Effect of Science Research Wellness Ndo1 on Glycaemia in Adults With Pre-diabetes

Wellizen Australia

Status: Enrolling

Conditions: Prediabetes

Treatments: Dietary Supplement: SRW Ndo1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06897462

WEL202401

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

SRW Ndo1

Experimental group

Description:

Active arm The investigational product (IP) is a health supplement that contains 80 mg of dahlia4® (Dahlia pinnata extract), 80 mg of Eriomin® (Citrus limon extract), and 100 mg of Mulberry leaf extract (with 5% 1-deoxynojirimycin) per capsule. Excipients include Microcrystalline cellulose, Magnesium stearate, and Colloidal silicon dioxide. Participants will take two capsules of Ndo1 per day, before dinner, with water, for 12 weeks.

Treatment:

Dietary Supplement: SRW Ndo1