Clinical trial NCT06417840: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Brightseed
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: 0, and 28 days
Secondary outcomes:
measure: Fasting Blood Insulin
timeFrame: 0, and 28 days
measure: HbA1c
timeFrame: 0, and 28 days
measure: Continuous Glucose Monitoring
timeFrame: 0, and 28 days
measure: Total Cholesterol
timeFrame: 0, and 28 days
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: 0, and 28 days
measure: High-density lipoprotein (HDL) cholesterol
timeFrame: 0, and 28 days
measure: Triglycerides
timeFrame: 0, and 28 days
measure: Weight
timeFrame: 0, and 28 days
measure: Height
timeFrame: 0, and 28 days
measure: Body Mass Index (BMI)
timeFrame: 0, and 28 days
measure: Waist Circumference
timeFrame: 0, and 28 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Diabetes Foundation (India)
Study officials:
References: