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

This study has been completed.
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Fonterra Research Centre
ClinicalTrials.gov Identifier:
NCT01862341
First received: May 10, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Constipation
Dietary Supplement: ANMUM In-Shape Nutritional Milk Powder for Active Mothers

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Milk Powder With Fiber and Probiotics on Digestive Habits and General Health Well-being of Selected Filipino Mothers.

Resource links provided by NLM:


Further study details as provided by Fonterra Research Centre:

Primary Outcome Measures:
  • Bowel improvement [ Time Frame: up to day 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0 and day 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 3, 7, 10, 14, 21, 24, and 28 ] [ Designated as safety issue: No ]
    Assess the general well-being and lifestyle attitudes through a questionnaire.


Enrollment: 72
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862341

Locations
Philippines
Villamor Air Base
Makati, Philippines
Camp Aguinaldo
Manilla, Philippines
Camp Crame
Quezon, Philippines
Camp Bagong Diwa
Taguig, Philippines
Sponsors and Collaborators
Fonterra Research Centre
Sprim Advanced Life Sciences
Investigators
Principal Investigator: Imelda Agdeppa, PhD FNRI
  More Information

No publications provided

Responsible Party: Fonterra Research Centre
ClinicalTrials.gov Identifier: NCT01862341     History of Changes
Other Study ID Numbers: FON-JOLIE-PPH-2012-01
Study First Received: May 10, 2013
Last Updated: August 6, 2013
Health Authority: Philippines : Food and Drug Administration

Keywords provided by Fonterra Research Centre:
Constipation
Bowel movement
Intestinal health

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014