Effects of Anke Malz on Women During Lactation

August 13, 2015 updated by: Hui-Ting Yang, China Medical University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Single fetal pregnancy
  • Full time birth

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
subjects drunk no Anke Malz product.
EXPERIMENTAL: intervention one
subjects drunk one can Anke Malz product.
Dietary supplement: Anke Malz
non-alcoholic malt drink
EXPERIMENTAL: intervention two
subjects drunk two cans Anke Malz product.
Dietary supplement: Anke Malz
non-alcoholic malt drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The concentration of prolactin on lactational women
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean breast-feeding time
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

Lorillard Tobacco Company

Investigators

  • Study Chair: Hui-Ting Yang, Doctor, Department of Nutrition, China Medical University, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (ESTIMATE)

August 14, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMUH102-REC3-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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