NCT Number: NCT01862341
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
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Notify MeKey information
Conditions
Age range
21 year–35 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Camp Bagong Diwa, City of Taguig, Philippines
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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.
-
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.
Sponsors and collaborators
Lead sponsor
Fonterra Research Centre
Industry
Collaborators
- Sprim Advanced Life Sciences
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- May 24, 2013
- Registry last updated
- Aug 7, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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