The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.
Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
Istituto Clinico Humanitas
Milan, Italy
Whole gut transit time
Time frame: 2 weeks
Patient assessment of constipation quality of life
Time frame: 2 weeks
Patient assessment of constipation symptoms
Time frame: 2 weeks
Bowel Function Index
Time frame: 2 weeks
Adequate relief of constipation
Time frame: 2 weeks
Bowel movement frequency
Time frame: 2 weeks
Stool consistency
Time frame: 2 weeks
Degree of straining
Time frame: 2 weeks
Subjective assessment of bowel emptying
Time frame: 2 weeks
Abdominal discomfort/bloating
Time frame: 2 weeks
Overall product satisfaction
Time frame: 2 weeks
Blood and urine safety analysis
Time frame: 2 weeks
Adverse events
Time frame: 2 weeks
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Placebo powder will be mixed with beverage and consumed once per day for 2 weeks