[MUSIC] Hello, my name is Thomas Meinert Larsen. I'm an associate professor at University of Copenhagen, Department of Nutrition, Exercise, and Sports. I've been conducting nutritional intervention studies for more than ten years. And I'm the leader of the SHOPUS project, a randomized control trial that was carried out to test the health benefits of the New Nordic Diet. The SHOPUS project, which is the abbreviation of Shop-in-OPUS project, I'm going to tell you more about today. Today, I would like to help you to understand how health effects of diet are typically evaluated and why this can sometimes lead to different and often conflicting results. With this in mind, I want you to understand why we think the use of a shop model is a better way to test the health benefits of diet. Then, by explaining the design and results from the SHOPUS project, I hope to teach you how the shop model can be used to improve the validity of the findings of nutritional intervention studies. The usefulness of the shop model may be particularly high, when the items being tested are not isolated ingredients or individual food items. But rather, whole diets that are often complex, and where the whole process of having the diet integrated in the everyday life is probably as important as the diet composition itself. First, I will explain the Shop Model to you, what it is, why we use it, and how we use it. So first, what is the Shop Model? In the shop model, we basically have a normal shop with all sorts of foods available, such as bread, breakfast cereals, vegetable and fruits, meat, fish, and so forth. By using this shop, we are able to provide the participants all food free of charge for the whole study period, such as 26 weeks. Obviously, as we provide all foods for such a long time, one very significant disadvantage of the shop model is the costs. So, why do we use the Shop Model? The scientific community is endorsing a hierarchy among different types of research and available knowledge And this also applies for the results from nutritional research. That we expect to end up as public recommendations for dietary intake for the general population. In this hierarchy, the randomized double blinded control trials are typically consider the study where you obtain the most credible results. But this kind of study is usually also very expensive. And sometimes, such studies may even be impossible to carry out. Despite this hierarchy. And although we have a quite large number of these randomized control trials. The scientific consensus, and dietary recommendations have been very hard to achieve. Partly because the scientific results sometimes seem conflicting. As an example, the results from epidemiological studies often differ from results from the randomized control studies. So, what are these studies actually? To put it simple, the epidemiological studies are those studies where you simply ask people what they do, without controlling what they do, and when you follow them for a certain time period. In the randomised studies, you typically divide the population into two groups by lottery, and then you instruct them what to eat. As an example of the scientific controversy, there are a number of studies from the control studies that reset, suggest that people lose weight when they eat high protein diets. Likewise, there're a number of technological studies saying that you gain weight if you eat high-protein diets. So, it is difficult to make recommendations when we are not sure what to believe. And this controversy is a significant problem when both randomized studies and epidemiological studies makes up a very significant contribution to the totality of scientific information that we have about diet and health. Thus any solid conclusion can be difficult to reach. I do believe, however, that part of the scientific dispute within nutritional research may likely be ascribed to the difficulties in getting to know what study participants were actually eating. In other words, there is typically a lot of uncertainty in the way that we measure what people eat. And that affects our results. As an example, the tools that are typically used to obtain information about diet intake are by using seven-day weighed food records. Or by using food frequency questionnaires. Weighed food record simply mean that participants are instructed to weigh all the foods they eat. A food frequency questionnaire is typically a book with names and pictures of foods. And where you ask the participants to indicate how often they eat these foods. Both of these tools probably do not give an accurate picture of what people eat. Therefore, even though these tools are very much used, they're not universally accepted, and often criticised by experts in the scientific community. Even some researchers believe these tools are a waste of time, as they don't give a true picture of what people eat. So what is then the alternative? Maybe a Shop Model is. Therefore, we have put ourselves the aim of establishing a research setting that would enable us to achieve the maximum control of the food intake by the study participants. Also, in the more long term studies by using the Shop Model. Now that we have the model, how do we use it? It basically worked the same way as ordinary shops that each of you already know. Each study participant visits a shop one to three times weekly to purchase foods free of charge. And all foods in each shopping session are then registered in a computer model, thereby keeping track of the food intake. Furthermore, we can program the computer so that it only allows the purchase session to be completed if certain requirements are fulfilled, such as a particular quantity of carbohydrates, fat or protein. In addition, the participant is instructed to report any foods that are eaten from outside the shop. In this way, we can, in principle, have a full and compete record of what the participant is eating during the study. Even if his, if it's up to half a year. So, a key part of the Shop Model is the computer system, in which all foods are registered by their content of nutrients, such as fats, carbohydrates, protein and so on. But also with vitamins and minerals. Most of this information is obtained from food data bases, but some of the information is often obtained by looking at the nutritional information provided on each food product. As just mentioned, with the computer we can control which type of foods are handed out to the study participants, and the nutritional composition of these foods. We can put up specific requirements for food selection for each of the participants, such as putting up restrictions on the total amount of fat or carbohydrates. But we can also put restrictions on the amount of vegetables and fruits, depending on the scientific aim of the study. In a particular serving session, you simply start by registering who the study participant is. And for how many days he or she will shop for. Then you start entering the foods that a participant has brought to the sales counter. Once products are entered into the program, the program will start to calculate and accumulate nutritional content of these foods. In the shopper's project, the computer was programmed to show the nutritional composition in the active, ongoing purchase situation. But, the computer was also programmed to show the composition of foods that were collected for the last four weeks and also for the totality of the intervention. To help the staff and the participant to get the correct intake of say, protein, not only does the computer calculate protein intake. But the computer also highlights with green or red color if the intake of protein is below or above the recommended intake. There by the staff can easily see which foods are lacking, and which foods are too abundant. And if necessary, he can then instruct the participant to change the selection of food. Sometimes, and particularly in the first shopping sessions, we ask participants to take out a specific food item from the shopping basket. And to replace it into something that fits better into the diet and matches with the targets specified with the program. When the shopping session is complete, the participant gets a receipt listing all the foods that are collected. The slide shows how the computer program works. In the upper row there's information about the specific subject. The subject identity code, how many days he or she has collected food for the start and end date for the actual shopping session, the diet, which is NND or ADD. Run-in period or intervention period, the number of members in the family and the estimated caloric content of the foods that are collected in the active purchase situation. This number can be hidden during the shopping session. In the central part of the screen, each of the food categories are listed. So, in row one, you'll see protein, carbohydrates, added sugar, fiber, total fat, saturated fat. Monosaturated fat, polyunsaturated fat and alcohol. In row two, you see the intake of organic foods of, of Nordic origin, fruits, berries, vegetables, cabbage, root beets, legumes, and whole grains. In row three, you'll see the meat, nuts, fresh herbs, potatoes, wild plants and mushrooms. Seaweed, fish, game, meat and dairy products. For each food category, the total intake of the specific food category is listed. The calculated intake is listed for the current shopping session, for the last four weeks and the total accumulated for the whole intervention period. And the lower right part of the screen, the list of products contained in the current shopping station are listed and can be followed continuously. One of the projects where we have used a Shop Model is the SHOPUS Project. The aim of the SHOPUS Project, which, as I said early on, is a variation of shop in Opus. Was to test whether the New Nordic Diet could improve the health of adult participants that were at risk of developing nutritionally related diseases. We decided to test the New Nordic Diet against the diet that is typically eaten by the average Danish population, which we defined based on dietary surveys done among Danes. This diet we called the Average Danish Diet abbreviated as ADD. Very importantly in SHOPUS, we did not want the participants to count calories. Rather, we wanted them to eat until they felt satiated or satisfied. And this is usually referred to as eating ad libitum. This does, of course, not mean that they should eat whatever they wanted, but more that we instructed them to eat until they felt satiated. And then maybe, it may turn out that one diet is more satiating than the other. And if so, this might provide an extra weight loss and maybe other health benefits. During the intervention, we asked the participants to maintain their habitual, physical activity level. So, that it was not, this would not influence our results. So, the aim was to look at the health effects of following the New Nordic Diet compared to the Average Danish Diet. And we decided to let change in pro, in body weight as a approximation for health benefits. But we also looked at other outcomes, such as waist circumference, plot cholesterol, plot sugar regulation. In addition to these clinical outcomes, we were also very interested to know how well the participants were able to adhere to the diet. And if they dropped out of the study. We chose to include adult participants, both women and men, that were considered at risk for developing lifestyle diseases in our study, presenting with increased waist circumference. And maybe having features of the so-called metabolic syndrome, which is including increased blood sugar, cholesterol, or blood pressure. And, of course, they had to be able to visit the shop to collect the foods. The study was designed as a Six Month Intervention Study where eligible participants were randomized to one of two different diets. Hence, after the screening they were randomized to six months of following one of the two diets. During the six months intervention, they were instructed to collect all foods, free of charge, from the shop, except for alcoholic beverages, coffee and tea. Also they were given individual dietetic counseling by trained dieticians for a total of nine times. And they all received a cooking course in the beginning. In addition, they had to undergo a clinical examination before they started. After 12 weeks of the intervention, and by the end of the six-month intervention period. After the six months intervention, we did not provide them with foods, or with any dietetic guidelines, but we invited them into our department for follow-up visits after another six and 12 months. However, the findings from these follow-up visits I will not cover in my talk today. The two diets, the NND and the ADD, were carefully defined, both in terms of the macronutrient composition but also regarding the type of foods that we decided should constitute the diet. We decided that the NND and the ADD, so the New Nordic Diet and the Average Danish Diet should be relative identical regarding total fat, protein and carbohydrate. But that in particular, the amount of saturated fat and added sugars should be higher in the Average Danish Diet group. Concerning most of the food groups, we aim to have very different intake between diets. But for some foods such as vegetables, berries, and game meat, we strive to achieve a very large difference, such as two, five, or even ten fold differences between the diets. So that the New Nordic Diet was clearly very different from the average Danish diet. Also in order to help the participants to follow the two diets, we developed a number of recipes. So, that they knew how to turn ingredients into delicious meals. Specifically for the New Nordic Diet we developed a number of recipes for each particular season of the year. These recipes were then included in the recipe book for each of the New Nordic Diet, and Average Danish Diet diets. For the New Nordic Diet group, the recipe book contained 180 different recipes. Including recipes for both breakfast, lunch, dinner and snacks. For the New Nordic Diet, the recipes were furthermore divided into four seasons, so, into spring, summer, autumn and winter, thereby helping the participants to prepare meals according to the season. The New Nordic Diet group was also provided a shopping guide, which was a plan describing which products to purchase in order for them to follow a recipe. And to prepare meals at home. The cookbook for the Average Danish Diet group contains somewhat fewer recipes, and the main difference to the New Nordic Diet book was the lack of seasonal variation in the Average Danish Diet cookbook. To give you a real impression of the Shop Model and the way it works, we have prepared this very informative video of how the shopping was carried out. This is one of the participants from the SHOPUS project participating. Please watch this three minute video. Marianne participated in the OPUS project. During the project Marianne went shopping two to three times a week. Marianne starts by registering what food she has left from the last week's shopping. And if she has bought any food elsewhere during the week. By registering her food, the scientists can monitor what the participants are eating. Then Marianne takes a grocery list with the foods she needs to shop today. On the basis of a weekly meal-plan Marianne shops for breakfast, lunch, and dinner. Marianne always begins her shopping in the fruit and vegetable section. This week red cabbage and celeriac are on the menu. To avoid waste of food, some vegetables are kept in smaller portions in a refrigerator, Making it possible to procure the exact amount specified in the recipes. Marianne can get all kinds of food in the shop. For instance, herbs which is one of the foodstuffs that Danes are to eat more often in the New Nordic Diet. Meat of the week is red deer. There's less meat in The New Nordic Diet than in the Danes' average diet, just as more of the meat in the New Nordic Diet is wild game. Besides meat, the main sources of protein in the New Nordic Diet are dairy products, vegetables and leguminous fruits. Marianne needs cherry vinegar. The participants in the project fill their own bottles with cherry vinegar. At the dairy cooler Marianne gets, gets milk, cheese and yoghurt. Split pea soup is a family favorite, so Marianne shops that as well. While shopping, Marianne makes sure to cross out the foodstuffs she has taken on her list. Corn, grain and nuts are also ingredients on her list. Last item on the shopping list is macaroons. When the basket is full, Marianna get her items scanned at the register. It is not the price that is registered, instead it is the foodstuffs' nutritional value. When all foodstuffs are scanned, the computer calculates the amount of proteins, carbohydrates and fat in the purchase, making sure that the participants adhere to the dietary criteria put out. If the distribution does not fit the the dietary criteria of the New Nordic Diet, Marianne picks out additional foodstuffs, in order to get the amount of proteins, carbohydrates and fat right. The shopping is checked by the personnel before she takes the groceries home. [MUSIC]
