NCT01802112

Brief Summary

The purpose of this study is to assess the efficacy of resistant maltodextrins, compared to placebo, in reducing the colonic transit time in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

28 days

First QC Date

February 22, 2013

Last Update Submit

April 17, 2018

Conditions

Constipation

Keywords

Colonic transitDietary FiberRadiopaque marker

Outcome Measures

Primary Outcomes (1)

  • Changes in Colonic Transit Time (CTT)

    to determine CTT volunteers should ingest a capsule of radiopaque markers each day for five consecutive days. 24 hours after the final intake of markers an abdominal X-ray should be performed.

    28 days from the start of the study

Secondary Outcomes (8)

  • Segmental colonic transit time (SCTT)

    28 days from the start of the study

  • Defecation frequency (DF)

    28 days

  • Stool Consistency

    28 days

  • Stool volume by just their eye observation

    28 days

  • Clinical Variables of Intestinal Function

    28 days

  • +3 more secondary outcomes

Other Outcomes (1)

  • Adverse Events

    29 days

Study Arms (2)

Maltodextrins

PLACEBO COMPARATOR

15 grams of maltodextrins per day dissolved in water during 21 days

Other: placebo

Resistant maltodextrins

EXPERIMENTAL

15 grams of resistant maltodextrins per day, dissolved in water during 21 days

Dietary Supplement: Resistant maltodextrins

Interventions

Resistant maltodextrinsDIETARY_SUPPLEMENT

15 grams of Resistant maltodextrins per day dissolved in water during 21 days

Also known as: Fibersol®
Resistant maltodextrins
placeboOTHER

15gr placebo

Maltodextrins

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects of both sexes (men and women) between 18 and 30 years old of Caucasian race selected from the general population
  • Subjects capable of understanding the clinical study, willing to provide written informed consent and to fulfil the procedures and requirements of the study.

You may not qualify if:

  • Diagnosis of a BMI ≥ 30 Kg/m2.
  • Individuals with a daily defecation habit.
  • Subjects with a history of any digestive disease or who have undergone gastrointestinal surgery (excluding appendicectomy or herniorrhaphy), abdominal surgery in the last two years or any recent major extra-abdominal surgery.
  • Subjects with diabetes, hypothyroidism or hyperthyroidism.
  • Subjects with a history of systemic disease that might effect gut motility.
  • Subjects on dietary treatment and/or drugs that effect body weight or appetite.
  • Individuals that have had any change in dietary habit in the last 2 months.
  • Subjects with a history of drug or alcohol abuse, or other substances or factors that might limit their ability to cooperate during the study.
  • Subjects with bowel habits affected by stress.
  • Subjects taking medication or drugs that alter gut motility.
  • Pregnant women.
  • Subjects that have stopped smoking in the last 6 months or who intend to give up smoking during the study.
  • Subjects with allergies or eating disorders.
  • Subjects that consume an excessive amount of alcohol (\>3 glasses of wine or beer per day)
  • Individuals that engage in physical exercise two or more times per week.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Antonio Catholic University of Murcia

Guadalupe, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2013

First Posted

March 1, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

April 19, 2018

Record last verified: 2018-04

Locations

ES(1)