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

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

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: ANMUM In-Shape Nutritional Milk Powder for Active Mothers

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Makati, Philippines
    • Villamor Air Base
  • Manilla, Philippines
    • Camp Aguinaldo
  • Quezon, Philippines
    • Camp Crame
  • Taguig, Philippines
    • Camp Bagong Diwa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Milk powder; 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.	Dietary supplement: ANMUM In-Shape Nutritional Milk Powder for Active Mothers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal health	Assess intestinal improvement determined by questionnaire on sensation after bowel movement and state of stools (color, odor, shape) through a questionnaire.	Day 0 and day 28
General well-being and lifestyle attitudes	Assess the general well-being and lifestyle attitudes through a questionnaire.	Day 3, 7, 10, 14, 21, 24, and 28

Collaborators and Investigators

• Sponsor: Fonterra Research Centre
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: Imelda Agdeppa, PhD, FNRI

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: May 10, 2013
• First Submitted That Met QC Criteria: May 23, 2013
• First Posted (Estimate): May 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Constipation; Intestinal health; Bowel movement
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: FON-JOLIE-PPH-2012-01