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Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects

NCT05391854 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-06-28

No results posted yet for this study

Summary

The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.

Conditions

  • Prediabetic State

Interventions

DIETARY_SUPPLEMENT

Pep2dia

700 mg Pep2Dia® 15 min prior to breakfast and 700 mg Pep2Dia® 15 min prior to dinner

DIETARY_SUPPLEMENT

Placebo

700 mg placebo 15 min prior to breakfast and 700 mg placebo 15 min prior to dinner

Sponsors & Collaborators

  • BioTeSys GmbH

    collaborator OTHER

  • Ingredia S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-05-05
Completion
2023-06-20

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391854 on ClinicalTrials.gov