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

Immunomodulatory, oxidative damage protection and genomic stability effects of bovine colostrum-enriched skim milk supplementation in older adults subjects: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15330940

Enrollment

Registered

2023-07-13

Start date

2021-11-27

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Promotion of healthy ageing in older adults Not Applicable

Interventions

The treatment use for this study is bovine colostrum-enriched skim milk, which contains 150 mg of IgG in each sachet (15 g) in the form of pasteurized milk powder. The investigational product is prepa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Community-dwelling older adults aged 50 - 69 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 2. Antioxidant and oxidative stress status is measured by mean plasma MDA levels and SOD activities at baseline and 12 weeks after intervention commencement. 3. Genomic stability is measured by mean plasma 8-OHdG and telomerase levels at baseline and 12 weeks after intervention commencement.	—

Measure

Time frame

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. 2. Antioxidant and oxidative stress status is measured by mean plasma MDA levels and SOD activities at baseline and 12 weeks after intervention commencement. 3. Genomic stability is measured by mean plasma 8-OHdG and telomerase levels at baseline and 12 weeks after intervention commencement.

—

Secondary

Measure	Time frame
1. Changes in body mass index (kg/m²), waist and hip circumferences (cm) at baseline and 12 weeks after intervention commencement. 2. Cognitive function measured by MMSE, RAVLT, digit symbol and digit span tests questionnaires at baseline and 12 weeks after intervention commencement. 3. Physical fitness measured using handgrip dynamometer and timed up and go test at baseline and 12 weeks after intervention commencement. 4. Quality of life measured using WHOQOL-BREF questionnaire at baseline and 12 weeks after intervention commencement. 5. Blood pressure measured using blood pressure monitor at baseline and 12 weeks after intervention commencement. 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.	—

Measure

Time frame

1. Changes in body mass index (kg/m²), waist and hip circumferences (cm) at baseline and 12 weeks after intervention commencement. 2. Cognitive function measured by MMSE, RAVLT, digit symbol and digit span tests questionnaires at baseline and 12 weeks after intervention commencement. 3. Physical fitness measured using handgrip dynamometer and timed up and go test at baseline and 12 weeks after intervention commencement. 4. Quality of life measured using WHOQOL-BREF questionnaire at baseline and 12 weeks after intervention commencement. 5. Blood pressure measured using blood pressure monitor at baseline and 12 weeks after intervention commencement. 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.

—

Countries

Malaysia

Contacts

Public ContactTheng Choon Ooi

ooithengchoon@ukm.edu.my+60-392897459

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026