Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time

NCT ID: NCT01540669

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Polydextrose, low dose

Polydextrose, low dose

Group Type: ACTIVE_COMPARATOR

Polydextrose, low dose

Intervention Type: DIETARY_SUPPLEMENT

4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Polydextrose, medium dose

Polydextrose, medium dose

Group Type: ACTIVE_COMPARATOR

Polydextrose, medium dose

Intervention Type: DIETARY_SUPPLEMENT

8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Polydextrose, high dose

Polydextrose, high dose

Group Type: ACTIVE_COMPARATOR

Polydextrose, high dose

Intervention Type: DIETARY_SUPPLEMENT

12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Placebo powder

Placebo powder

Group Type: PLACEBO_COMPARATOR

Placebo powder

Intervention Type: DIETARY_SUPPLEMENT

Placebo powder will be mixed with beverage and consumed once per day for 2 weeks

Interventions

Polydextrose, low dose

4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Intervention Type: DIETARY_SUPPLEMENT

Polydextrose, medium dose

8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Intervention Type: DIETARY_SUPPLEMENT

Polydextrose, high dose

12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo powder

Placebo powder will be mixed with beverage and consumed once per day for 2 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 70 years
• Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
• Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):

Must meet 2 or more of the following criteria:

• Straining during at least 25% of defecations
• Lumpy or hard stools in at least 25% of defecations
• Sensation of incomplete evacuation for at least 25% of defecations
• Sensation of anorectal obstruction/blockage for at least 25% of defecations
• Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
• Fewer than three defecations per week

• Loose stools are rarely present without the use of laxatives
• Insufficient criteria for irritable bowel syndrome
• Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
• Consent to the study and willing to comply with study product and methods
• Willingness to maintain a stable diet throughout the study
• Consistent use and dose of chronic medication, if any, in the past 30 days

Exclusion Criteria

• Major gastrointestinal complication (e.g. Crohn"s disease, colitis, celiac disease)
• Febrile diverticulitis within 1 year of screening
• Pelvic floor dysfunction
• Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results
• Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, removal of gall bladder
• Clinically significant underlying systemic illness that may preclude the subject"s ability to complete the trial or that may confound the study outcomes
• Any clinically relevant abnormalities in the physical examination or in laboratory variables before entry into the study
• Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening
• Laxative, fiber supplement, or other constipation medication (e.g. prokinetic drugs) use within 2 weeks of screening
• Antibiotic use within 1 month of enrollment
• Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#- antagonists, antacids with magnesium or aluminum, or diarrhea medication)
• Anticipated major dietary or exercise changes during the study period
• Known allergies to any substance in the study product
• Pregnant or lactating female, or pregnancy planned during study period
• Eating disorder
• History of alcohol, drug, or medication abuse
• Participation in another study with any investigational product within 3 months of screening
• Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sprim Advanced Life Sciences

OTHER

Sponsor Role: collaborator

Danisco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvio Danese, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinico Humanitas

Milan, , Italy

Countries

Italy

Other Identifiers

Q-PRE-0111-CLI-007

Identifier Type: -

Identifier Source: org_study_id