Effect of Protein Hydrolysates on HbA1c Levels in Pre-diabetics

NCT03083600 | Terminated

• 1 other identifier: AFCRO-071
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of three different daily doses of plant protein hydrolysates versus placebo, when consumed over a 12-week period, at reducing and maintaining glycated haemoglobin (HbA1c) levels in a pre-diabetic population (otherwise healthy subjects with impaired glucose metabolism). To evaluate the effectiveness of three different daily doses of pea or rice protein hydrolysates versus placebo, when consumed over a 12-week period on: post-prandial glucose/insulin levels (oral glucose tolerance test, fructosamine levels, fasting plasma glucose levels, vital signs, physical examinations, weight and blood pressure.

Conditions

PreDiabetes

Keywords

protein hydrolysates; HbA1c; prediabetes

Outcome Measures

Primary Outcomes (1)

• Plasma Glycated Haemoglobin (HbA1c) (mmol/mol)

  5, 10, 15 g Plant-based protein hydrolysate (1 or 2) vs placebo

  12-weeks

Secondary Outcomes (4)

• Post-prandial blood glucose (mmol/L)

  12-weeks

• Post-prandial blood insulin (pmol/L)

  12-weeks

• Weight (kg)

  12-weeks

• Blood pressure (mmHg)

  12-weeks

Study Arms (7)

Plant-based Protein Hydrolysate (1) 5g

ACTIVE COMPARATOR

plant-based protein hydrolysate 1 (5g) stored in aluminium sachets to be reconstituted with 100 mL of water and administered 2 times per day for 12-weeks

Dietary Supplement: Plant-based Protein Hydrolysate 1

Plant-based Protein Hydrolysate (1) 10g

ACTIVE COMPARATOR

Plant-based protein hydrolysate 1 (10 g) stored in aluminium sachets to be reconstituted with 100 mL of water and administered 2 times daily for 12-weeks

Dietary Supplement: Plant-based Protein Hydrolysate 1

Plant-based Protein Hydrolysate (1) 15 g

ACTIVE COMPARATOR

Plant-based 1 protein hydrolysate (15 g) stored in aluminium sachets to be reconstituted with 100 mL of water and administered 2 times daily for 12-weeks

Dietary Supplement: Plant-based Protein Hydrolysate 1

Placebo

PLACEBO COMPARATOR

Cellulose Placebo stored in aluminium sachets to be reconstituted with 100 mL of water and administered 2 times daily for 12-weeks.

Dietary Supplement: Placebo

Plant-based Protein Hydrolysate (2) 5g

ACTIVE COMPARATOR

Plant-based protein hydrolysate 2 (5 g) stored in aluminium sachets to be reconstituted with 100 mL of water and administered 2 times daily for 12-weeks

Dietary Supplement: Plant-based Protein Hydrolysate 2

Plant-based Protein Hydrolysate (2) 10g

ACTIVE COMPARATOR

Plant-based protein hydrolysate 2 (10 g) stored in aluminium sachets to be reconstituted with 100 mL of water and administered 2 times daily for 12-weeks

Dietary Supplement: Plant-based Protein Hydrolysate 2

Plant-based Protein Hydrolysate (2) 15g

ACTIVE COMPARATOR

Plant-based protein hydrolysate 2 (15 g) stored in aluminium sachets to be reconstituted with 100 mL of water and administered 2 times daily for 12-weeks

Dietary Supplement: Plant-based Protein Hydrolysate 2

Interventions

Plant-based Protein Hydrolysate 1 DIETARY_SUPPLEMENT

Plant-based Protein Hydrolysate 2 for 12-weeks

Plant-based Protein Hydrolysate (1) 10g; Plant-based Protein Hydrolysate (1) 15 g; Plant-based Protein Hydrolysate (1) 5g

Plant-based Protein Hydrolysate 2 DIETARY_SUPPLEMENT

Plant-based Protein Hydrolysate 2 for 12-weeks

Plant-based Protein Hydrolysate (2) 10g; Plant-based Protein Hydrolysate (2) 15g; Plant-based Protein Hydrolysate (2) 5g

Placebo DIETARY_SUPPLEMENT

Cellulose Placebo for 12-weeks

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/L - 47mmol/L),
• Be a non-smoker,
• Have a body mass index (BMI) 20 - 35 kg/m²,
• Have a stable bodyweight (+/- 5%) in the last 3 months,
• Not currently taking regular supplements (within 1 month of study entry),
• Be willing to maintain 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/l)
• 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 and acetylsalicylic acid
• If subjects are taking hypolipidemic agents and/or beta-blockers, their dose must be stable for greater than 3 months,
• 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 screening) of dietary supplements that affect the level of blood glucose, e.g chromium,
• Low hemoglobin or hematocrit (i.e., lower than accepted laboratory values),
• 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.
• 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,

Sponsors & Collaborators

• Atlantia Food Clinical Trials: lead

Study Sites (1)

Atlantia Food Clinical Trials, University College Cork

Cork, Munster, T12 H2TK, Ireland

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Fergus Shanahan, MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, computer-generated randomisation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 56 participants randomised to receive: 5g, 10g, 15g Pea Protein Hydrolysate v placebo 5g, 10g, 15g v Rice Protein Hydrolysate v placebo

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 20, 2017
• Study Start: May 22, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)