level)

    Time frame: baseline day 0, day 56

    insulin level

  3. changes in islet function (C-peptide level)

    Time frame: baseline day 0, day 56

    C-peptide level

  4. Changes in blood lipids profile (TC)

    Time frame: baseline day 0, day 56

    Total cholesterol

  5. Changes in blood lipids profile (TG)

    Time frame: baseline day 0, day 56

    total triglycerides

  6. Symptom observation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amway (China) R&D Center

Industry

Collaborators

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Registry information

Official study title

A Randomized, Double-blind Controlled Trial to Investigate the Effects of Nutrilite Glucose Health Herbal Drink on Prediabetes Persons

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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