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A Clinical Study to Assess the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects

NCT ID: NCT04603378

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2017-11-28

Brief Summary

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This exploratory, randomized, double-blind, placebo-controlled study aims to explore the effect of novel glycans on nitrogen metabolism in the gut in healthy subjects using a stable isotope.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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KB195

Group Type OTHER

KB195

Intervention Type OTHER

KB195 is a novel glycan

Polydextrose

Group Type OTHER

Polydextrose

Intervention Type OTHER

Polydextrose is an oligosaccharide

Pullulan

Group Type OTHER

Pullulan

Intervention Type OTHER

Pullulan is an oligosaccharide

Maltodextrin

Group Type OTHER

Maltodextrin

Intervention Type OTHER

Maltodextrin is a digestible carbohydrate

Interventions

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KB195

KB195 is a novel glycan

Intervention Type OTHER

Polydextrose

Polydextrose is an oligosaccharide

Intervention Type OTHER

Pullulan

Pullulan is an oligosaccharide

Intervention Type OTHER

Maltodextrin

Maltodextrin is a digestible carbohydrate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willing to provide multiple stool samples
* Be male or female, ≥18 and \<50 years of age
* Have a body mass index ≥18 and \<50 kg/m2
* No current renal, hepatic or metabolic disease, significant dyslipidemia, or infection
* Willing to adhere to dietary requirements as stated in the protocol
* Willing to continue usual exercise routine
* Willing to continue taking any current supplements and vitamins (with the exception of prebiotic or probiotic supplements) that the subject is currently taking, for the duration of the study

Patients will be excluded from the study if they meet any of the following criteria at screening :

* Currently taking probiotic or prebiotic dietary supplements, or have taken them in the past 28 days (prior to Screening Visit), or unwilling to avoid prebiotic or probiotic dietary supplements for the duration of the study
* Currently taking, or have taken during the last seven days prior to enrollment, drugs or other compounds that modulate GI motility
* Currently taking bismuth, or have taken bismuth within seven days prior to enrollment
* Recent history (within six weeks of Screening Visit) of the following condition requiring medical attention or treatment, including over-the-counter medications: constipation, diarrhea, and/or acute GI illness.
* Systemic antibiotics taken within the previous three months (prior to Screening Visit).
* History of or active inflammatory bowel disease
* History of or active irritable bowel syndrome
* History of or active autoimmune disease.
* History of or active GI malignancy.
* Established pre-diabetic status (eg, multiple fasting blood glucose measurements 100 to 125 mg/dL inclusive, or history of failed glucose tolerance tests) and as assessed by HbA1c test.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kaleido Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Wingertzahn, PhD

Role: STUDY_DIRECTOR

Kaleido Biosciences

Locations

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PPD Phase I Clinic

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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K010-117

Identifier Type: -

Identifier Source: org_study_id