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Completed

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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Key information

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Camp Bagong Diwa, City of Taguig, Philippines

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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

ANMUM In-Shape Nutritional Milk Powder for Active Mothers

Dietary Supplement

Primary outcomes

  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 outcomes

  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.

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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