Do feed-induced nutrient differences in cattle meat affect consumers’ health?

ISRCTN	ISRCTN25014465
DOI	https://doi.org/10.1186/ISRCTN25014465
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	The Norwegian Agriculture Agency Grant no 224794
Sponsor	Norwegian Agriculture Agency
Funder	Norwegian Agriculture Agency

Submission date: 17/12/2021
Registration date: 21/12/2021
Last edited: 18/07/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Bovine meat (beef) is a valuable food source providing nutrients that are vital for good health. However, red meat has been given negative attention due to concerns for greenhouse gasses and links between red meat and risk for non-communicable chronic diseases. The aim of the study was to investigate the health effects of the optimized beef (from bulls fed with extra supplementation of selenium, vitamin D, E, K and omega-3 [Nutrient optimized, SeDK-feed]) compared to regular beef (from bulls fed with regular feed concentrate.

Who can participate?
Healthy, young, normal-weight females could participate.

What does the study involve?
A total of 34 free-living young healthy women consumed 300g of raw weight beef per day of one of the two beef types in a cross-over design. Diet registrations and fasting blood samples, anthropometric and clinical data were collected four times.

What are the possible benefits and risks of participating?
The possible benefit to the participants is that they learn how an intervention is carried out. The risk of participating is negligible beyond the discomfort possible with blood sampling.

Where is the study run from?
The Norwegian University of Life Sciences

When is the study starting and how long is it expected to run for?
September 2014 to April 2017

Who is funding the study?
The Norwegian Agriculture Agency Grant no 224794

Who is the main contact?
Professor Anna Haug, anna.haug@nmbu.no

Contact information

Prof Anna Haug
Scientific

Arboretveien 6
Faculty of Biosciences
Norwegian University of Life Sciences
Ås
1433
Norway

ORCID ID	0000-0003-4704-699X
Phone	+47 99253637
Email	anna.haug@nmbu.no

Prof Bjørg Egelandsdal
Scientific

Postbox 5003 Christian Falsens vei 1
Ås
1433
Norway

ORCID ID	0000-0003-0877-4628
Phone	+47 93847125
Email	bjorg.egelandsdal@nmbu.no

Study information

Primary study design	Interventional
Study design	Double blind randomized cross over clinical trial
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
Scientific title	Identification of the healthiest beef meat for Norwegian women
Study objectives	1. Optimize beef meat for healthiness regarding nutrients 2. Study the healthiness of optimized beef meat in humans
Ethics approval(s)	Approved 06/01/2017, The Norwegian National Research Ethics Committee, Regional Committees for Medical and Health Research Ethics (Kongens gate 14, 0153 Oslo, Norway; + (47) 23 31 83 00; post@forskningsetikk.no), ref: 2016/620
Health condition(s) or problem(s) studied	Changes in health parameters after ingestion of optimized beef meat
Intervention	The crossover clinical study is carried out for 32 days and contain two intervention periods, each lasts 6 days, with 14 days of washout. During each intervention period, the participants consume 300 g minced beef meat (as raw weight, regular or optimized beef) from forequarters, in combination with their chosen habitual food items, except fish in random order. The meat is from bulls fed regular control composite feed (REGULAR beef), and from bulls fed composite feed supplemented with vitamins D, E, K, omega-3 and selenium (SeDK-beef). The minced beef meat from the SeDK animals contain more selenium (+26%), vitamin MK4 (+123%), vitamin D (+197%), vitamin E (+318%) and has a lower omega-6/omega-3 ratio (-24%) compared to the REGULAR beef. The participants are randomly split into 2 groups (2x17 persons) where one group is given the treatment (feed fortified cattle meat SeDK) and the other group is given a regular feed (REGULAR) mimicking commercial feed. The randomization is done in Excel using RANDARRAY. Blood sampling, blood pressure, heart rate, and selected anthropometric measurements are carried out before receiving the test product. All participants are given the coded test product on the same start-up day. The coded meat product is handed out by persons who do not know what the code means. It is impossible to visually see the differences between test products, so each product just has a code. The participants start consuming the test product the very same day and 5 consecutive days (sum 6 test days). Then the participants return for blood sampling, blood pressure, heart rate, and selected anthropometric measurements before entering the wash-out period (14 days). Thereafter, the same procedure is repeated one more time. The order of arriving for the blood sampling etc is semi-randomized as adaptation to public transport and lectures are accepted. The blood sampling is done in a Medical centre (Follo Bedriftshelsetjeneste, Ås, Norway), the participants are informed immediately regarding border values like low blood hemoglobin values while the intervention leader informs about border clinical values as soon as the analytical data are received from the analytical centre (Fürst medisinske senter, Oslo, Norway). The intervention leader has close communication regarding any questions the participants may have during the interventions and advise them regarding their diet registrations. Finally, the intervention leader invited the participants for a general meeting after the intervention about the general nutrient issues of young females. Finally, each participant is formally interviewed 4 times during the intervention using a set of fixed questions/survey forms. As an example, they are asked about their perception of satiety related to their diet changes.
Intervention type	Other
Primary outcome measure(s)	Blood values are measured 4 times; before and after the 2 test diet periods of 6 days) 1. Blood glucose mmol/L blood 2. Insulin pmol/L serum 3. C-peptide pmol/L serum 4. AST U/L serum 5. ALT U/L serum 6. AST/ALT 7. IL-1β ng/L plasma 8. IL-6 ng/L plasma 9. IL-8 ng/L plasma 10. HB g/100 ml blood 11. Triacylglycerol mmol/L serum 12. LDL-cholesterol mmol/L serum 13. HDL-cholesterol mmol/L serum 14. Selenium µg/L serum 15. Phylloquinone µg/L plasma 16. MK7 µg/L plasma 17. 25-OH D3 nmol/L serum 18. RNA deep sequencing of leucocytes isolated from fresh (10 min) plasma.
Key secondary outcome measure(s)	1. Test meat nutrient content (before the study starts) per 100g: 1.1. Selenium, µg 1.2. alpha-tocopherol, mg 1.3. K1, µg 1.4. MK4, µg 1.5. Vit D3, µg 1.6. 25-OH-D3, µg 1.7. Vitamin K 1.8. Cholesterol, mg 1.9. Fat, g 1.10. Fatty acid composition, mg 2. Diet registration (4 times; before and after the 2 test diet periods of 6 days) 3. Complete registration of what the participants ate (4 x 3 days are requested) Computer tool used: Norwegian Directorate of Health/Norwegian Food Safety Authority. (2021). A diet tool from the Norwegian Directorate of Health and the Norwegian Food Safety Authority. Kostholdsplanleggeren (in Norwegian and English), available at: https://www.kostholdsplanleggeren.no/ Measured before and after the 2 test diet periods of 6 days): 4. Bodyweight (kg) 5. BMI (kg/m²) 6. Blood pressure (mmHg) 7. Pulse (bpm) 8. Satiety by questionnaire
Completion date	15/04/2017

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	30 Years
Sex	Female
Target sample size at registration	35
Total final enrolment	35
Key inclusion criteria	1. Women 2. Age (18-30 years) 3. BMI (18-28 kg/m²) 4. No medicine (except birth control pills)
Key exclusion criteria	1. Intake of medicine 2. Not perceive themselves as sick 3. Obesity
Date of first enrolment	10/01/2017
Date of final enrolment	15/01/2017

Locations

Countries of recruitment

Norway

Study participating centre

The Norwegian University of Life Sciences

Christian Falsens vei 1
Faculty of Chemistry, Biotechnology and Food Science
Ås
Postbox 5003/ 1433
Norway

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The raw data will be submitted to the journal of choice.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		22/02/2022	18/07/2022	Yes	No
Dataset		08/02/2022	18/07/2022	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	in Norwegian	01/11/2021	21/12/2021	No	No
Protocol file	in English	22/03/2016	22/12/2021	No	No
Statistical Analysis Plan			21/12/2021	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

40829 Protocol.pdf: in Norwegian
40829 Statistical analysis plan.pdf: Statistical Analysis Plan
40829 Protocol in English 22Mar2016.pdf: in English

Editorial Notes

18/07/2022: Publication reference and data link added.
22/12/2021: The English translation of the protocol was uploaded as an additional file.
21/12/2021: Trial's existence confirmed by The Norwegian National Research Ethics Committee.