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

NCT03851666 | Completed

• 1 other identifier: NRT-pep-DB-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  12 weeks

Secondary Outcomes (4)

• Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial glucose level

  12 weeks

• Effect of the treatment on evolution of another parameter related to pre-diabetic condition: post-prandial insulin level

  12 weeks

• Effect of the treatment on evolution of another parameter related to pre-diabetic condition: fructosamine level

  12 weeks

• Effect of the treatment on evolution of the subject weight

  12 weeks

Study Arms (3)

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.

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.

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.

Dietary Supplement: 12 weeks daily administration Cereal 2

Interventions

12 weeks daily administration Cereal 1 DIETARY_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 1

12 weeks daily administration Cereal 2 DIETARY_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 2

12 weeks daily administration Placebo OTHER

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.

12 weeks daily administration Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Onorach Clinical Ltd: lead

Study Sites (2)

P. Stradins Clinical University Hospital

Riga, LV, LV-1002, Latvia

Location

Clinic "Adoria" SIA

Riga, LV, LV-1011, Latvia

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Valdis Pirags, Prof.

  P. Stradins University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 22, 2019
• Study Start: August 9, 2018
• Primary Completion: July 9, 2019
• Study Completion: October 31, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Locations

LA (2)