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Effect of a Plant-based Hydrolysates Daily Consumption on the HbA1c of Pre-diabetic Subjects

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Latvia
Study Type
Interventional
Intervention
12 weeks daily administration Cereal 1
12 weeks daily administration Cereal 2
12 weeks daily administration Placebo
Sponsored by
Onorach Clinical Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provide written informed consent,
  • Be aged between 18 and 75 years, inclusive,
  • Have a HbA1c of > 5.7% and < 6.4% (38.8mmol/mol- 47mmol/mol),
  • Be a non-smoker or an ex-smoker (10 years or more),
  • Have a body mass index (BMI) 20 - 35 kg/m²,
  • Have a stable bodyweight (+/- 5%) in the last 3 months (as self-reported by the subject),
  • Be willing to maintain existing dietary habits and physical activity levels throughout the trial period,
  • Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator.

Exclusion Criteria:

  • Diagnosed diabetes with a HbA1c >6.4% (47mmol/mol)
  • Body Mass Index (BMI) less than 20 (underweight) or greater than 35 (morbidly obese)
  • Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease or any condition which contraindicates, in the investigators judgement, entry to the study
  • Consumption of more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females
  • Currently or recently (within 3 months of study entry) taking any medication, which in the opinion of the investigator, could interfere with the outcome of the study, including insulin, acetylsalicylic acid, thyroxine etc.
  • If subjects are taking hypolipidemic agents and/or beta-blockers
  • Known allergy to any of the components of the test product
  • History of drug or alcohol abuse
  • Present or recent use (within 3 months of pre-screening) of dietary supplements that may affect the level of blood glucose, e.g. chromium, dietary fibres and non-digestible carbohydrates e.g. fructo-oligosaccharides chicory inulin, mulberry leaf extract, e.t.c (Note: There are many dietary supplements, both approved and unapproved, marketed for the regulation of blood glucose. The Principal Investigator will discuss any uncertain cases directly with the study sponsor prior to inclusion of any such subjects)
  • Low hemoglobin or hematocrit (i.e., lower than normal ranges specified and in-use at the local laboratory designated for this study),
  • Females are pregnant, lactating or wish to become pregnant during the study.
  • Participation in a clinical trial with an investigational product within 90 days before pre-screening, or plans to participate in another study during the study period,
  • Subject has a history of non-compliance

Sites / Locations

  • P. Stradins Clinical University Hospital
  • Clinic "Adoria" SIA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

12 weeks daily administration Placebo

12 weeks daily administration Cereal 1

12 weeks daily administration Cereal 2

Arm Description

Intervention: 12 weeks daily administration. The placebo is a powder: microcrystalline cellulose. The daily dose administrated is 15 grams.

Intervention: 12 weeks daily administration. The plant-based hydrolysate is a powder. The product results from an extraction of the protein of a cereal (Cereal 1). The daily dose administrated is 15 grams.

Intervention: 12 weeks daily administration. The plant-based hydrolysate is a powder. The product results from an extraction of the protein of a cereal (Cereal 2). The daily dose administrated is 15 grams.

Outcomes

Primary Outcome Measures

Effect of the treatment on reduction of the HbA1c level (%)
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at reducing the HbA1c level (%).

Secondary Outcome Measures

Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial glucose level
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at reducing the post-prandial glucose level (mmol/L).
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial insulin level
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at modifying the post-prandial insulin level (microU/mL).
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: fructosamine level
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at modifying the fructosamine level (microU/mL).
Effect of the treatment on evolution of the subject weight
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at reducing the weight (kg).

Full Information

First Posted
February 15, 2019
Last Updated
November 1, 2019
Sponsor
Onorach Clinical Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03851666
Brief Title
Effect of a Plant-based Hydrolysates Daily Consumption on the HbA1c of Pre-diabetic Subjects
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Exploratory Study to Assess the Effect of a Once Daily Administration of a Plant-based Hydrolysates in the Reduction of Hb1A) Levels in Pre-diabetic Volunteers.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onorach Clinical Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effect in HbA1c levels of a once daily administration of plant-based hydrolysates in pre-diabetic, but otherwise healthy volunteers. Among the 63 subjects enrolled, 21 will receive a plant-based hydrolysates from one cereal, 21 will receive a plant-based hydrolysates from another cereal and 21 will receive a placebo.
Detailed Description
Pre-clinical data on human skeletal muscle cells and mouse Type 2 diabetes model have shown a blood glucose lowering effect of the plant-based hydrolysates. The first objective of the study is to evaluate the effect of a once daily administration of 2 different cereal protein hydrolysates versus placebo, when consumed over a 12-week period, at reducing the preferred outcome measure identified by the European Food Safety Authority i.e. glycated haemoglobin (HbA1c) levels in pre-diabetic volunteers who are otherwise healthy subjects. The second objective of the study is to evaluate the effect of a fixed daily administration of 2 different cereal protein hydrolysates versus placebo, when consumed over a 12-week period on further supportive measures like Post-prandial glucose/insulin levels, fructosamine level, fasting plasma glucose level, vital signs and blood pressure, weight and BMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 weeks daily administration Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: 12 weeks daily administration. The placebo is a powder: microcrystalline cellulose. The daily dose administrated is 15 grams.
Arm Title
12 weeks daily administration Cereal 1
Arm Type
Experimental
Arm Description
Intervention: 12 weeks daily administration. The plant-based hydrolysate is a powder. The product results from an extraction of the protein of a cereal (Cereal 1). The daily dose administrated is 15 grams.
Arm Title
12 weeks daily administration Cereal 2
Arm Type
Active Comparator
Arm Description
Intervention: 12 weeks daily administration. The plant-based hydrolysate is a powder. The product results from an extraction of the protein of a cereal (Cereal 2). The daily dose administrated is 15 grams.
Intervention Type
Dietary Supplement
Intervention Name(s)
12 weeks daily administration Cereal 1
Intervention Description
The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product. Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation. The daily dose administrated is 15 grams.
Intervention Type
Dietary Supplement
Intervention Name(s)
12 weeks daily administration Cereal 2
Intervention Description
The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product. Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation. The daily dose administrated is 15 grams.
Intervention Type
Other
Intervention Name(s)
12 weeks daily administration Placebo
Intervention Description
The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of placebo. Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation.
Primary Outcome Measure Information:
Title
Effect of the treatment on reduction of the HbA1c level (%)
Description
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at reducing the HbA1c level (%).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial glucose level
Description
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at reducing the post-prandial glucose level (mmol/L).
Time Frame
12 weeks
Title
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial insulin level
Description
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at modifying the post-prandial insulin level (microU/mL).
Time Frame
12 weeks
Title
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: fructosamine level
Description
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at modifying the fructosamine level (microU/mL).
Time Frame
12 weeks
Title
Effect of the treatment on evolution of the subject weight
Description
Evaluate the effect of a once daily administration of the cereal 1 or cereal 2 protein hydrolysate versus placebo, when consumed over a 12-week period, at reducing the weight (kg).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provide written informed consent, Be aged between 18 and 75 years, inclusive, Have a HbA1c of > 5.7% and < 6.4% (38.8mmol/mol- 47mmol/mol), Be a non-smoker or an ex-smoker (10 years or more), Have a body mass index (BMI) 20 - 35 kg/m², Have a stable bodyweight (+/- 5%) in the last 3 months (as self-reported by the subject), Be willing to maintain existing dietary habits and physical activity levels throughout the trial period, Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator. Exclusion Criteria: Diagnosed diabetes with a HbA1c >6.4% (47mmol/mol) Body Mass Index (BMI) less than 20 (underweight) or greater than 35 (morbidly obese) Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease or any condition which contraindicates, in the investigators judgement, entry to the study Consumption of more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females Currently or recently (within 3 months of study entry) taking any medication, which in the opinion of the investigator, could interfere with the outcome of the study, including insulin, acetylsalicylic acid, thyroxine etc. If subjects are taking hypolipidemic agents and/or beta-blockers Known allergy to any of the components of the test product History of drug or alcohol abuse Present or recent use (within 3 months of pre-screening) of dietary supplements that may affect the level of blood glucose, e.g. chromium, dietary fibres and non-digestible carbohydrates e.g. fructo-oligosaccharides chicory inulin, mulberry leaf extract, e.t.c (Note: There are many dietary supplements, both approved and unapproved, marketed for the regulation of blood glucose. The Principal Investigator will discuss any uncertain cases directly with the study sponsor prior to inclusion of any such subjects) Low hemoglobin or hematocrit (i.e., lower than normal ranges specified and in-use at the local laboratory designated for this study), Females are pregnant, lactating or wish to become pregnant during the study. Participation in a clinical trial with an investigational product within 90 days before pre-screening, or plans to participate in another study during the study period, Subject has a history of non-compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valdis Pirags, Prof.
Organizational Affiliation
P. Stradins University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
P. Stradins Clinical University Hospital
City
Riga
State/Province
LV
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Clinic "Adoria" SIA
City
Riga
State/Province
LV
ZIP/Postal Code
LV-1011
Country
Latvia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of a Plant-based Hydrolysates Daily Consumption on the HbA1c of Pre-diabetic Subjects

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