Effect of Protein Hydrolysates on HbA1c Levels in Pre-diabetics

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03083600
• Date of registration: 27/02/2017
• Prospective Registration: Yes
• Primary sponsor: Atlantia Food Clinical Trials
• Public title: Effect of Protein Hydrolysates on HbA1c Levels in Pre-diabetics
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Study to Assess Efficacy and Safety of Protein Hydrolysates in the Reduction and Maintenance of HbA1c Levels in a Pre-diabetic Population
• Date of first enrolment: May 22, 2017
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03083600
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Fergus Shanahan, MD
• Affiliation: Cork University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Provide written informed consent,

2. Be aged between 18 and 75 years, inclusive,

3. Have a HbA1c of > 5.7% and < 6.4% (38.8mmol/L - 47mmol/L),

4. Be a non-smoker,

5. Have a body mass index (BMI) 20 - 35 kg/m²,

6. Have a stable bodyweight (+/- 5%) in the last 3 months,

7. Not currently taking regular supplements (within 1 month of study entry),

8. Be willing to maintain dietary habits and physical activity levels throughout the
trial period,

9. 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:

1. Diagnosed diabetes with a HbA1c >6.4% (47mmol/l)

2. Body Mass Index (BMI) less than 20 (underweight) or greater than 35 (morbidly obese)

3. 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

4. Consumption of more than the recommended alcohol guidelines i.e. >21 alcohol
units/week for males and >14 units/week for females

5. 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 and acetylsalicylic acid

6. If subjects are taking hypolipidemic agents and/or beta-blockers, their dose must be
stable for greater than 3 months,

7. Known allergy to any of the components of the test product

8. History of drug or alcohol abuse

9. Present or recent use (within 3 months of screening) of dietary supplements that
affect the level of blood glucose, e.g chromium,

10. Low hemoglobin or hematocrit (i.e., lower than accepted laboratory values),

11. Females are pregnant, lactating or wish to become pregnant during the study. Female
subject is currently either of:

- non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
including any female who is post-menopausal or any female who is surgically
sterilized (via documented hysterectomy or bilateral tubal ligation). (For
purposes of this study, postmenopausal is defined as one year without menses), OR

- child bearing potential, the subject is eligible to enter and participate in this
study if she is not lactating and has a negative urine pregnancy test at the
screening visit, visit 2 and upon completion of the study at visit 5. The subject
must also agree to one of the following methods of contraception: i. Complete
abstinence from intercourse two weeks prior to administration of study drug,
throughout the clinical trial, until the completion of follow-up procedures or
for two weeks following discontinuation of the study medication in cases where
subject discontinues the study prematurely. (Subjects utilizing this method must
agree to use an alternate method of contraception if they should become sexually
active and will be queried on whether they have been abstinent in the preceding 2
weeks when they present to the clinic for the Final Visit.) or, ii. has a male
sexual partner who is surgically sterilized prior to the Screen Visit and is the
only male sexual partner for that subject or, iii. sexual partner(s) is/are
exclusively female or, iv. Oral contraceptives (either combined or progestogen
only) with double-barrier method of contraception consisting of spermicide with
either condom or diaphragm. (Women of child-bearing potential using an oral
contraceptive in combination with a double-barrier method of contraception are
required to continue to use this form of contraception for 1 week following
discontinuation of study medication).

v. Use of double-barrier contraception, specifically, a spermicide plus a
mechanical barrier (e.g. male condom, female diaphragm). The subject must be
using this method for at least 1 week following the end of the study or, vi. Use
of any intrauterine device (IUD) with published data showing that the highest
expected failure rate is less than 1% per year. The subject must have the device
inserted at least 2 weeks prior to the first Screen Visit, throughout the study,
and 2 weeks following the end of the study.

12. Participation in a clinical trial with an investigational product within 90 days
before screening, or plans to participate in another study during the study period,

13. Subject has a history of non-compliance



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

PreDiabetes

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: Plant-based Protein Hydrolysate 1

Dietary Supplement: Plant-based Protein Hydrolysate 2

Primary Outcome(s)

Plasma Glycated Haemoglobin (HbA1c) (mmol/mol) [Time Frame: 12-weeks]

Secondary Outcome(s)

Blood pressure (mmHg) [Time Frame: 12-weeks]

Post-prandial blood glucose (mmol/L) [Time Frame: 12-weeks]

Weight (kg) [Time Frame: 12-weeks]

Post-prandial blood insulin (pmol/L) [Time Frame: 12-weeks]

Secondary ID(s)

AFCRO-071

Source(s) of Monetary Support

Please refer to primary and secondary sponsors