Status:
COMPLETED
Effect of a Plant-based Hydrolysates Daily Consumption on the HbA1c of Pre-diabetic Subjects
Lead Sponsor:
Onorach Clinical Ltd
Conditions:
Pre-diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
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 re...
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 eva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03851666
Start Date
August 9 2018
End Date
October 31 2019
Last Update
November 4 2019
Active Locations (2)
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1
P. Stradins Clinical University Hospital
Riga, LV, Latvia, LV-1002
2
Clinic "Adoria" SIA
Riga, LV, Latvia, LV-1011