## Protocol Section
### Identification Module
**NCT ID:** NCT06417840

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

**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

#### Organization Study ID Info
**ID:** 1.4/FCDOC/EC/HAO/2024-25
#### Organization
**Class:** INDUSTRY
**Full Name:** Brightseed
### Status Module
#### Completion Date
**Date:** 2024-10-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-22

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Brightseed

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- PreDiabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 130

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Dietary Supplement: Placebo Control

**Label:** Placebo Control

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Dietary Supplement: N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)

**Label:** N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)

**Description:** 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.

**Name:** N-trans-caffeoyltyramine (NCT) and N-trans-feruloyltyramine (NFT)

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo Control

**Description:** Placebo Control

**Name:** Placebo Control

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Blood Glucose Concentration mg/dL

**Measure:** Fasting Blood Glucose

**Time Frame:** 0, and 28 days

#### Secondary Outcomes

**Description:** Blood Insulin Concentration mcIU/mL

**Measure:** Fasting Blood Insulin

**Time Frame:** 0, and 28 days

**Description:** Percent (%) blood HbA1c level

**Measure:** HbA1c

**Time Frame:** 0, and 28 days

**Description:** Continuous Blood Glucose Monitoring mg/dL

**Measure:** Continuous Glucose Monitoring

**Time Frame:** 0, and 28 days

**Description:** Total blood cholesterol mg/dL

**Measure:** Total Cholesterol

**Time Frame:** 0, and 28 days

**Description:** Blood Low-density lipoprotein (LDL) cholesterol mg/dL

**Measure:** Low-density lipoprotein (LDL) cholesterol

**Time Frame:** 0, and 28 days

**Description:** Blood High-density lipoprotein (HDL) cholesterol mg/dL

**Measure:** High-density lipoprotein (HDL) cholesterol

**Time Frame:** 0, and 28 days

**Description:** Blood Triglycerides mg/dL

**Measure:** Triglycerides

**Time Frame:** 0, and 28 days

**Description:** kg of Body Weight

**Measure:** Weight

**Time Frame:** 0, and 28 days

**Description:** Height in meters (m)

**Measure:** Height

**Time Frame:** 0, and 28 days

**Description:** Body mass index (BMI) measured via weight in kilograms divided by the square of height in meters.

**Measure:** Body Mass Index (BMI)

**Time Frame:** 0, and 28 days

**Description:** Waist Circumference in cm

**Measure:** Waist Circumference

**Time Frame:** 0, and 28 days

### Eligibility Module

**Eligibility Criteria:** 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).

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14117

- Name: Prediabetic State

- Relevance: HIGH

- As Found: Pre-diabetes

- ID: M20295

- Name: Glucose Intolerance

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011236

- Term: Prediabetic State

### Misc Info Module

- Version Holder: 2024-05-31
