Clinical study of nutritional supplement Supply6 360 to improve gut health.

A pilot clinical study to evaluate the safety and effectiveness of nutritional supplement Supply6 360 in improving gastrointestinal health and wellness. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063507

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Supply6 360 pack: Dissolve 10 grams one pack into 120 ml room temperature water. Mix well and consume before breakfast in the morning for 60 days. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy male and females between 25-35 years of age both inclusive. 2.BMI between 18.5 – 29.9 kg/m2. 3.Subjects should self-report at least two of the following gastrointestinal symptoms: epigastric discomfort, heartburn, bloating, nausea, fullness in the stomach, abdominal pain, or anorexia. 4.Not consuming probiotics, prebiotics, etc. 5.Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.

Exclusion criteria

Exclusion criteria: 1.Participants with major abdominal surgery a history of inflammatory bowel disease or diverticular disease celiac disease allergic diseases including asthma psychiatric disorders and critical systemic illness as assessed by medical history appropriate consultations and laboratory tests 2.Actively having a gut infection 3.History of or complications from malignant tumors 4.Females who are pregnant and have a positive urine pregnancy test planning to be pregnant/lactating or not using reliable methods of contraception 5.Participants with heavy alcohol consumption or smoking or tobacco consumption 6.Any condition that could in the opinion of the investigator preclude the participants ability to complete the study or that may confound study outcomes.

Design outcomes

Primary

Measure	Time frame
Changes in the Gastrointestinal Symptom Rating Scale (GSRS) scoreTimepoint: From screening visit to end of the study	—

Secondary

Measure	Time frame
1.Changes in lipid profile. 2.Changes in serum vitamin B12 and vitamin D3 levels. 3.Changes in fatigue severity score. 4.Changes in the levels of NAD+ (by ELISA) as an indicator of energy. 5.Percent responders to a reduction in requirement of rescue medication for gastric symptoms (at least 50% reduction in doses or medication events in a month). 6.Gut microbiota assessment.Timepoint: From screening visit to end of the study	—

Measure

Time frame

1.Changes in lipid profile. 2.Changes in serum vitamin B12 and vitamin D3 levels. 3.Changes in fatigue severity score. 4.Changes in the levels of NAD+ (by ELISA) as an indicator of energy. 5.Percent responders to a reduction in requirement of rescue medication for gastric symptoms (at least 50% reduction in doses or medication events in a month). 6.Gut microbiota assessment.Timepoint: From screening visit to end of the study

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Countries

India

Contacts

Public ContactMr Vaibhav Bhandari

Mprex Healthcare Pvt. Ltd.

clinical@mprex.in8554912644

Outcome results