NCT07690735

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

November 30, 2023

Last Update Submit

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

EXPERIMENTAL
Dietary Supplement: Nutrilite Glucose health herbal drink

placebo drink

PLACEBO COMPARATOR
Dietary Supplement: Placebo drink

Interventions

1 sachet per time, 3 times a day after meal

nutrilite glucose health herbal drink
Placebo drinkDIETARY_SUPPLEMENT

1 sachet per time, 3 times a day after meal

placebo drink

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

Locations