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

NCT ID: NCT01862341

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-07-31

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

Conditions

Constipation

Keywords

Constipation; Bowel movement; Intestinal health

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ANMUM In-Shape Nutritional Milk Powder for Active Mothers

Intervention Type: DIETARY_SUPPLEMENT

Interventions

ANMUM In-Shape Nutritional Milk Powder for Active Mothers

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sprim Advanced Life Sciences

OTHER

Sponsor Role: collaborator

Fonterra Research Centre

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imelda Agdeppa, PhD

Role: PRINCIPAL_INVESTIGATOR

FNRI

Locations

Camp Bagong Diwa

City of Taguig, , Philippines

Villamor Air Base

Makati, , Philippines

Camp Aguinaldo

Manila, , Philippines

Camp Crame

Quezon, , Philippines

Countries

Philippines

Other Identifiers

FON-JOLIE-PPH-2012-01

Identifier Type: -

Identifier Source: org_study_id