Effects of lipid composition and structure in meat and dairy foods on digestibility and low-grade inflammation in cells, animals and humans -Postprandial part
| ISRCTN | ISRCTN50747444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50747444 |
| Secondary identifying numbers | National Research Council: 281297; National ethic committee approval number: 139404 |
- Submission date
- 25/10/2024
- Registration date
- 28/10/2024
- Last edited
- 28/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
This study aims to investigate how different types of animal fats from dairy and meat products affect feelings of fullness and hunger. Previous research has shown that saturated fats from these sources can negatively impact heart health. Since dairy and meat make up a significant portion of the Norwegian diet, this study will look at how these fats influence satiety (the feeling of being full).
Who can participate?
Healthy men and women aged 18 to 40 years, with normal body weight and less than 10 hours of physical activity per week, can participate in this study.
What does the study involve?
Participants will arrive fasting in the morning and receive one of two test breakfasts, which include either semi-hard cheese or pork sausage along with bread, tomatoes, and juice. Blood samples will be taken before and after the meal, and then every 30 to 60 minutes for up to 240 minutes. After this, participants can eat as much as they want from a buffet, and their food intake will be recorded. Participants will also rate their hunger, fullness, desire to eat, and prospective food consumption throughout the session. Four weeks later, participants will return to repeat the process with the other test meal.
What are the possible benefits and risks of participating?
Participants will contribute to important research that could improve understanding of how different fats affect satiety and overall health. There are minimal risks involved, mainly related to blood sample collection, such as slight discomfort or bruising.
Where is the study run from?
The study is conducted at The Norwegian University of Life Sciences (NMBU) in Norway.
When is the study starting and how long is it expected to run for?
September 2020 to July 2025
Who is funding the study?
The study is funded by The Norwegian Agriculture Agency.
Who is the main contact?
Prof. Bjørg Egelandsdal (bjorg.egelandsdal@nmbu.no).
Contact information
Public, Scientific
Postbox 5003 Christian Falsens vei 1
Ås
1433
Norway
 ORCID ID |
0000-0003-0877-4628 |
|---|---|
| Phone | +47 917 33 440. |
| bjorg.egelandsdal@nmbu.no |
Public, Scientific, Principal Investigator
Turku University Hospital, Building 14,
Kiinamyllynkatu 4-8
Turku
20521
Finland
| ORCID ID |
0000-0002-1652-8083 |
|---|---|
| Phone | : +358 02 3130000 |
| milenamonfort@gmail.com |
Public, Scientific
Arboretveien 6
Faculty of Biosciences, NMBU
Ås
1433
Norway
| ORCID ID |
0000-0003-4704-699X |
|---|---|
| Phone | +47 917 33 440. |
| anna.haug@nmbu.no |
Study information
| Study design | Interventional randomized crossover clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Laboratory |
| Study type | Quality of life |
| Participant information sheet | 46295 PIS.pdf |
| Scientific title | Effects of meat and dairy fat and protein on human satiety markers (postprandial part) |
| Study acronym | LIG-IN-two |
| Study hypothesis | To investigate how different animal fat sources (from cheese and pork) affect satiety. |
| Ethics approval(s) |
Approved 26/09/2020, The Norwegian National Research Ethics Committee, Regional Committees for Medical and Health Research Ethics (Kongens gate 14, Oslo, 0153, Norway; +47 (0)23 31 83 00; post@forskningsetikk.no), ref: 139404 |
| Condition | Health/metabolic effects of healthy diets with cheese and pork meat |
| Intervention | The study employs a crossover design with two different breakfast diets. To ensure equal distribution of all test diets, the experiment is structured as a Latin square design. Each diet is tested on separate days with a four-week interval between tests. Participants receive a test meal for breakfast, which includes the test products (cheese and pork sausage) along with bread, tomatoes, and juice. The quantity of the test products in the breakfast is determined by their protein and fat content, with approximately 65-70% of the energy intake (E%) coming from these test products. An Ad libitum buffet is provided, featuring bread slices cut into halves, offering participants half sandwiches. The toppings for these sandwiches are the participants' 2nd and 3rd choices from a pre-determined list presented to them in advance. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Appetite is measured using Ad Libitum buffet, where participants are given 25 quarters of sandwiches with their 2nd and 3rd choice of fillings (cooked ham, cheese, mackerel in tomato sauce, or liver pate) on both experimental days 2. Energy intake is measured using Ad Libitum buffet and Norwegian Directorate of Health/Norwegian Food Safety Authority tool, where participants are given 25 quarters of sandwiches with their 2nd and 3rd choice of fillings (cooked ham, cheese, mackerel in tomato sauce, or liver pate) on both experimental days 3. Prospective food consumption is measured using Visual Analogue Scale (VAS) at fasting, 15’, 30’, 60’, 90’, 120’, 180’, 240’, and after the Ad Libitum buffet 4. Fullness is measured using Visual Analogue Scale (VAS) at fasting, 15’, 30’, 60’, 90’, 120’, 180’, 240’, and after the Ad Libitum buffet 5. Hunger is measured using Visual Analogue Scale (VAS) at fasting, 15’, 30’, 60’, 90’, 120’, 180’, 240’, and after the Ad Libitum buffet 6. Desire to eat is measured using Visual Analogue Scale (VAS) at fasting, 15’, 30’, 60’, 90’, 120’, 180’, 240’, and after the Ad Libitum buffet 7. CCK (pmol/L) is measured using blood tests at seven timepoints during one session 8. Ghrelin (pg/ml) is measured using blood tests at seven timepoints during one session 9. GIP (pg/ml) is measured using blood tests at seven timepoints during one session 10. GLP-1 (pg/ml) is measured using blood tests at seven timepoints during one session 11. Leptin (pg/ml) is measured using blood tests at seven timepoints during one session 12. LDL (mmol/L) is measured using blood tests at seven timepoints during one session 13. HDL (mmol/L) is measured using blood tests at seven timepoints during one session 14. Total cholesterol (mmol/L) is measured using blood tests at seven timepoints during one session 15. Triglycerides (mmol/L) is measured using blood tests at seven timepoints during one session |
| Secondary outcome measures | 1. Ferritin (ng/ml) is measured using blood tests before each of the 2 test days 2. Glucose (mmol/L) is measured using blood tests before each of the 2 test days 3. Insulin (pmol/L) is measured using blood tests before each of the 2 test days 4. Bodyweight is measured using the Tanita TBF-300A Body Composition Analyzer scale before each of the 2 test days 5. Height is measured using a portable stadiometer (Charder HM200P Portstad Portable Stadiometer) at start-up 6. BMI is calculated as body weight (in kg) divided by the height in meters squared before each of the 2 test days 7. Blood pressure is measured using an A&D medical automatic blood pressure monitor (A&D, Tokyo, Japan) before each of the 2 test days 8. Pulse is measured using an A&D medical automatic blood pressure monitor (A&D, Tokyo, Japan) before each of the 2 test days 9. Total protein (g/100 g product) is measured using food product information 10. Amino acid composition (g/100 g product) is measured using food product information 11. Total fat (g/100 g product) is measured using food product information 12. Fatty acid composition (g/100 g product) is measured using food product information |
| Overall study start date | 26/09/2020 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 26 |
| Total final enrolment | 25 |
| Participant inclusion criteria | 1. Use of any medication except birth control pills 2. Not consuming meat and/or dairy products 3. No immediate desires to lose body weight (relevant for the Ad Libitum buffet test) 4. Food allergies 5. Problems with blood withdrawal or low blood pressure |
| Participant exclusion criteria | 1. Use of any medication except birth control pills 2. Not consuming meat and/or dairy products 3. No immediate desires to lose body weight (relevant for the Ad Libitum buffet test) 4. Food allergies 5. Problems with blood withdrawal or low blood pressure |
| Recruitment start date | 01/09/2021 |
| Recruitment end date | 02/11/2021 |
Locations
Countries of recruitment
- Norway
Study participating centre
Ås
1433
Norway
Sponsor information
Government
Stortingsgata 28
Oslo
0161
Norway
| Phone | +47 (0)78 60 60 00 |
|---|---|
| postmottak@landbruksdirektoratet.no | |
| Website | https://www.landbruksdirektoratet.no |
"ROR" |
https://ror.org/03ht51987 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Agriculture and Food, LMD
- Location
- Norway
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | The researchers plan to write one publication in a peer-reviewed journal |
| IPD sharing plan | The raw data as will be stored in the archive set for highest security by Norwegian University of Life Sciences defined by W: Lipidinflammagenes. Raw data are transferred to https://nva.sikt.no/projects?id=https%3A%2F%2Fapi.nva.unit.no%2Fcristin%2Fproject%2F2492957 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. The internal sharing always uses coded and the identification list can only be accessed by project leader in the transition period to ultimate storage at nva.sikt.no |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 28/10/2024 | No | Yes | ||
| Protocol file | 28/10/2024 | No | No | ||
| Statistical Analysis Plan | 28/10/2024 | No | No |
Additional files
Editorial Notes
28/10/2024: Trial's existence confirmed by REK sør-øst.
