Pre-diabetesNCT03851666
Effect of a Plant-based Hydrolysates Daily Consumption on the HbA1c of Pre-diabetic Subjects
A study testing 12 weeks daily administration Cereal 1 and 12 weeks daily administration Cereal 2 in people with Pre-diabetes, run by Onorach Clinical Ltd at 2 sites in Latvia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- 12 weeks daily administration Cereal 1 and 12 weeks daily administration Cereal 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesLatvia
- Study dates
- 9 Aug 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Latvia2 sites
P. Stradins Clinical University Hospital
Riga, LV, LV-1002
Clinic "Adoria" SIA
Riga, LV, LV-1011
About this study
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.
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.
Read the 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.
- Conditions
- Pre-diabetes
- Being tested
- 12 weeks daily administration Cereal 1, 12 weeks daily administration Cereal 2, 12 weeks daily administration Placebo
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks daily administration Cereal 1Dietary supplement
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.
12 weeks daily administration Cereal 2Dietary supplement
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.
12 weeks daily administration PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 12 weeks daily administration Placebo | Placebo comparator | Intervention: 12 weeks daily administration. The placebo is a powder: microcrystalline cellulose. The daily dose administrated is 15 grams. Receives: Other: 12 weeks daily administration Placebo |
| 12 weeks daily administration Cereal 1 | Experimental | 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. Receives: Dietary Supplement: 12 weeks daily administration Cereal 1 |
| 12 weeks daily administration Cereal 2 | Active comparator | 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. Receives: Dietary Supplement: 12 weeks daily administration Cereal 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 12 weeks
Secondary outcomes (4)
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start9 Aug 2018
- Primary completion9 Jul 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onorach Clinical Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valdis Pirags, Prof., Principal investigator, P. Stradins University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851666
- Sponsor's protocol ID
- NRT-pep-DB-01
- Status last verified
- Nov 2019
- First submitted
- 15 Feb 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03851666
- Acronym / sponsor ID
- NRT-pep-DB-01
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Onorach Clinical LtdUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12 weeks daily administration Placebo | Placebo comparator | Other: 12 weeks daily administration PlaceboIntervention: 12 weeks daily administration. The placebo is a powder: microcrystalline cellulose. The daily dose administrated is 15 grams. |
| 12 weeks daily administration Cereal 1 | Experimental | Dietary Supplement: 12 weeks daily administration Cereal 1Intervention: 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. |
| 12 weeks daily administration Cereal 2 | Active comparator | Dietary Supplement: 12 weeks daily administration Cereal 2Intervention: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12 weeks daily administration Cereal 1The 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. | Dietary supplement | 12 weeks daily administration Cereal 1 |
| 12 weeks daily administration Cereal 2The 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. | Dietary supplement | 12 weeks daily administration Cereal 2 |
| 12 weeks daily administration PlaceboThe 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. | Other | 12 weeks daily administration Placebo |
Primary outcome
Effect of the treatment on reduction of the HbA1c level (%)
Time frame: 12 weeks
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 (%).
4 secondary outcomes
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial glucose level
Time frame: 12 weeks
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial insulin level
Time frame: 12 weeks
Effect of the treatment on evolution of another parameter related to pre-diabetic condition: fructosamine level
Time frame: 12 weeks
Effect of the treatment on evolution of the subject weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valdis Pirags, Prof. principal investigator
P. Stradins University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 weeks daily administration Cereal 1 and 12 weeks daily administration Cereal 2 in people with Pre-diabetes, run by Onorach Clinical Ltd at 2 sites in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the treatment on reduction of the HbA1c level (%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.