To study the effect of short term lysine(proteins)supplementation in improving muscle function of Indian girls aged 9-10 years.

Not Applicable

Completed

• Registration Number: CTRI/2018/05/013997
• Lead Sponsor: International Life Sciences Institute India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-12-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Willing to give informed consent

2. Subject belongs to middle socio economic background as per modified Kuppuswamy scale.

3. Girls with a habitual dietary lysine intake of 35-40 mg/kg/day, as assessed by the dietary intake.

4. Understands and is willing, able and likely to comply with all study procedures and restrictions.

5. Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

6. Girls residing in the peri-urban areas of Bangalore city.

7. Girls with Z-scores of height for age of 0 to >=-3

8. Girls with mild anemia or no anemia- Hb > 11 g/dL Hb.

Exclusion Criteria

1. Children in Care (CiC)

2. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds)

3. Subjects with moderate/severe anaemia (Hb less than 10.9g %) measured using a Hemocue.

4. Any injury or deformity of the upper limbs making the children incapable of performing the hand dynamometry.

5. Participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit.

6. Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder

7. Recent history (3 months) of serious infections, injuries and/ or surgeries.

8. Children consuming other nutritional supplements and/ or health food drinks on a regular basis

9. An employee of the sponsor or the study site or members of their immediate family.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in the muscle strength, as assessed by hand dynamometer, will be examined between the experimental arm and the control arm.Timepoint: Baseline and endline

Secondary Outcome Measures

Name	Time	Method
Change in hemoglobin levelsTimepoint: baseline and endline