Milk proteins for glycemic management
| ISRCTN | ISRCTN61079365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61079365 |
| Secondary identifying numbers | CGM |
- Submission date
- 19/12/2016
- Registration date
- 21/12/2016
- Last edited
- 07/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Milk is an excellent source of protein and other key nutrients. Many proteins found in milk are caseins, which can be broken down into protein fragments (peptides). Bioactive peptides are protein fragments that have a beneficial effect on health. There is evidence to suggest that casein bioactive peptides have beneficial effects on health, in particular the cardiovascular (circulatory) system and immune system. Some research has suggested that milk-derived protein supplements (hydrolysates) may have potential health benefits in terms of managing blood sugar levels. The aim of this study is to examine the ability of three different types of protein drinks to help maintain good blood sugar control.
Who can participate?
Healthy adults aged between 40 and 65 years.
What does the study involve?
Participants are randomly allocated receive three treatments in a random order. Each treatment lasts for three days and there is day period between each treatment where participants follow their normal diet. The first treatment involves drinking a protein drink containing intact casein twice a day at breakfast time and in the evening for three days. The second and third treatments involve drinking a protein drink containing protein hydrolysate A and protein hydrolysate B respectively (two different milk-derived protein supplements). The study period lasts for a total of 14 days, during which participants wear a special device which automatically and continuously monitors their blood sugar levels.
What are the possible benefits and risks of participating?
There are no direct benefits to the participants but this study should help researchers gain a better understanding of how ingredients that are potentially beneficial work. There are no notable risks involved with participating.
Where is the study run from?
University College Dublin (Ireland)
When is the study starting and how long is it expected to run for?
June 2016 to June 2018
Who is funding the study?
Enterprise Ireland (Ireland)
Who is the main contact?
Professor Lorraine Brennan
Contact information
Scientific
University College Dublin Institute of Food and Health
Dublin
D4
Ireland
Study information
| Study design | Randomised cross over intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Examination of the effect of milk proteins on glycemic management |
| Study objectives | A protein hydrolysate will help glycemic management over and above the intact parent protein. |
| Ethics approval(s) | UCD Human Ethics committee, 12/04/2016, ref: LS-16-13-Brennan |
| Health condition(s) or problem(s) studied | Diabetes risk |
| Intervention | Participants will be randomised to receive three treatments in a random order. There will be a washout period of 2 days between each arm, where participants follow their normal diet. Treatment 1: Protein drink containing intact casein Treatment 2: Protein drink containing protein hydrolysate A Treatment 3: Protein drink containing protein hydrolysate B In all treatments, the protein drink will be consumed twice daily for 3 days as part of study breakfast and evening meals. Follow up involves wearing the FreeStyle Libre continuous glucose monitoring system for 14 days in order to monitor glucose levels. |
| Intervention type | Supplement |
| Primary outcome measure | Glucose levels are measured using the FreeStyle Libre continuous glucose monitoring system continuously for the 14 days of the study. |
| Secondary outcome measures | Glucose control throughout the day is measured using the FreeStyle Libre continuous monitoring system continuously for the 14 days of the study. |
| Overall study start date | 01/06/2016 |
| Completion date | 01/06/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | Healthy adults aged 40-65 years |
| Key exclusion criteria | 1. BMI < 25kg/m2, BMI >35kg/m2, 2. Any diagnosis of disease or the taking of any medication (except the OCP) 3. Pregnancy or lactation 4. An allergy or intolerance to dairy or wheat products 5. Known allergy to medical grade adhesive |
| Date of first enrolment | 01/10/2016 |
| Date of final enrolment | 01/09/2017 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D4
Ireland
Sponsor information
University/education
University College Dublin Institute of Food and Health
Dublin
D4
Ireland
"ROR" |
https://ror.org/01nvbq395 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Location
- Ireland
Results and Publications
| Intention to publish date | 01/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2019 | Yes | No |
Editorial Notes
07/01/2019: Publication reference added.
