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

NCT ID: NCT06417840

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-22
• Study Completion Date: 2024-10-30

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

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Control

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: DIETARY_SUPPLEMENT

Placebo Control

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Control

Placebo Control

Intervention Type: DIETARY_SUPPLEMENT

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brightseed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Diabetes Foundation (India)

New Delhi, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Anoop Misra, PhD

Role: CONTACT

anoopmisra@gmail.com

91-11-41759672

Facility Contacts

Anoop Misra, PhD

Role: primary

anoopmisra@gmail.com

91-11-41759672

Other Identifiers

1.4/FCDOC/EC/HAO/2024-25

Identifier Type: -

Identifier Source: org_study_id