ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01862341
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : August 7, 2013
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Fonterra Research Centre

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

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: ANMUM In-Shape Nutritional Milk Powder for Active Mothers Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Bowel improvement [ Time Frame: up to day 28 ]
    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 :
  1. Intestinal health [ Time Frame: Day 0 and day 28 ]
    Assess intestinal improvement determined by questionnaire on sensation after bowel movement and state of stools (color, odor, shape) through a questionnaire.

  2. General well-being and lifestyle attitudes [ Time Frame: Day 3, 7, 10, 14, 21, 24, and 28 ]
    Assess the general well-being and lifestyle attitudes through a questionnaire.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fonterra Research Centre
ClinicalTrials.gov Identifier: NCT01862341     History of Changes
Other Study ID Numbers: FON-JOLIE-PPH-2012-01
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

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

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