To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes

PreDiabetes Clinical Trial

Official title:

To Evaluate the Impact of Consumption of a Bioactive Compound Extracted From Fermented Yeast on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes: A Randomized, Double Blinded, Placebo-controlled Parallel Arm Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417840
• Other study ID #: 1.4/FCDOC/EC/HAO/2024-25
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: Brightseed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. At the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables.

The measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), HbA1c and lipid profile.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Fasting Blood Glucose between 100-125 mg/dL;

2. and BMI range 25-30 kg/m2;

3. and waist circumference =80cm for women and =90cm for men;

Exclusion Criteria:

1. Weight loss or gain =4.5 kg within 90 days of visit 1.

2. Use of weight loss medications within 90 days of visit 1.

3. History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.

4. Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.

5. History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.

6. History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.

7. Current medical diagnosis of type 1 or type 2 diabetes mellitus.

8. HbA1c =48 mmol/mol (6.5%) as measured at visit 1.

9. History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).

10. Signs or symptoms of an active infection of clinical relevance within 5 days of visit

1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 days prior to visit 1.

11. Is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.

12. Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

13. Excessive alcohol consumption (> 2 Drinks, 60 ml of Whisky Per Day).

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)
N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT) derived via synthetic biology (i.e., fermentation using a recombinant microorganism) to provide a high purity (>85%) form of these compounds that are structurally identical to their naturally occurring counterparts. All ingredients in the encapsulated final test article, including the NCT and NFT, are manufactured under food GMPs and are of suitable quality for use in food, dietary supplements, and specialty nutrition products.
• Placebo Control
Placebo Control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brightseed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting Blood Glucose	Blood Glucose Concentration mg/dL	0, and 28 days
Secondary	Fasting Blood Insulin	Blood Insulin Concentration mcIU/mL	0, and 28 days
Secondary	HbA1c	Percent (%) blood HbA1c level	0, and 28 days
Secondary	Continuous Glucose Monitoring	Continuous Blood Glucose Monitoring mg/dL	0, and 28 days
Secondary	Total Cholesterol	Total blood cholesterol mg/dL	0, and 28 days
Secondary	Low-density lipoprotein (LDL) cholesterol	Blood Low-density lipoprotein (LDL) cholesterol mg/dL	0, and 28 days
Secondary	High-density lipoprotein (HDL) cholesterol	Blood High-density lipoprotein (HDL) cholesterol mg/dL	0, and 28 days
Secondary	Triglycerides	Blood Triglycerides mg/dL	0, and 28 days
Secondary	Weight	kg of Body Weight	0, and 28 days
Secondary	Height	Height in meters (m)	0, and 28 days
Secondary	Body Mass Index (BMI)	Body mass index (BMI) measured via weight in kilograms divided by the square of height in meters.	0, and 28 days
Secondary	Waist Circumference	Waist Circumference in cm	0, and 28 days