A clinical study to check the Safety, Tolerability and Sensory Evaluation of Baby foods Ã¢â?¬â?? wheat variant

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Adult population:

1.Healthy adult subjects of either sex aged between 18 to 50 years.

2.Subjects willing to refrain taking any other similar products during the study period

3.Adult subjects who have not participated in this kind of trial in the past 4 weeks

4.Adult subjects willing to sign informed consent and follow the study procedure.

Children and babies Population:

1.Healthy male and female subjects aged between 6months to 12 years depends on the groups.

2.Parents/Guardians/Caregiver related to subjects < 7 years willing to give informed consent for his/her child to participate in the study.

3.Subjects aged > 7 years of age willing to provide oral consent for his/her participation in the study along with parents/guardians/caregiver consent (Refer protocol section 11.4, Informed Consent Process)

4.Subjects not using similar products during the study period.

5.Subjects willing to refrain taking any other similar products during the study period

6.Subjects who have not participated in this kind of trial in the past 4 weeks.

7.Parents/ Guardians/ Caregivers of the subjects willing to sign informed consent/assent (as applicable) and follow the study procedure.

Exclusion Criteria

1.Subjects with clinically significant serious cardiovascular, respiratory,

cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.

2.A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.

3.Pre-existing systemic disease necessitating long-term medications.

4.Subjects who refused to sign informed consent.

5.Pregnant and lactating women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Safety, Tolerability, and sensory evaluation of Baby foods - wheat variant in study population <br/ ><br>2. The study evaluate the incidence of adverse events in study population. <br/ ><br>the study is conducted in 3 groups, Group A: 18-50years, Group B: 2-12 years and Group C: 6months to 24 months babiesTimepoint: Baseline/ Day 1 <br/ ><br>Day 7 (end of week 1)

Secondary Outcome Measures