NCT01862341

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

May 10, 2013

Last Update Submit

August 6, 2013

Conditions

Constipation

Keywords

ConstipationBowel movementIntestinal health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Intestinal health

    Day 0 and day 28

  • General well-being and lifestyle attitudes

    Day 3, 7, 10, 14, 21, 24, and 28

Study Arms (1)

Milk powder

EXPERIMENTAL

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

Interventions

ANMUM In-Shape Nutritional Milk Powder for Active MothersDIETARY_SUPPLEMENT
Milk powder

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Camp Bagong Diwa

City of Taguig, Philippines

Location

Villamor Air Base

Makati, Philippines

Location

Camp Aguinaldo

Manila, Philippines

Location

Camp Crame

Quezon, Philippines

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Imelda Agdeppa, PhD

    FNRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 24, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

PH(4)