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The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
ANMUM In-Shape Nutritional Milk Powder for Active Mothers
Sponsored by
Fonterra Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, Bowel movement, Intestinal health

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female between 21 and 35 years of age.
  • Has at least one child under the age of three.
  • Willingness and ability to participate in the study.
  • Suffering from mild to moderate constipation and bowel troubles, and non-specific symptoms including bloating, flatulence, gurgling, feeling heavy after eating, and abdominal pain.
  • Slow transit or irregular bowels movements (stool consistency harder than usual or fewer bowel movements, i.e. every 2-3 days or less than 3 bowel movements per week).
  • Agree to maintain dietetic measures (on their own volition or as previously recommended by health/nutrition professionals), if any, during the study period.
  • Subject, or subject's legally acceptable representative, has voluntarily signed and dated an informed consent form, approved by a local Ethics Committee/Institutional Review Board authorization prior to any participation in the study.

Exclusion Criteria:

  • Having participated in another trial currently and up to two months prior to this trial date.
  • Known chronic constipation.
  • Treated gastrointestinal symptoms.
  • Regular intake of laxatives or other remedies to promote digestion (herbal teas, peppermint etc.) during the two weeks before the start of the study or during the study.
  • Consuming dairy products or supplements containing Probiotics (e.g., yogurt, Lactic acid drink, drinkable yogurt, food supplements, extracts), Prebiotics (e.g., Oligosaccharides), or fiber supplements within 10 days prior to the start of the study or during the study.
  • Currently taking (and during the past 3 months) any dietary fiber supplementation except from food sources.
  • Previous contraindication to fiber supplement (Crohn's disease).
  • Recently or currently on antibiotic medication in the past two weeks.
  • Known allergy to milk proteins or intolerance to lactose.
  • Currently pregnant.

Sites / Locations

  • Villamor Air Base
  • Camp Aguinaldo
  • Camp Crame
  • Camp Bagong Diwa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Milk powder

Arm Description

ANMUM In-Shape Nutritional Milk Powder for Active Mothers. The dose of the milk powder is 40g added to 200ml of drinkable water and will be taken twice a day.

Outcomes

Primary Outcome Measures

Bowel improvement
Evaluate the perceptions of selected Filipino women (21-35 years of age) on the effectiveness of milk powder with fiber and probiotics on improving bowel movement through questionnaires.

Secondary Outcome Measures

Intestinal health
Assess intestinal improvement determined by questionnaire on sensation after bowel movement and state of stools (color, odor, shape) through a questionnaire.
General well-being and lifestyle attitudes
Assess the general well-being and lifestyle attitudes through a questionnaire.

Full Information

First Posted
May 10, 2013
Last Updated
August 6, 2013
Sponsor
Fonterra Research Centre
Collaborators
Sprim Advanced Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01862341
Brief Title
The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
Official Title
The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fonterra Research Centre
Collaborators
Sprim Advanced Life Sciences

4. Oversight

5. Study Description

Brief Summary
In-Shape Nutritional Milk Powder is a nutritional milk powder containing fibers, probiotics and other nutrients. This study will focus on the effects of fiber and probiotics on digestive health and health well being in selected Filipino mothers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation, Bowel movement, Intestinal health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milk powder
Arm Type
Experimental
Arm Description
ANMUM In-Shape Nutritional Milk Powder for Active Mothers. The dose of the milk powder is 40g added to 200ml of drinkable water and will be taken twice a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
ANMUM In-Shape Nutritional Milk Powder for Active Mothers
Primary Outcome Measure Information:
Title
Bowel improvement
Description
Evaluate the perceptions of selected Filipino women (21-35 years of age) on the effectiveness of milk powder with fiber and probiotics on improving bowel movement through questionnaires.
Time Frame
up to day 28
Secondary Outcome Measure Information:
Title
Intestinal health
Description
Assess intestinal improvement determined by questionnaire on sensation after bowel movement and state of stools (color, odor, shape) through a questionnaire.
Time Frame
Day 0 and day 28
Title
General well-being and lifestyle attitudes
Description
Assess the general well-being and lifestyle attitudes through a questionnaire.
Time Frame
Day 3, 7, 10, 14, 21, 24, and 28

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female between 21 and 35 years of age. Has at least one child under the age of three. Willingness and ability to participate in the study. Suffering from mild to moderate constipation and bowel troubles, and non-specific symptoms including bloating, flatulence, gurgling, feeling heavy after eating, and abdominal pain. Slow transit or irregular bowels movements (stool consistency harder than usual or fewer bowel movements, i.e. every 2-3 days or less than 3 bowel movements per week). Agree to maintain dietetic measures (on their own volition or as previously recommended by health/nutrition professionals), if any, during the study period. Subject, or subject's legally acceptable representative, has voluntarily signed and dated an informed consent form, approved by a local Ethics Committee/Institutional Review Board authorization prior to any participation in the study. Exclusion Criteria: Having participated in another trial currently and up to two months prior to this trial date. Known chronic constipation. Treated gastrointestinal symptoms. Regular intake of laxatives or other remedies to promote digestion (herbal teas, peppermint etc.) during the two weeks before the start of the study or during the study. Consuming dairy products or supplements containing Probiotics (e.g., yogurt, Lactic acid drink, drinkable yogurt, food supplements, extracts), Prebiotics (e.g., Oligosaccharides), or fiber supplements within 10 days prior to the start of the study or during the study. Currently taking (and during the past 3 months) any dietary fiber supplementation except from food sources. Previous contraindication to fiber supplement (Crohn's disease). Recently or currently on antibiotic medication in the past two weeks. Known allergy to milk proteins or intolerance to lactose. Currently pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imelda Agdeppa, PhD
Organizational Affiliation
FNRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Villamor Air Base
City
Makati
Country
Philippines
Facility Name
Camp Aguinaldo
City
Manilla
Country
Philippines
Facility Name
Camp Crame
City
Quezon
Country
Philippines
Facility Name
Camp Bagong Diwa
City
Taguig
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.

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