Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

NCT02314936 | Completed Phase 2 Results

• 1 other identifier: 01-2014
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.

Conditions

Functional Constipation

Keywords

Constipation; Polydextrose; Dietary Fiber; PAC-QoL; Colonic Transit Time; PAC-SYM

Outcome Measures

Primary Outcomes (1)

• Change in Colonic Transit Time From Baseline to Day 15

  Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.

  Baseline and Day 15

Secondary Outcomes (11)

• Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15

  Baseline and Day 15

• Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15

  Baseline and Day 15

• Change in Bowel Function Index From Baseline to Day 15

  Baseline and Day 15

• Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15

  Baseline and Day 15

• Change in Stool Frequency From Baseline to Day 15

  14 day run-in and Week 2 of the 14-day supplementation period

Other Outcomes (33)

• Change in Hemoglobin Levels From Baseline to Day 15

  Screening and Day 15 (end of study)

• Change in Hematocrit Levels From Screening to Day 15

  Screening and Day 15 (end of study)

• Change in White Blood Cell Count From Baseline to Day 15

  Screening and Day 15 (end of study)

Study Arms (4)

Litesse powder containing 12 g polydextrose

EXPERIMENTAL

12 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Dietary Supplement: Litesse powder containing 12 g polydextrose

Litesse powder containing 8 g polydextrose

EXPERIMENTAL

8 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Dietary Supplement: Litesse powder containing 8 g polydextrose

Litesse powder containing 4 g polydextrose

EXPERIMENTAL

4 g of polydextrose, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Dietary Supplement: Litesse powder containing 4 g polydextrose

Placebo

PLACEBO COMPARATOR

Maltodextrin, 1 sachet of powder mixed with water taken daily with breakfast for 2 weeks

Dietary Supplement: Placebo

Interventions

Litesse powder containing 12 g polydextrose DIETARY_SUPPLEMENT

12 g polydextrose

Also known as: Litesse powder

Litesse powder containing 12 g polydextrose

Litesse powder containing 8 g polydextrose DIETARY_SUPPLEMENT

8 g polydextrose, 4 g maltodextrin

Also known as: Litesse powder

Litesse powder containing 8 g polydextrose

Litesse powder containing 4 g polydextrose DIETARY_SUPPLEMENT

4 g polydextrose, 8 g maltodextrin

Also known as: Litesse powder

Litesse powder containing 4 g polydextrose

Placebo DIETARY_SUPPLEMENT

12 g Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years.
• Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight).
• If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation).
• Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Intrauterine devices, Double barrier method, Vasectomy of partner (shown successful as per appropriate follow-up), Tubal ligation, and Non-heterosexual lifestyle (same sex partner).
• 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.
• Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

You may not qualify if:

• Major gastrointestinal complication (e.g. Crohn's disease, colitis, celiac disease)
• Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results.
• Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness).
• Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products.
• Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study).
• Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs), within 1 month before screening.
• Anticipated major dietary or exercise changes during the study.
• Systemic steroid use, within 1 month before screening.
• Eating disorder.
• Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product).
• History of alcohol, drug, or medication abuse.
• Pregnant or lactating female, or pregnancy planned during study period.
• Participation in another study with any investigational product within 60 days of screening.
• Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
• Subject under administrative or legal supervision.

Sponsors & Collaborators

• KGK Science Inc.: lead
• DuPont Nutrition and Health: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Constipation

Interventions

polydextrose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study population was not sufficiently constipated at baseline.

Results Point of Contact

• Title: Dr. Tetyana Pelipyagina
• Organization: KGK Synergize Inc.

drtetyana@kgksynergize.com

5194389374

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 11, 2014
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 9, 2018
• Results First Posted: November 9, 2018

Record last verified: 2018-04

Locations

CA (1)