Efficacy of human milk supplementation on performance and adaptations
| ISRCTN | ISRCTN50097942 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50097942 |
| Sponsor | GeneChem Inc |
| Funder | GeneChem Inc |
- Submission date
- 21/01/2026
- Registration date
- 26/01/2026
- Last edited
- 23/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Human milk oligosaccharides (HMOs) are abundant in human breast milk and play an essential role in growth and development. For example, the HMO 6’-Sialyllactose (6’-SL) has been reported to possess anti-inflammatory effects and promote immune function, brain development, and gut health. Spadaro et al. reported that 6’-SL administration increased endurance during swimming in a Caenorhabditis elegans model. Recent studies under peer review found that 6’-SL supplementation (oral ingestion of 100 mg/kg for 12 weeks) increased markers of muscle oxidative status and decreased blood lactate during exercise, suggesting a less anaerobic contribution to the exercise task. Additionally, 6’-SL supplementation (100 mg/kg oral ingestion for 12 weeks) increased muscle mass and strength. This proof-of-concept clinical trial aims to determine whether 6’-SL supplementation during resistance training affects exercise performance, body composition, and strength adaptations in men. Young men will be examined in this initial proof-of-concept study since they are the primary consumers of muscle-building and performance-enhancement supplements and to reduce variation from sex differences in this initial pilot study.
Who can participate?
Young healthy volunteer men aged 18 to 40 years
What does the study involve?
Participants will be allocated 6’-SL supplementation (900 mg/d for 12 weeks) during resistance training and the affects exercise performance, body composition, and strength adaptations will be investigated.
What are the possible benefits and risks of participating?
Benefits and risks not provided at the time of registration
Where is the study run from?
Texas A&M University (TAMU), USA.
When is the study starting and how long is it expected to run for?
April 2025 to December 2025
Who is funding the study?
GeneChem Inc, South Korea.
Who is the main contact?
Dr Richard Kreider, rbkreider@tamu.edu
Contact information
Principal investigator, Scientific
Texas A&M University (TAMU)
675 John Kimbrough Blvd.
#118
College Station
77843-4253
United States of America
 ORCID ID |
0000-0002-3906-1658 |
|---|---|
| Phone | +1 9794581498 |
| rbkreider@tamu.edu |
Public
Texas A&M University (TAMU)
675 John Kimbrough Blvd.
Suite #206
College Station
77843-4253
United States of America
| ORCID ID |
0009-0005-8941-3067 |
|---|---|
| Phone | +1 9794581741 |
| crasmussen@tamu.edu |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | Health services research | |
| Scientific title | Efficacy of human milk oligosaccharide 6'-sialyllactose supplementation on exercise performance and training adaptations | |
| Study acronym | GeneChem Study | |
| Study objectives | The goal of this study is to determine whether dietary supplementation of 6'-SL supplement (900 mg/day for 12 weeks) enhances the benefits of participation in a resistance-training program. | |
| Ethics approval(s) |
Approved 06/01/2025, Texas A&M University (TAMU) Institutional Review Board (IRB) (301 Old Main Drive, Suite #3104, College Station, 77843, United States of America; 979-845-8585; irb@tamu.edu), ref: STUDY2024-1110 | |
| Health condition(s) or problem(s) studied | Dietary supplementation of 6'-SL supplement (900 mg/day for 12 weeks) to enhance the benefits of participation in a resistance-training program. | |
| Intervention | All participants will participate in an exercise training program (two upper body and two lower body workouts per week, consisting of a five-minute warm-up, light stretching, and a periodized resistance training program designed to improve strength and muscle mass that includes all body parts). Additionally, participants will participate in an interval conditioning program designed to increase anaerobic threshold (slow walk for two minutes followed by one-minute intervals at a workload exceeding 80% of Heart Rate Reserve (HRR), repeated five times with heart rate and workloads monitored). Participants will be randomly allocated using block randomisation to the supplements. All participants will be instructed to ingest one of the following supplements every day with breakfast, lunch and dinner for 12 weeks: Treatment 1: Placebo (3 x 300 mg of maltodextrin) Treatment 2: 6'-SL (3 x 300 mg) | |
| Intervention type | Supplement | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 01/12/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Male |
| Target sample size at registration | 24 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. Has given voluntary, written, informed consent to participate in the study 2. Healthy males between the ages of 18 - 40 years 3. Body Mass Index (BMI) less that 40 kg/m2 and/or body fat < 35% 4. Recreationally active individuals capable of performing a whole-body resistance-training and moderate-intensity aerobic exercise program 5. Willing to maintain consistent sleep duration the evening before the study visits |
| Key exclusion criteria | 1. Plan major changes in lifestyle (i.e., diet, dieting, exercise levels, travel) during the study 2. Have a recent history (< 3 months) of exercise training or weight loss (>5%) 3. Have an orthopedic limitation that would prevent participation in a general fitness program 4) Have uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder 5. Have taken muscle-building supplements (e.g., creatine, protein) during the last four weeks or medications that may affect muscle mass or exercise training adaptations 6. Have a known allergy to milk protein 7. Inability to commit to perform and complete the 12-week training program |
| Date of first enrolment | 01/04/2025 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
22/01/2026: Study’s existence confirmed by the Texas A&M University (TAMU) Institutional Review Board (IRB), USA.
