NCT02523729

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

March 3, 2015

Last Update Submit

August 13, 2015

Conditions

Keywords

lactationhuman milkmaltzantioxidant

Outcome Measures

Primary Outcomes (1)

  • The concentration of prolactin on lactational women

    three months

Secondary Outcomes (1)

  • Mean breast-feeding time

    three months

Study Arms (3)

control

NO INTERVENTION

subjects drunk no Anke Malz product.

intervention one

EXPERIMENTAL

subjects drunk one can Anke Malz product.

Dietary Supplement: Anke Malz

intervention two

EXPERIMENTAL

subjects drunk two cans Anke Malz product.

Dietary Supplement: Anke Malz

Interventions

Anke MalzDIETARY_SUPPLEMENT

non-alcoholic malt drink

intervention oneintervention two

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Single fetal pregnancy
  • Full time birth

You may not qualify if:

  • Any complication during pregnancy
  • Smokers
  • Alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Grossman ER. Beer, breast-feeding, and the wisdom of old wives. JAMA. 1988 Feb 19;259(7):1016. No abstract available.

    PMID: 3339797BACKGROUND
  • Foo 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.

  • Carlson 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.

  • Ballard 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.

  • Adiong 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Hui-Ting Yang, Doctor

    Department of Nutrition, China Medical University, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 3, 2015

First Posted

August 14, 2015

Study Start

July 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 14, 2015

Record last verified: 2015-08