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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Dietary supplement: Placebo Control; Dietary supplement: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control	Dietary supplement: Placebo Control; Placebo Control
Experimental: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Glucose	Blood Glucose Concentration mg/dL	0, and 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Blood Insulin	Blood Insulin Concentration mcIU/mL	0, and 28 days
HbA1c	Percent (%) blood HbA1c level	0, and 28 days
Continuous Glucose Monitoring	Continuous Blood Glucose Monitoring mg/dL	0, and 28 days
Total Cholesterol	Total blood cholesterol mg/dL	0, and 28 days
Low-density lipoprotein (LDL) cholesterol	Blood Low-density lipoprotein (LDL) cholesterol mg/dL	0, and 28 days
High-density lipoprotein (HDL) cholesterol	Blood High-density lipoprotein (HDL) cholesterol mg/dL	0, and 28 days
Triglycerides	Blood Triglycerides mg/dL	0, and 28 days
Weight	kg of Body Weight	0, and 28 days
Height	Height in meters (m)	0, and 28 days
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
Waist Circumference	Waist Circumference in cm	0, and 28 days

Collaborators and Investigators

• Sponsor: Brightseed

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 1.4/FCDOC/EC/HAO/2024-25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No