A Study to Assess the Gut Health Effects of Heat-killed Post-biotics in Overweight and Obese Adults

Inclusion Criteria:

• Male and female individuals with the age ≥18 and ≤45 years with active lifestyle,moderate physical activity level as per International Physical ActivityQuestionnaire - Short Form (IPAQ-SF - SF)

• BMI of ≥ 25 - ≤ 35 kg/m2

• Individuals with liver & renal function test values as defined below:

1. Individuals with ALT, AST values ≤ 2 times of the upper limit of normal (ULN).

2. Individuals with creatinine values ≤ 1.5 times of the upper limit of normal (ULN).

3. Individuals with ALP values ≥ 38 and ≤ 126 U/L

• Having at least two of the following five metabolic risk factors:

1. Waist circumference > 102 cm (40 inches) for men and > 88 cm (35 inches) forwomen

2. Fasting triglycerides >150 mg/dL and < 300 mg/dl

3. Blood pressure ≥130 mm Hg (Systolic Blood Pressure) and/or ≥85 mm Hg (DiastolicBlood Pressure)

4. Fasting blood glucose ≥ 100 mg/ dl

5. Fasting HDL cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women)

• History of mild to moderate gastrointestinal discomfort for at least last threemonths

• Individuals experiencing moderate-intensity gastrointestinal symptoms, evaluatedbased on the combined scores of two GSRS domains (dyspeptic syndrome and boweldysfunction), falling within the range of ≥ 15 and ≤ 29 over the past two weeks. (The highest score out of two weeks' GSRS scores will be taken into considerationfor the study)

• Willing to complete all study procedures including study-related questionnaires andcomply with study requirements.

• Willing to abstain from other supplements or medication.

• Ready to give voluntary, written, informed consent to participate in the study

• No prohibited antibiotic usage within the last 30 days.

• History of stable weight over the last 6 months (<10% change)

• Willing to maintain current dietary and exercise habits, aside from any changes tobe made per the study exercise protocol

Randomization Criteria:

• Two weeks of run - in period for weight stability (Weight instability defined as > 2kg of weight gain or loss over 2 weeks of run-in period)

• GSRS scores not less than that reported at screening. (The highest score out of twoweeks' GSRS scores will be taken into consideration for the study)

• Both the weekly at-home diaries for GSRS should be available

• 80% compliance to the run-in medication

Exclusion Criteria:

• Individual who smokes and consumes tobacco regularly.

• Presence of unstable, acutely symptomatic, or life-limiting illness.

• Individuals diagnosed with diabetes and are on active medication

• FBG > 125 mg/dl

• Individuals diagnosed with hypertension and are on active medication.

• Individuals with uncontrolled hypertension with systolic blood pressure ≥150and/or diastolic blood pressure ≥100 mm Hg.

• Individuals with neurological conditions causing functional or cognitiveimpairments.

• Individuals with a history or presence of clinically significant renal,hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologicdisorders that, in the judgment of the Investigator, would interfere with thesubject's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put thesubject at undue risk.

• Individuals under use of any psychotropic medication within four weeks ofscreening and throughout the study

• Individual under use of antibiotics or signs of active systemic infection at thetime of screening. Treatment visits will be rescheduled to allow the subject to washoff the antibiotic for at least five days prior to any test visit

• Individual states they regularly consume supplemental enzymes and are unwilling tostop at least one week prior to screening and throughout the study. Supplementalenzymes may include standalone enzyme supplements, probiotic supplements withenzymes, and any medications containing enzymes.

• Individuals states they regularly consume probiotic supplements and areunwilling to stop at least one week prior to screening and throughout thestudy. Supplemental probiotics may include standalone probiotic supplements,vitamins with probiotics, and any foods supplemented with probiotics

• Exposure to any non-registered drug product within 3 months prior to thescreening visit.

• Unable/unwillingness to complete study specific diaries (digital/paper-based).

• Current use of the following medications: monoamine oxidase inhibitors,prescription or herbal weight loss medications/ dietary supplement.

• Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives.

• Individual who reports alcohol intake as average of 3 or more servings per day

18. Individuals with thyroid dysfunction as assessed by TSH ≤ 0.4 or ≥ 4.3mIU/L.

• Individuals state they have an allergy or intolerance to any ingredient in the studyproduct or test meal.

• Individual is deemed unsuitable for study based upon study physicianassessment.

• Individual is taking part in another clinical trial