None listed
Conditions
Brief summary
The gastrointestinal tract is host to a vast number of bacterial species outnumbering the cells of the organism by around 100 fold. The importance of the gut flora (or microbiota) is increasingly being recognised. There is now compelling evidence that the composition of the microbiota in the human gastrointestinal tract (the microbiome) plays an integral role in human health and disease and that altering its composition can have a profound impact on an individual’s metabolic and immune profile. The first few weeks and months of life are known to be critical for the establishment of the gut microbiome, however there is currently limited knowledge of the factors which regulate this development. The omega-3 LCPUFA, DHA, has been shown to promote the colonisation of the gut by beneficial bacteria, and promote gut development, in adult humans, older infants and in animal studies. While breast milk contains some DHA, the amount it contains is directly related to the amount consumed by the mother, and most breastfeeding women in Australia have a low dietary DHA intakes. Therefore, this study aims to determine whether increasing the amount of DHA in breast milk, by providing DHA supplements to breastfeeding women, will promote the colonisation of the infant gut with beneficial bacterial species over the first 3 months of life. The results have the potential to identify a safe and effective approach for promoting the establishment of the healthiest possible gut microbiome in breast-fed infants, something which is known to have both short- and long-term health benefits.
Interventions
Intervention capsule (High omega-3 oil blend)
500mg capsule - 75mg of Eicosapentaenoic acid (EPA) and 250mg of docosahexaenoic acid (DHA) in the form of triglyceride
- each participant will be randomly assigned to either the control or intervention group
- participants will be asked to consume 4 oral capsules (500mg per capsule, 2000mg total/day) per day from randomisation to 12 weeks post-partum
Women will be asked to return unused supplements at 12 weeks post-partum when a spot blood sample is
Intervention capsule (High omega-3 oil blend) 500mg capsule - 75mg of Eicosapentaenoic acid (EPA) and 250mg of docosahexaenoic acid (DHA) in the form of triglyceride - each participant will be randomly assigned to either the control or intervention group - participants will be asked to consume 4 oral capsules (500mg per capsule, 2000mg total/day) per day from randomisation to 12 weeks post-partum Women will be asked to return unused supplements at 12 weeks post-partum when a spot blood sample is taken. The proportion of capsules returned will serve as a measure of adherence. DHA concentration at the end of intervention will be used as an independent biomarker of adherence.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Singleton pregnancy - Intending to exclusively breastfeed for at least 12 weeks post-partum - Willing to take capsules containing fish-oil - Willing to attend a follow-up appointment at Flinders Medical Centre at 12 weeks post-partum (end of the intervention)
Exclusion criteria
- Known major fetal abnormalities - Infants birth weight less than 2500 grams - Caesarean section delivery - Pre-term delivery (less than 37 completed weeks gestation) - Taking high dose fish-oil supplements (providing equal to or more than 250mg DHA/day) - Taking fish-oil supplements (providing less than 250mg DHA/day) and not willing to stop - Bleeding disorder in which fish-oil is contraindicated - Participation in other RCTs involving omega-3 LCPUFA supplementation during pregnancy
Outcome results
None listed