A Study to Assess Effect of Glucocil® on Metabolic Health... | NCT06496893

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active 1200 mg per soft gel capsule	Active Comparator	Combination of Vitamin B1, B6, B12, D3, Chromium Picolinate, Proprietary Mulberry Leaf Extract, Cinnamon Bark Powder, Gymnema Sylvestre Extract, Insulina (Cissus Sicyoides) Leaf Extract, Alpha Lipoic Acid, Phellodendron Bark Extract (Berberine HCL), Cissus Quadrangularis Extract, Banaba Leaf Extract, & Fish Oil. Two soft gels to be taken with breakfast and two soft gels to be taken with dinner	Dietary Supplement: IP 1200 mg per soft gel capsule
Placebo (Soyabean oil) 1200 mg per soft gel capsule	Placebo Comparator	Two soft gels to be taken with breakfast and two soft gels to be taken with dinner	Dietary Supplement: Placebo Comparator: Placebo 1200 mg per soft gel capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IP 1200 mg per soft gel capsule	Dietary Supplement	Two soft gels to be taken with breakfast and two soft gels to be taken with dinner	Active 1200 mg per soft gel capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cohort 2- (Type 2 diabetes mellitus (T2DM)) To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glycated haemoglobin (HbA1c) in individuals with Type 2 diabetes mellitus (T2DM).	HbA1c reference ranges for prediabetes is between 5.7 to 6.4% for type II diabetes mellitus, it is between 7 to 9%.. For the current study, impaired range of Hba1c from 6.5 to 6.9% shall be consider as prediabetes	Screening visit (The same value will be considered for baseline) and Day 90.

Secondary Outcomes

Measure	Description	Time Frame
Cohort 1- ( Pre-diabetes) To assess the effect of Investigational Product (IP) on blood sugar in Pre-diabetes as assessed by 2-hour plasma glucose level by Oral Glucose Tolerance Test	Oral glucose tolerance tests (OGTT) are used to measure how well the body can process a larger amount of sugar. If the blood sugar measured in the test is above a certain level, this could be a sign that sugar is not being absorbed enough by the body's cells. Diabetes or gestational diabetes might be at the root of this problem.As per American Diabetes Association, OGTT ranges for prediabetes individuals is 140 mg/ dL to 199 mg/dL and more than 200 mg/dl is considered as type II diabetes mellitus

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females of age more than equal to 30 years and less than equal to 70 years.
Body mass index within 30 kg/m2 and 35 kg/m2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).
Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg/dL to 199 mg/dL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg/dL to 125 mg/dL).
Cohort 2 (T2DM)- Individuals newly diagnosed with Type 2 diabetes mellitus with HbA1c between 7% and 9% (both values included) and fasting blood glucose level in between 126 to 180 mg/dL.
Triglycerides between 150 mg/dL and 299 mg/dL (both values inclusive) and/or Low-Density Lipoprotein (LDL) in between 130 mg/dL and 189 mg/dL (both values inclusive).
Individuals having non-vegetarian diet for at least 2 days a week.
Non-smoker.
Individuals who are willing to not change their physical activity levels throughout the study period.
Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
Individuals ready to give voluntary, written informed consent to participate in the study.

Exclusion Criteria:

Individuals who are exclusively vegetarians diet.
Individuals with Type 1 diabetes mellitus.
Individuals with Type 2 diabetes mellitus on medication.
Individuals with any other endocrine disorder.
Individuals who are currently on diuretics or thyroid supplements
Individuals on lipid-lowering therapies.
Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140/90 mmHg).
Individuals who are currently on antihypertensive medication.
Individuals with cardiac arrhythmia, impaired hepatic or renal function
Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.
History of malignancy or stroke.
Chronic alcoholism: History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by i.For men consuming more than 4 drinks on any day or more than 14 drinks/week ii. For women, consuming more than 3 drinks on any day or more than 7 drinks/week
Individuals taking concomitant medication known to alter blood sugar.
Individuals having treatment with herbal or any other supplements.
Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.
Use of another investigational product within 3 months of the screening visit.
Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives

Name	Role	Phone	Extension	Email
Dr. Shalini Srivastava,, MBBS, MD	Contact	7738418890		shalini.s@vediclifesciences.com
Lalit Pawaskar, M.Pharm, PGDM	Contact	7738418890		lalit.p@vediclifesciences.com

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases