The effects of 12 weeks of bovine colostrum-enriched skim milk supplementation on immune function, antioxidant status and genomic stability in older adults

Not Applicable

Completed

• Conditions: Promotion of healthy ageing in older adults; Not Applicable

• Registration Number: ISRCTN15330940
• Lead Sponsor: SNI SDN BHD

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37513601/ (added 05/08/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-05-10
• Study Start: 2023-07-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Community-dwelling older adults aged 50 - 69 years

Exclusion Criteria

1. Current or past history of cancer or on chemotherapeutic regiment
2. Subjects allergic/intolerance to dairy products
3. Subjects with chronic kidney diseases/kidney failure
4. Subjects with uncontrolled hypertension or diabetes
5. Subjects with heart or cardiovascular disease
6. Lactating and pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Immunomodulatory effects is assessed by immunophenotyping (CD markers) and mean plasma IL-6, IL-10, TNF-alpha and CRP levels at baseline and 12 weeks after intervention commencement.<br>2. Antioxidant and oxidative stress status is measured by mean plasma MDA levels and SOD activities at baseline and 12 weeks after intervention commencement.<br>3. Genomic stability is measured by mean plasma 8-OHdG and telomerase levels at baseline and 12 weeks after intervention commencement.

Secondary Outcome Measures

Name	Time	Method
1. Changes in body mass index (kg/m²), waist and hip circumferences (cm) at baseline and 12 weeks after intervention commencement.<br>2. Cognitive function measured by MMSE, RAVLT, digit symbol and digit span tests questionnaires at baseline and 12 weeks after intervention commencement.<br>3. Physical fitness measured using handgrip dynamometer and timed up and go test at baseline and 12 weeks after intervention commencement.<br>4. Quality of life measured using WHOQOL-BREF questionnaire at baseline and 12 weeks after intervention commencement.<br>5. Blood pressure measured using blood pressure monitor at baseline and 12 weeks after intervention commencement.<br>6. Fasting blood glucose, lipid profile, liver function test, renal function test, hematology profile, vitamin D and calcium levels measured by accredited medical laboratory testing at baseline and 12 weeks after intervention commencement.