Effects of meat and dairy fat on human health
ISRCTN | ISRCTN39863778 |
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DOI | https://doi.org/10.1186/ISRCTN39863778 |
Secondary identifying numbers | 281297 |
- Submission date
- 26/01/2022
- Registration date
- 22/03/2022
- Last edited
- 07/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
The dietary intake of saturated fatty acids (SFAs) from dairy and meat products has been associated with negative health effects, especially on the cardiovascular system (heart and blood vessels). Meat and dairy products contribute 62% of the total SFA intake from the average Norwegian diet. There is a lack of causal evidence between SFA and heart disease. In addition, it is unknown whether sources of SFA, such as dairy, pork and cattle, could affect heart disease risk differently. The aim of this study is to investigate whether different animal products (two types of cheese, beef and pork meat) affect health parameters in healthy young individuals.
Who can participate?
Men and women aged between 18 and 40 years, body mass index (BMI) between 18.5 and 30 kg/m², healthy, and with less than 10 hours of physical activity per week
What does the study involve?
Participants consume four different diets in a random order, each lasting 2 weeks followed by a 2-week break. The total duration of the study is 4 months. All participants receive a varied healthy diet plus one of the test products (150 g of cheese or 225 g of pork or 230 g of beef, respectively) for 2 weeks. During this period, the participants should only eat the food items provided. The diets are provided by the researchers and include a healthy diet (rich in fruits, vegetables and fiber) plus one of the four sources of animal fat: gouda cheese, Swiss cheese, beef or pork. Before and after each intervention period fasting blood, faeces and urine samples are collected (eight times in total). In addition, at the start and during the three break periods, all participants record everything they eat for 3 days.
Where is the study run from?
Norwegian University of Life Sciences (NMBU) (Norway)
When is the study starting and how long is it expected to run for?
July 2018 to October 2022
Who is funding the study?
The Norwegian Agriculture Agency (Norway)
Who is the main contact?
Bjørg Egelandsdal
bjorg.egelandsdal@nmbu.no
Contact information
Scientific
Postbox 5003 Christian Falsens vei 1
Aas
1433
Norway
0000-0003-0877-4628 | |
Phone | +47 (0)93847125 |
bjorg.egelandsdal@nmbu.no |
Scientific
Postbox 5003 Christian Falsens vei 1
Aas
1433
Norway
0000-0002-1652-8083 | |
Phone | +47 (0)67 23 29 55 |
milena.monfort-pires@nmbu.no |
Scientific
Arboretveien 6
Faculty of Biosciences
Aas
1433
Norway
0000-0003-4704-699X | |
Phone | +47 (0)99253637 |
anna.haug@nmbu.no |
Study information
Study design | Crossover clinical trial |
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Primary study design | Interventional |
Secondary study design | Randomised cross over trial |
Study setting(s) | Home |
Study type | Quality of life |
Participant information sheet | 41021_PIS_23Jan22.pdf |
Scientific title | Effects of lipid composition and structure in meat and dairy foods on digestibility and low-grade inflammation in cells, animals and humans |
Study acronym | LIG-IN-one |
Study objectives | To investigate how different animal fat sources (from cheese, beef and pork) affect human health. |
Ethics approval(s) | Approved 26/09/2020, The Norwegian National Research Ethics Committee, Regional Committees for Medical and Health Research Ethics (Kongens gate 14, 0153 Oslo, Norway; +47 (0)23 31 83 00; post@forskningsetikk.no), ref: 139404 |
Health condition(s) or problem(s) studied | Health/metabolic effects of healthy diets with cheese, beef or pork meat |
Intervention | The study has a crossover design with four different diets. The randomization is carried out according to a Latin square design in order to assure that all test diets are equally distributed. Each of the four diets is carried out for 2 weeks followed by 2 weeks of washout in a crossover design. The test diets are provided by the researchers and include a healthy diet (rich in fruits, vegetables and fiber) plus one of the four sources of animal fat: gouda-type cheese (150 g), Swiss-type cheese (150 g), beef (230 g) and pork meat (225 g), to be eaten in two or three meals. |
Intervention type | Behavioural |
Primary outcome measure | Blood values measured eight times; before and after the four test diet periods of 14 days: 1. Total serum triacylglycerol (before and after 14 days of each intervention) (mmol/l) 2. HDL-cholesterol (before and after 14 days of each intervention) (mmol/l) 3. LDL-cholesterol (before and after 14 days of each intervention) (mmol/l) Serum lipids are measured using accredited methods at a commercial medical laboratory in Norway. The changes in the lipid profile before and after the dietary interventions will be the primary outcome (mmol/l) 4. Inflammatory markers (interleukin-1 beta and interleukin-6) measured by enzyme-linked immunosorbent assay (ELISA) using fasting serum samples before and after 14 days of each intervention (pg/ml) |
Secondary outcome measures | Measured at fasting using accredited methods at a commercial medical laboratory in Norway using serum samples taken before and after the four test diet periods of 14 days: 1. ALT 2. AST 3. Insulin 4. C-reactive protein 5. Blood glucose 6. C-peptide pmol/L serum 7. 25-OH D3 nmol/L serum 8. Apolipoprotein A 9. Apolipoprotein B 10. Calcium 11. Ferritin 12. Iron 13. Vitamin B12 14. Lipid species (metabolites) measured by chromatography coupled to mass spectrometry-based metabolomics using serum samples. Calculated as fold changes in relation to pre-intervention values 15. Diet registration: collected four times at baseline and during the three washout periods (3 days in each period, totalling 12 days of diet registration). 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 four test diet periods of 14 days: 16. Bodyweight measured using the Tanita TBF-300A Body Composition Analyzer scale 17. Height measured using a portable stadiometer (Charder HM200P Portstad Portable Stadiometer) 18. BMI calculated as body weight (in kg) divided by the height in meters squared 19. Blood pressure measured using an A&D medical automatic blood pressure monitor (A&D, Tokyo, Japan) 20. Pulse measured using an A&D medical automatic blood pressure monitor (A&D, Tokyo, Japan) 21. Microbiota measurements of feces using 16S rRNA sequencing with Illumina |
Overall study start date | 01/07/2018 |
Completion date | 01/10/2022 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 40 Years |
Sex | Both |
Target number of participants | 40 |
Total final enrolment | 50 |
Key inclusion criteria | 1. Men and women 2. Age between 18 and 40 years 3. BMI between 18.5 and 30 kg/m² 4. Healthy 5. Less than 10 hours of physical activity per week |
Key exclusion criteria | 1. Use of any medication except birth control pills 2. Not consuming meat and/or dairy products 3. Willing to lose body weight 4. Food allergies 5. Problems with blood withdrawal or low blood pressure. |
Date of first enrolment | 01/10/2020 |
Date of final enrolment | 28/02/2021 |
Locations
Countries of recruitment
- Norway
Study participating centre
Aas
1433
Norway
Sponsor information
Government
Stortingsgata 28
Oslo
0161
Norway
Phone | +47 (0)78 60 60 00 |
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postmottak@landbruksdirektoratet.no | |
Website | https://www.landbruksdirektoratet.no |
https://ror.org/03ht51987 |
Funders
Funder type
Government
No information available
Results and Publications
Intention to publish date | 15/01/2023 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Stored in publicly available repository |
Publication and dissemination plan | The researchers plan to write one publication in a peer-reviewed journal |
IPD sharing plan | The raw data as used in a scientific publication will be stored at https://archive.sigma2.no. To this file the researchers will add a DOI number that will link to the raw data. Provided acceptable to the journal the DOI number linking to the raw data will be sent to the accepting journal. Once the paper is published the raw data are accessible to everyone upon request. The data will be anonymized and the information form (invitation form) specifies that the data will be used for publication. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Participant information sheet | 23/01/2022 | 16/03/2022 | No | Yes | |
Protocol file | 15/03/2022 | 16/03/2022 | No | No | |
Statistical Analysis Plan | 16/03/2022 | No | No | ||
Results article | Lipidomics results | 03/03/2023 | 07/08/2023 | Yes | No |
Additional files
Editorial Notes
07/08/2023: Publication reference added.
20/12/2022: The intention to publish date was changed from 15/10/2022 to 15/01/2023.
16/03/2022: Trial's existence confirmed by The Norwegian National Research Ethics Committee, Regional Committees for Medical and Health Research Ethics.