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NCT Number: NCT06417840

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

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.

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fasting Blood Glucose between 100-125 mg/dL;
  • and BMI range 25-30 kg/m2;
  • and waist circumference ≥80cm for women and ≥90cm for men;

Exclusion criteria

  • Weight loss or gain ≥4.5 kg within 90 days of visit 1.
  • Use of weight loss medications within 90 days of visit 1.
  • History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
  • 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.
  • History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
  • History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
  • Current medical diagnosis of type 1 or type 2 diabetes mellitus.
  • HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
  • History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
  • 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.
  • 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.
  • 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.
  • Excessive alcohol consumption (> 2 Drinks, 60 ml of Whisky Per Day).

Treatment and study plan

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

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.

Placebo Control

Dietary Supplement

Placebo Control

Primary outcomes

  1. Fasting Blood Glucose

    Time frame: 0, and 28 days

    Blood Glucose Concentration mg/dL

Secondary outcomes

  1. Fasting Blood Insulin

    Time frame: 0, and 28 days

    Blood Insulin Concentration mcIU/mL

  2. HbA1c

    Time frame: 0, and 28 days

    Percent (%) blood HbA1c level

  3. Continuous Glucose Monitoring

    Time frame: 0, and 28 days

    Continuous Blood Glucose Monitoring mg/dL

  4. Total Cholesterol

    Time frame: 0, and 28 days

    Total blood cholesterol mg/dL

  5. Low-density lipoprotein (LDL) cholesterol

    Time frame: 0, and 28 days

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

  6. High-density lipoprotein (HDL) cholesterol

    Time frame: 0, and 28 days

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

  7. Triglycerides

    Time frame: 0, and 28 days

    Blood Triglycerides mg/dL

  8. Weight

    Time frame: 0, and 28 days

    kg of Body Weight

  9. Height

    Time frame: 0, and 28 days

    Height in meters (m)

  10. Body Mass Index (BMI)

    Time frame: 0, and 28 days

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

  11. Waist Circumference

    Time frame: 0, and 28 days

    Waist Circumference in cm

Study contacts

Contact information is provided by the study sponsor or research team.

Anoop Misra, PhD

CONTACT

[email protected]

91-11-41759672

Sponsors and collaborators

Lead sponsor

Brightseed

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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