Clinical trial NCT06897462: Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes
Official title: Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes
Keywords: Diabetes
prediabetes
Lead sponsor: Wellizen Australia
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to test the effect of 12 weeks of supplementation SRW Ndo1 on metabolic health and general health in adults with prediabetes. The primary question it aims to answer are:

* How does SRW Ndo1 affect the Haemoglobin A1C (HbA1C) test outcome for adult individuals?
* How does SRW Ndo1 affect the body measures and blood pressures of adult individuals?

Investigators will compare the supplement to a placebo (a look-alike substance that contains no supplement) to see if SRW Ndo1 works to support normal blood sugar metabolism.

Participants will:

* Take supplement SRW Ndo1, two capsules a day for 12 weeks.
* Be asked to refrain from changing their diet and lifestyle drastically during the study and to refrain from starting new health supplements during the study.
* Visit the clinic at the start and the end of intervention for a blood test (8 hour fasting required prior to test)
* Keep a diary of their symptoms or adverse events during intervention.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years and over.
2. Prediabetes, defined as fasting plasma glucose of 6.1-6.9 mmol/L and/or HbA1c of 5.7-6.4% and/or 2 h plasma glucose of 7.8-11.0 mmol/L after ingestion of 75 g of oral glucose load. Blood tests conducted within 3 months before randomisation will be accepted.
3. Able to read and write English.
4. Has access to internet.
5. Provided informed consent to participate in the study.

Exclusion Criteria:

1. Has a medical condition known to affect the glycaemia.
2. Regular intake of a health supplement with effects on glycaemia.
3. Currently participating in another trial/study of a supplement or drug.
4. Has any known food or allergy or intolerances to the ingredients of the intervention.
5. Pregnant, trying to conceive or breastfeeding.
6. Has any current substance abuse (including tobacco, alcohol and recreational drugs) or currently in substance withdrawal.
7. Moderate to severe medical conditions (defined as a significant impact on social areas of functioning).
8. Any medical conditions that was not stable over the last 3 months.
9. Taking any prescription medication known to affect glycaemia or had a change in their medication within the last 3 months.
10. Currently taking celiprolol, metformin, or any angiotensin-converting enzyme inhibitor medications.
11. Major medical or surgical event requiring hospitalization within the last 3 months.
12. Any other medical reason that may make participation in this study pose a risk to the participant, including potential herb-drug interactions, at the discretion of the study medical supervisor.

Primary outcomes:
measure: Serum Hemoglobin A1C (HbA1c) concentration
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Fasting plasma glucose concentration
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Weight
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Body Mass Index (BMI)
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Waist circumference
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Blood lipids
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Liver functions test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Hs-CRP test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Systolic and diastolic blood pressure
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Energy questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Hunger and satiety questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Mood questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Gastrointestinal symptoms questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Hypoglycemia events frequency questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Baohua
state: Guandong
Study officials:
References: