Constipation
Conditions
Keywords
Constipation, Bowel movement, Intestinal health
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
Interventions
DIETARY_SUPPLEMENTANMUM In-Shape Nutritional Milk Powder for Active Mothers
Sponsors
Sprim Advanced Life Sciences
Fonterra Research Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel improvement | 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
| Measure | Time frame | Description |
|---|---|---|
| Intestinal health | 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 | Day 3, 7, 10, 14, 21, 24, and 28 | Assess the general well-being and lifestyle attitudes through a questionnaire. |
Countries
Philippines
Outcome results
None listed