Non-alcoholic Malt Product in LactationNCT02523729
Effects of Anke Malz on Women During Lactation
A study testing Anke Malz in people with Non-alcoholic Malt Product in Lactation, run by China Medical University Hospital.
Trial summary
Human milk is the most optimal food to provide all infants' needs before eating solid food. However, underproduction of milk is a common and concerned problem for breastfeeding women. In this case, proper milk-making foods reveal their importance on lactation. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Malt Product in Lactation
- What is being tested?
- Anke Malz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single fetal pregnancy
- Full time birth
Who cannot join
- Any complication during pregnancy
- Smokers
- Alcohol or drug abuse
About this study
Human milk is the most optimal food to provide all infants' needs before eating solid food. However, underproduction of milk is a common and concerned problem for breastfeeding women. In this case, proper milk-making foods reveal their importance on lactation. In many European countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate the secretion of breast milk. This study estimates the effects of non-alcoholic malt product during first three months of lactation.
- Conditions
- Non-alcoholic Malt Product in Lactation
- Being tested
- Anke Malz
- Keywords
- lactation, human milk, maltz, antioxidant
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anke MalzDietary supplement
non-alcoholic malt drink
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | subjects drunk no Anke Malz product. |
| intervention one | Experimental | subjects drunk one can Anke Malz product. Receives: Dietary Supplement: Anke Malz |
| intervention two | Experimental | subjects drunk two cans Anke Malz product. Receives: Dietary Supplement: Anke Malz |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of prolactin on lactational women
Measured: three months
Secondary outcomes (1)
Mean breast-feeding time
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJul 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Malt Product in LactationStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lorillard Tobacco Company
- Responsible party
- Principal investigator, Hui-Ting Yang, China Medical University Hospital
- Investigators
- Hui-Ting Yang, Doctor, Study chair, Department of Nutrition, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523729
- Sponsor's protocol ID
- CMUH102-REC3-053
- Status last verified
- Aug 2015
- First submitted
- 3 Mar 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grossman ER. Beer, breast-feeding, and the wisdom of old wives. JAMA. 1988 Feb 19;259(7):1016. No abstract available.
PubMed 3339797Foo LL, Quek SJ, Ng SA, Lim MT, Deurenberg-Yap M. Breastfeeding prevalence and practices among Singaporean Chinese, Malay and Indian mothers. Health Promot Int. 2005 Sep;20(3):229-37. doi: 10.1093/heapro/dai002. Epub 2005 Apr 6.
PubMed 15814526Carlson HE, Wasser HL, Reidelberger RD. Beer-induced prolactin secretion: a clinical and laboratory study of the role of salsolinol. J Clin Endocrinol Metab. 1985 Apr;60(4):673-7. doi: 10.1210/jcem-60-4-673.
PubMed 3972968Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
PubMed 23178060Adiong JP, Kim E, Koren G, Bozzo P. Consuming non-alcoholic beer and other beverages during pregnancy and breastfeeding. Can Fam Physician. 2014 Aug;60(8):724-5.
PubMed 25122816
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anke Malz on Women During Lactation
- ClinicalTrials.gov ID
- NCT02523729
- Acronym / sponsor ID
- CMUH102-REC3-053
- Conditions
- Non-alcoholic Malt Product in Lactation
- Keywords
- lactation, human milk, maltz, antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Lorillard Tobacco Company
- Study start
- Jul 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human milk is the most optimal food to provide all infants' needs before eating solid food. However, underproduction of milk is a common and concerned problem for breastfeeding women. In this case, proper milk-making foods reveal their importance on lactation. In many European countries, ancient wisdom clams that non-alcoholic malt beverage could facilitate the secretion of breast milk. This study estimates the effects of non-alcoholic malt product during first three months of lactation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –subjects drunk no Anke Malz product. |
| intervention one | Experimental | Dietary Supplement: Anke Malzsubjects drunk one can Anke Malz product. |
| intervention two | Experimental | Dietary Supplement: Anke Malzsubjects drunk two cans Anke Malz product. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single fetal pregnancy
- Full time birth
Key exclusion criteria (3 listed)
- Any complication during pregnancy
- Smokers
- Alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anke Malznon-alcoholic malt drink | Dietary supplement | intervention one, intervention two |
Primary outcome
The concentration of prolactin on lactational women
Time frame: three months
1 secondary outcome
Mean breast-feeding time
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Background: PubMed 3339797Grossman ER. Beer, breast-feeding, and the wisdom of old wives. JAMA. 1988 Feb 19;259(7):1016. No abstract available.
- Results publication: PubMed 15814526Foo LL, Quek SJ, Ng SA, Lim MT, Deurenberg-Yap M. Breastfeeding prevalence and practices among Singaporean Chinese, Malay and Indian mothers. Health Promot Int. 2005 Sep;20(3):229-37. doi: 10.1093/heapro/dai002. Epub 2005 Apr 6.
- Results publication: PubMed 3972968Carlson HE, Wasser HL, Reidelberger RD. Beer-induced prolactin secretion: a clinical and laboratory study of the role of salsolinol. J Clin Endocrinol Metab. 1985 Apr;60(4):673-7. doi: 10.1210/jcem-60-4-673.
- Results publication: PubMed 23178060Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
- Results publication: PubMed 25122816Adiong JP, Kim E, Koren G, Bozzo P. Consuming non-alcoholic beer and other beverages during pregnancy and breastfeeding. Can Fam Physician. 2014 Aug;60(8):724-5.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Ting Yang, Doctor study chair
Department of Nutrition, China Medical University, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing Anke Malz in people with Non-alcoholic Malt Product in Lactation, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of prolactin on lactational women (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02523729, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2015.