The effect of whole-food dairy products on blood sugar regulation, bone health and feelings of hunger
| ISRCTN | ISRCTN13531586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13531586 |
| Secondary identifying numbers | NL80607.096.22 |
- Submission date
- 13/05/2022
- Registration date
- 26/05/2022
- Last edited
- 18/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Dietary protein has several important health effects on muscle and bone tissue and is associated with several health outcomes such as reduced heart disease risk. In general, people have a skewed distribution of protein intake, with protein intakes at breakfast below the recommendations for optimal muscle health. Besides contributing to muscle and bone health, increasing protein intake with breakfast can aid in weight management, as increased protein intakes are associated with increased fullness following food intake. Also, consuming protein with carbohydrates is associated with a more favorable blood sugar response. Dairy protein may be a favourable protein source as it contains other nutrients that can substantially improve the quality of breakfast, such as vitamin B2 and B12, potassium, calcium and phosphorus. The benefits of (high doses of) isolated milk-derived nutrients for muscle health, blood sugar control, fullness, and bone metabolism have been well established. However, much of the evidence cannot be directly translated to daily life, as people consume mixed diets rather than isolated nutrients.
The main aim of this study is to assess metabolic responses when graded amounts of whole-food dairy products are incorporated into a common breakfast. The researchers also aim to explore the potential of jumping exercise to enhance the benefits of dairy on bone metabolism.
Who can participate?
Healthy volunteers aged 20 - 40 years
What does the study involve?
Within this study there are four experimental conditions (four test days). Participants undergo all these conditions in a random order. This order is determined by the computer.
Condition 1: Consuming a carbohydrate-rich breakfast with bread, margarine, jam and tea with sugar.
Condition 2: Consuming a breakfast with bread, margarine, jam and milk.
Condition 3: Consuming a breakfast with bread, margarine, cheese and milk.
Condition 4: Consuming a breakfast with bread, margarine, cheese and milk. After this breakfast, participants will perform a short jump exercise session.
What are the possible benefits and risks of participating?
Participants may experience some discomfort from some soreness in the legs after the jump training. Participants may experience some discomfort from the blood draw.
Where is the study run from?
HAN University of Applied Sciences (Netherlands)
When is the study starting and how long is it expected to run for?
January 2022 to October 2022
Who is funding the study?
1. FrieslandCampina (Netherlands)
2. Nederlandse Zuivel Organisatie (Netherlands)
Who is the main contact?
Luuk Hilkens
luuk.hilkens@han.nl
Contact information
Scientific
Kapittelweg 33
Nijmegen
6525 EN
Netherlands
| Phone | +31 (0)623644634 |
|---|---|
| luuk.hilkens@han.nl |
Study information
| Study design | Open-label randomized cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The postprandial metabolic response with graded amounts of whole-food dairy products as part of breakfast |
| Study acronym | DAYBREAK |
| Study objectives | The main objective of the current project is to assess postprandial metabolic responses when graded amounts of whole-food dairy products are incorporated into a common breakfast. Furthermore, the researchers aim to explore the potential of jumping exercise to enhance the benefits of dairy on bone metabolism. |
| Ethics approval(s) | Approved 21/04/2022, Medical Ethical Review Commission METC Zuyderland (Postbus 5500, 6130 MB, Sittard, The Netherlands, +31 (0)88 4590129, metc@zuyderland.nl), ref: METCZ20220015 |
| Health condition(s) or problem(s) studied | Nutritional study in healthy individuals |
| Intervention | Randomisation is carried out using a Williams Design Latin Square with four trial sequence possibilities. These four sequences are randomized in 2 blocks of 8 and 1 of 4, using an online randomization tool. Participants will be exposed to the following conditions in a randomized order: 1. Common high-carbohydrate breakfast: bread, tea with sugar, half-fat margarine and marmalade (LOW*) 2. Breakfast with milk: bread, milk, half-fat margarine and marmalade (MOD*) 3. Breakfast with milk and cheese: bread, milk, half-fat margarine, cheese (HIGH*) 4. Breakfast with milk and cheese: bread, milk, half-fat margarine, cheese. Followed by a ~5-min bout of jumping exercise to stimulate bone formation (HIGH+JUMP*). *LOW = low dairy intake (~10 g protein); SUB = moderate dairy intake (~16 g protein); HIGH = high dairy intake (~26 g protein); HIGH+JUMP = high dairy intake (~26 g protein) + ~5 min jumping exercise. The duration of the intervention per subject is 4 weeks (i.e. 4 test days separated by 1 week). |
| Intervention type | Behavioural |
| Primary outcome measure | Postprandial kinetics and bioavailability of amino acids measured using blood samples at baseline, 15, 30, 45, 60, 90, 120, 180, 240, and 300 minutes |
| Secondary outcome measures | 1. Glycaemic response measured using blood samples (glucose, insulin, GLP-1) at baseline, 15, 30, 45, 60, 90, 120, 180, 240, and 300 minutes 2. Bone metabolism measured using blood samples (calcium, PTH, CTX, P1NP) at baseline, 15, 30, 45, 60, 90, 120, 180, 240, 300 minutes, and 24 hours 3. Feelings of hunger and satiety measured using the visual analogue score (VAS) baseline, 60, 120, 180, 240, and 300 minutes |
| Overall study start date | 01/01/2022 |
| Completion date | 19/10/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 23 |
| Key inclusion criteria | 1. Males and females 2. Age ≥20 and ≤40 years. 3. BMI ≥18.5 and ≤27.5 kg/m² |
| Key exclusion criteria | 1. Blood donation during the study period 2. Currently smoking 3. Consumption of >21 alcoholic beverages per week 4. Use of illicit drugs 5. Regular use of protein or calcium supplements 6. A self-reported reported lactose intolerance, allergy or sensitivity to dairy ingredients 7. Reported slimming or medically prescribed diet 8. Use of antibiotics in the past month 9. Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease, rheumatoid arthritis, orthopaedic disorders, renal disease, liver disease, diabetes mellitus, inflammatory disease, cognitive impairment, and thyroid or parathyroid disease) 10. Use of medications known to interfere with selected outcome measures (i.e. corticosteroids) 11. (Chronic) injuries of the locomotor system that can interfere with the intervention 12. Current participation in another biomedical research study 13. Trained individuals (i.e. performing sport activities for more than 6 hours per week) 14. Structural or competitively participating in exercise/sports with a substantial high-impact component, such as soccer, volleyball, running, and lower body resistance training |
| Date of first enrolment | 16/05/2022 |
| Date of final enrolment | 13/09/2022 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Nijmegen
6525 EN
Netherlands
Sponsor information
University/education
Kapittelweg 33
Nijmegen
6525 EN
Netherlands
| Phone | +31 (0)24 353 0500 |
|---|---|
| JanWillem.vanDijk@han.nl | |
| Website | https://www.hanuniversity.com/en/ |
"ROR" |
https://ror.org/0500gea42 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- FrieslandCampina Nederland, FrieslandCampina N.V.
- Location
- Netherlands
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Dairy Association, NZO
- Location
- Netherlands
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication(s) in high-impact peer-reviewed journal(s) by the end of 2023. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Upon reasonable request by other researchers, raw data (Excel file) will be made available after the publication of the scientific reports. Data can be used for scientific peer-review or meta-analytic procedures. Data will be fully anonymised. Access to the datasets via JanWillem.vanDijk@han.nl. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/12/2023 | 18/12/2023 | Yes | No |
Editorial Notes
18/12/2023: Publication reference added.
11/10/2023: The registration was initiated on 13/05/2022 and finalised on 26/05/2022. Following the prospective submission on 13/05/2022, there were no subsequent changes to the protocol. The recruitment started on 16/05/2022, after the initiation of public registration. Due to a delay in processing the payment, the registration date is 26/05/2022, resulting in the official classification of the study as 'retrospective'.
20/10/2022: The following changes were made to the trial record:
1. Total final enrolment added.
2. The recruitment end date was changed from 01/12/2022 to 13/09/2022.
3. The overall trial end date was changed from 31/12/2022 to 19/10/2022.
16/05/2022: Trial's existence confirmed by the Medical Ethical Review Commission METC Zuyderland.
