Effects of a Probiotic Supplement on Blood Sugar and Gut Health in Adults with Prediabetes, Diabetes, and Diabetes with Obesity

Not Applicable

Recruiting

• Conditions: Health Condition 1: - Health Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2024/07/070100
• Lead Sponsor: Dr. Reddy’s Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Type of Participant and Disease Characteristics

1 General Criteria for all categories

Male and Female subjects with age 18 years to 55 years both inclusive

Are willing to sign the informed consent and adhere to the study protocol for the duration of the study

2 Pre-diabetics

HbA1c in the range of 5.7 to less than or equal to 6.4 percentage

FBG in the range 110 to 125 mg per dl or PPG in the range 140 to199 mg per dl

With BMI greater than or equal to 18.5 to 28.0

3 Diabetics

HbA1c greater than or equal 6.5 to less than or equal to 9 percentage

FBG greater than or equal 126 mg per dl or PPG greater than or equal 200 mg per dl

With normal BMI in the range greater than or equal to 18.5 to less than or equal to 24.9

Before entry into the study and throughout in study the subject should be on stable antidiabetic medication for at least 12 weeks

4 Diabetics plus Obesity

HbA1c greater than or equal to 6.5 to less than or equal to 9 percentage

FBG greater than or equal 126 mg per dl or PPG greater than or equal 200 mg per dl

With BMI greater than or equal to 25

Before entry into the study and throughout in study the subject should be on stable antidiabetic medication for at least 12 weeks

5 Healthy

HbA1c less than 5.7 percentage

FBG greater than or equal 110 mg per dl or PPG greater than or equal 140 mg per dl

With BMI in the range greater than or equal to 18.5 to less than or equal to 24.9

Healthy subjects with no ongoing comorbidities

Exclusion Criteria

Medical Conditions and Prior medication

Type 1 diabetes mellitus

Concomitant autoimmune disorders, liver conditions, gastrointestinal disorders (i.e., irritable bowel syndrome, inflammatory bowel disease and coeliac disease etc.), GI injury or any other GI disorder that can interfere with absorption etc of the pro-prebiotic supplement.

Recent use (within the previous 8 weeks of date of Informed Consent Form) of antibiotics, steroids and dietary supplements (fish oil, probiotics, prebiotics, multivitamins, minerals, nutraceuticals and herbal preparations)

Pregnancy, breastfeeding or planning to become pregnant

Alcohol abuse or the use of any illicit drugs

Clinical evidence of active infection or any severe illness unrelated to diabetes.

Any other condition in the opinion of a Principal Investigator which may interfere with study results and affects the subject safety.

Diabetes or Diabetes plus Obesity subjects on insulin or Alpha Glucoside Inhibitors

Prediabetic subjects on metformin

Subjects on weight loss diets or taking any sort of supplements for weight loss

Patients with history of or any ongoing food allergies or any other allergies

Subjects eating outside food (ie from hotels/mess etc) less than or equal to4 times in a week

Subjects who are settled in a region or migrated from north or east region of India

People whose daily diet is too light or too greasy are not recommended to participate in the test

Subject who are Lactose or Gluten or casein intolerant

No oral poisoning to the individual

No ongoing Immunosuppressive Medications and such other treatments

No diarrhea, fever or other clear inflammatory reactions within the last one week of date of ICF

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For Pilot Phase: <br/ ><br>To study the effect of pro-prebiotic formulation on the FBG <br/ ><br> <br/ ><br>For Exploratory Phase: <br/ ><br>To study the effect of pro-prebiotic formulation on the FBG <br/ ><br>Timepoint: For Pilot Phase: <br/ ><br>To estimate the trend in change in FBG from baseline to 1 month [Time Frame: Baseline, 30 days] <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>For Exploratory Phase: <br/ ><br>To estimate the change in FBG of the test arm in comparison to the standard control [Time Frame: Baseline to 90 days]