NCT04495972

Brief Summary

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration 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

First Submitted

Initial submission to the registry

July 27, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

July 27, 2020

Last Update Submit

November 10, 2023

Conditions

PreDiabetes

Keywords

Prediabetic StateMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    as measured by Homeostatic Model Assessment (HOMA) - index

    12 weeks

Secondary Outcomes (2)

  • Concentration of Fasting glucose

    12 weeks

  • Level of 2-hour blood glucose Area Under the Curve (AUC)

    12 weeks

Study Arms (2)

Experimental arm: Intestinimonas

ACTIVE COMPARATOR

Intestinimonas in capsules

Dietary Supplement: Intestinimonas-capsules

Placebo arm: Placebo

PLACEBO COMPARATOR

Placebo in capsules

Dietary Supplement: Placebo-capsules

Interventions

Intestinimonas-capsulesDIETARY_SUPPLEMENT

Capsules containing microbiota (Intestinimonas)

Experimental arm: Intestinimonas
Placebo-capsulesDIETARY_SUPPLEMENT

Placebo capsules are identical to the active treatment

Placebo arm: Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • increased BMI \> 25,
  • Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose \> 140 after OGTT, or HbA1c 5.7% - 6.4%

You may not qualify if:

  • Type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Piemonte Orientale

Vercelli, Italy

Location

MeSH Terms

Conditions

Prediabetic StateMetabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Double-blind, randomized, placebo-controlled study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 3, 2020

Study Start

January 15, 2021

Primary Completion

September 12, 2023

Study Completion

November 10, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

IT(1)