NCT04100460

Brief Summary

The objective of this study is to investigate the effect on Arabinoxylan on gastrointestinal (GI) tolerance, bowel habits, and microbiota in adults. The study is a randomized, placebo-controlled, crossover, single-center trial with 3 study periods separated by minimum 2-week washout periods. 45 healthy adults will be recruited for the trial. Participants will be required to drink a beverage twice a day for 3 weeks during each study period. The beverage will contain either approximately 7.25 grams of Arabinoxylan leaf fiber extract per day, or approximately 14.5 grams of Arabinoxylan leaf fiber extract per day, or will not contain any Arabinoxylan (control). Subjects will record their bowel movements daily, fill out daily questionnaires about their gastrointestinal systems, and record their food intake at specified times during the study. Stool samples will also be collected prior to and at the end of each study period for analysis of bacteria composition.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

September 12, 2019

Last Update Submit

September 20, 2019

Conditions

Gastrointestinal Tolerance

Keywords

Fecal MicrobiotaGastrointestinal toleranceBowel habits

Outcome Measures

Primary Outcomes (2)

  • GI Symptoms Score

    Composite GI symptoms Scores obtained from the Daily GI Tolerance Questionnaire will be obtained by summing the ratings to the 8 individual scores (see below in Outcome 2).

    3 weeks +/- 3 days

  • Individual GI symptoms ratings

    Ratings for each of the 8 individual GI symptoms Scores \[gas/flatulence, nausea, vomiting, abdominal cramping, abdominal distention/bloating, borborygmus/stomach rumbling, burping, and/or reflux (heartburn)\] will be ranked on a 4-point scale (none, mild, moderate, severe) for symptoms experienced over the previous 24 hours.

    3 weeks +/- 3 days

Secondary Outcomes (2)

  • Bowel Habits Dairy

    3 weeks +/- 3 days

  • Fecal Microbiome

    3 weeks +/- 3 days

Study Arms (3)

7.25 grams of Arabinoxylan leaf fiber extract

EXPERIMENTAL

Participants are given 7.25 grams of Arabinoxylan daily

Dietary Supplement: 7.25 grams of Arabinoxylan leaf fiber extract

14.5 grams of Arabinoxylan leaf fiber extract

EXPERIMENTAL

Participants are given 14.5 grams of Arabinoxylan daily

Dietary Supplement: 14.5 grams of Arabinoxylan leaf fiber extract

Control - No Arabinoxylan (Maltodextrin)

PLACEBO COMPARATOR

Participants are given no Arabinoxylan

Dietary Supplement: Control - No Arabinoxylan

Interventions

7.25 grams of Arabinoxylan leaf fiber extractDIETARY_SUPPLEMENT

Participants are given 7.25 grams of Arabinoxylan daily

7.25 grams of Arabinoxylan leaf fiber extract
14.5 grams of Arabinoxylan leaf fiber extractDIETARY_SUPPLEMENT

Participants are given 14.5 grams of Arabinoxylan daily

14.5 grams of Arabinoxylan leaf fiber extract
Control - No ArabinoxylanDIETARY_SUPPLEMENT

Participants are given no Arabinoxylan

Control - No Arabinoxylan (Maltodextrin)

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 18.5 to 35.0 kg/m2 at Visit 1
  • Non- smokers/former users (cessation less than or equal to 12 months)
  • Regular bowel movements; not constipated
  • Willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial
  • Willing to limit alcohol consumption to less than or equal to 2 drinks per day
  • Willing to avoid vigorous physical activity for 24 hrs prior to and during visits
  • Willing to comply with the visit schedule and fecal sample collection/processing/storage requirements
  • No health conditions that would prevent him/her from fulfilling the study requirements based on medical history and routine laboratory test results.
  • Understands the study procedures and signs forms providing consent and authorization of release of relevant protected health information to investigator

You may not qualify if:

  • Abnormal laboratory test results of clinical significance at Visit 1
  • Clinically important GI condition that would potentially interfere with the evaluation of the study product
  • Recent (within 2 weeks of Visit 1) history of an episode of acute GI illness
  • Self reported history (within 6 weeks of visit 1) of constipation
  • Uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric or biliary disorders
  • Uncontrolled hypertension
  • Known allergy, intolerances or sensitivity to any of the ingredients in the study product
  • Extreme dietary habits
  • History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
  • Major trauma or any other surgical event within 3 months of Visit 1
  • Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1
  • Weight loss or gain of greater than 4.5 kg in the 3 months prior to Visit 1
  • Currently or planning to be on a weight loss regimen during the duration of the study
  • Antibiotic use within 3 months of Visit 1
  • Use of steroids within 1 month of Visit 1
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available.

    PMID: 12449285BACKGROUND

Related Links

Study Officials

  • Kathleen Kelley, MD

    Biofortis, Merieux NutriSciences

    PRINCIPAL INVESTIGATOR

  • Rich Troyer

    Comet Bio Inc.

    STUDY DIRECTOR

Central Study Contacts

Kristen Sanoshy

CONTACT

630-330-0463kristen.sanoshy@mxns.com

Christy Cangelosi

CONTACT

847-721-6207ccangelosi@comet-bio.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Study personnel will remain blinded to the sequence assigned to subjects throughout the study. A set of sealed unblinding envelopes will be provided to the Clinical Investigator for use in an emergency situation where a subject's health is at risk.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The study is a randomized, placebo-controlled, crossover, singe-center trial with one screening visit and 3 test periods separated by minimum 2 - week washout periods.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

September 24, 2019

Study Start

September 1, 2019

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share