Protein quality assessment of commonly consumed foods

• Register: CTRI
• Last refreshed on: 27 January 2021
• Main ID: CTRI/2019/08/020568
• Date of registration: 06-08-2019
• Prospective Registration: Yes
• Primary sponsor: The Wellcome TrustDBT India Alliance
• Public title: Protein quality assessment of commonly consumed foods
• Scientific title: Assessment of metabolic availability of limiting amino acids from differently processed milk proteins and standard Indian diets using indicator amino acid oxidation (IAAO) technique in humans
• Date of first enrolment: 19-08-2019
• Target sample size: 24
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=25816
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Rebecca Kuriyan
• Affiliation: St Johns Research Institute

• Name: Sulagna Bandyopadhyay
• Affiliation: St Johns Research Institute

Key inclusion & exclusion criteria

Inclusion criteria: 1. BMI between 18.5 to 25 Kg/m²
Exclusion criteria: 1. History of smoking or taking other leisure drugs

2. Consumption of alcohol in the previous 24 hours

3. History of antibiotic usage 4 weeks prior to the study

4. On iron supplementation therapy (3 months)

5. On medication such as NSAIDâ??s, proton pump inhibitors or H2 blockers 2 days prior to and on the study day

6. Participation in any nutritional study in the last 6 months

7. History of food allergy, specifically milk, cereal (ragi/rice/wheat), pulse or meat protein

8. Diagnosed with chronic medical or surgical illness

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Nil: Nil

Primary Outcome(s)

Metabolic availability of limiting amino acids from differently processed milk proteins and standard indian diets in healthy human adultsTimepoint: Subjects will be studied once in a week for 8 weeks. On the day of the experiment breath collection will be performed on half hourly fashion in the initial hours and thereafter in 15 mins interval in last 2 hours.

Time points of breath collection: Baseline and post meal - 30, 60, 90, 120, 180, 210, 240, 300, 315, 330, 345, 360, 375, 390, 405, 420, 435, 450, 465, 480 minutes

Secondary Outcome(s)

To determine true metabolic availability of limiting amino acids from differently processed milk proteins and standard indian diets in healthy human adultsTimepoint: Breath samples will be collected at baseline and post meal 30, 60, 90, 120, 180, 210, 240, 300, 315, 330, 345, 360, 375, 390, 405, 420, 435, 450, 465, 480 minutes

Secondary ID(s)

REF/2018/04/019639

Source(s) of Monetary Support

The Wellcome Trust/DBT India Alliance

Ethics review

Status: Approved
Approval date: 04/05/2018
Contact:

Institutional Ethical Committee