A comparison of the "inverted food pyramid" and the "conventional" food pyramid" for body weight management

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2 A comparison of the "inverted food pyramid" and the "conventional" food pyramid" for body weight management - A three year randomized dietary intervention trial Ph.D. Thesis by Anette Due Department of Human Nutrition Centre for Advanced Food studies Faculty of Life Sciences University of Copenhagen

3 Title: A comparison of the "inverted food pyramid" and the "conventional food pyramid" for body weight management - A three year randomized dietary intervention trial Danish title: Sammenligning af den omvendte kostpyramide og den traditionelle kostpyramide på kropsvægt - 3 års randomiseret kostintervention Ph.D. Thesis by M.Sc. Anette Due Public defence: The public defence will take place on May 9 th 2008 at 13:30 h in Auditorium 3-14, Thorvaldsensvej 40, Faculty of Life Sciences, University of Copenhagen, Denmark Supervisor: Professor Dr. Med. Arne Astrup Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Denmark Opponents: Professor Lars Ove Dragsted Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Denmark Professor Dr. Med. Steen Madsbad Department of Endocrinology, Hvidovre Hospital, Denmark M.Sc. Ph.D. Inge Tetens Department of Nutrition, Danish Institute for Food and Veterinary Research, Denmark Department of Human Nutrition Centre for Advanced Food studies Faculty of Life Sciences University of Copenhagen Rolighedsvej 30 DK-1958 Frederiksberg C Denmark Phone: Fax: ihe@life.ku.dk ISBN Printed by Ekspressen Tryk og Kopicenter ApS, Rødovre, Denmark,

4 PREFACE & ACKNOWLEDGEMENT The investigations presented in this PhD thesis are based on the three year dietary intervention trial MUFObes (Mono Unsaturated Fatty acids in Obesity) conducted from January 2004 to June 2007 at the Department of Human Nutrition, Centre for Advanced Food studies, Faculty of Life Sciences, University of Copenhagen (the Royal Veteranary and Agricultural University until January 2007). The investigations were undertaken in collaboration with Biocentrum DTU, Technical University of Denmark, Denmark, Department of Endocrinology and Metabolism, Århus University Hospital, Århus, Denmark, and Department of Clinical Chemistry, Copenhagen University Hospital, Gentofte, Denmark. This research was supported by: H.A. Foundation, The Danish Heart Association, The Danish Diabetes Association, Centre for Advanced Food Research, The state Research Councils, The Danish Pork Council foundations, associations, and research councils: Foods in the supermarket and low calorie diets were sponsored by: Nutrillett, H.A. Foundation, KGT/DEG, The Danish Pork council, Danisco, FDB, Arla Foods, The Danish Heart Association, LMC Rådighedsfond. Food sponsors: 3-stjernet, Aarhus United, Allara, Ardo/Frigodan, Beauvais, Bæchs Conditori, Bähncke, Cadiso, Cerealia, Daloon, Danisco, FDB, Flensted, Frisko, G-kartofler, Gamba Food, Jan Import, Kellogg s, Kims, Kraft Foods, Kryta, Københavns Engros Grønttorv, Kødbranchens Fællesråd, LCH catering, Lykkeberg, Malaco Leaf, Nutana, Nutrillett, Odense Marcipan, Polar Is, Puratos, Rose Poultry, Rynkeby, Saeby, Santa Maria, Schulstad, Svansø, Sønderjysk Kål, Tholstrup Cheese, Toms, Tulip, Unilever, Urtekram and Wasa: This thesis is based on the following three publications/manuscripts, which are reffered to as Paper I, Paper II, and Paper III, respectively. Unpublished data are also presented. Paper I Anette Due, Thomas M Larsen, Huiling Mu, Kjeld Hermansen, Steen Stender and Arne Astrup Comparison of three ad libitum diets for weight loss maintenance, risk for CVD and diabetes: A 6 month randomised, controlled trial. Submitted to American Journal of Clinical Nutrition Paper II Anette Due, Thomas M Larsen, Huiling Mu, Kjeld Hermansen, Steen Stender, Søren Toubro, David B Allison and Arne Astrup. The optimal diet to prevent weight regain. A randomized 18 month trial. Submitted to Archives of Internal Medicine Paper III Anette Due, Thomas M Larsen, Kjeld Hermansen, Steen Stender, Jens J Holst, Søren Toubro, Torben Martinussen, and Arne Astrup. Comparison of the effects on insulin resistance and glucose tolerance of 6-mo high-monounsaturated-fat, low-fat, and control diets. American Journal of Clinical Nutrition 2008;87:

5 The accomplishment of the MUFObes trial and scientific papers had never been possible without the encouragement and support from several people. I hereby take the opportunity to thank the following: My supervisor, Arne Astrup, for giving me the opportunity to work within the field of obesity and for sharing his profound knowledge in this very exciting field, and not least for always being available online. My thanks too, to Henrik Sillesen for acting as supersisor. I would also like to adresse my particular gratitude to Thomas Meinert Larsen, for sharing his great enthuasim and engagement in the project, and his skilled input through out the process, though not being my formal supervisor. The MUFObes project team: The dieticians, Ulla Pedersen, Annette Vedelsbang, Martin Kreutzer, Susanne Jensen, Birthe Nielsen for their excellent assistance and hard work in encouraging the subjects to follow the respective diets and to stay within the project. The medical laboratory technicians, Helle Reinikka Christensen, Kirsten Bryde Rasmussen, Vivian Anker and Inge Timmermann for taking blood samples and for performing laboratical analyses. Martin Kreutzer and John Lind for help in performing the DXA scans. Charlotte Kostecki, Karina Graff Rossen, Kira Hamann, Berit Hoielt and Yvonne Rasmussen from the kitchen for their skilled assistance during the practical part of the experimental study and for taking great part in the hard work in the supermarket, and also all the master students and other volunteers who helped in running the supermarket. The secretariat is thanked for their technical support and assistance and especially Geske Louise Rune for her always good spirits and Christina Cuthbertson for her good advice and in assistance in proof reading. The project partners, Steen Stender (Copenhagen University Hospital, Gentofte), Kjed Hermansen (Århus University Hospital), Huiling Mu (Biocentrum DTU), the sponsors of the project and of the foods in the supermarket and not least all the participants of the trial, without whom the projects had not been possible. My present and former colleagues at the Department of Human Nutrition, particularly the younger scientific staff and my roommates for good scientific and less scientific discussions. Friends and family for their ongoing support and for reminding me what is most important in life. Anette Due, January

6 CONTENT PREFACE & ACKNOWLEDGEMENT... 3 SUMMERY... 7 DANSK RESUMÉ ABBREVATIONS LIST OF TABLES AND FIGURES BACKGROUND Obesity and associated risk factors Prevalence of overweight and obesity Dietary composition Energy balance and appetite Dietary fat Low-fat diets Moderate fat diet - Mediterranean diet Type of dietary fat Dietary carbohydrate Simple versus complex carbohydrate Fibre & whole grain Glycemic index Dietary protein Dietary guidelines & food pyramids Dietary guidelines in Denmark and USA The conventional food pyramids The new Healthy Eating Pyramid HYPOTHESIS & AIM Hypothesis & aim Overview of study design and study outcomes METHODS Participants and recruitment Inclusion criteria: Exclusion criteria: Study flow Time flow - 5 phases Dietary intervention & dietary counselling Intervention diets Dietary instruction and physical activity Supermarket model Supermarket facilities Computer system Shopping session Assessments of dietary compliance Fat biopsies Questionnaires on dietary adherence Assessment of anthropometry Body weight Body composition Assessment of risk factors for T2D and CVD Oral Glucose tolerance test (OGTT) Biochemical measurements Power calculation Statistical analysis Ethics

7 4. RESULTS Participants & Attrition rate Participant Characteristics Completion of the trial Dietary intake Standardization period Supermarket period Instruction period Body weight Weight loss period Weight loss maintenance period Follow-up period Body composition Weight loss maintenance period Cardiovascular & diabetes risk factors Fasting blood samples Glucose tolerance Insulin response and change in body weight and body fat Dietary factors and changes in outcome Dietary compliance supermarket period Fatty acid composition in fat tissue Dietary compliance instruction period Fatty acid composition in fat tissue Questionnaires on self-reported dietary adherence Specific dietary principles within each group DISCUSSION The effect of diet composition Weight loss maintenance and body composition Body weight versus body fat Risk factors for T2D and CVD Glucose metabolism Blood lipid profile The effect of dietary components Fibre Energy density Type of dietary fat Methodological considerations Dietary compliance Fat biopsies Questionnaires on dietary adherence Attrition rate Design of study Supermarket model and the ad libitum principle Attention to study groups Length of intervention Completer vs Intention-To-Treat analysis CONCLUSION & PERSPECTIVES REFERENCE LIST APPENDIX: PAPER I - III

8 SUMMERY Overweight and obesity is becoming a global epidemic and the associated health consequences are increased risk of premature mortality and morbidity from e.g. non-insulin-dependent diabetes mellitus (T2D) and cardiovascular disease (CVD). Although the aetiology of obesity is complex and multifactorial, the obese state can only be reached by a long-term positive energy balance with energy intake being higher than energy expenditure. Dietary composition affects appetite and energy intake and is believed to play an important role in weight management. One major question that needs to be answered is What dietary composition is the most beneficial in maintaining a healthy body weight and preventing the development of diet related diseases in obesity prone individuals? The official dietary guidelines have primarily aimed at reducing the total fat in the diet to less than 30% of calories and there is good evidence from meta-analyses that this low-fat diet can prevent weight gain in normal weight individuals, induce a small but clinically relevant weight loss in overweight individuals, and also reduce the risk of T2D and CVD. However, the traditional dietary recommendation has been challenged by the epidemiologist Walter Willett, Harvard Medical School in Boston, and colleagues arguing that it is not the amount, but the type of fat and carbohydrate that is important in weight management and prevention of chronic disease. Based on mainly large-scale observational studies ( Nurses Health Study ) the new Healthy Eating Pyramid was promoted. This pyramid is high in vegetable oil, whole grains foods, nuts, legumes, fruits and vegetables, and low in carbohydrates with high glycemic index (GI), among these white rice, white bread, potatoes and pasta, and also low in meat and dairy products. The main feature of this new Healthy Eating Pyramid is that dietary fat in the form of plant oils is displayed at the bottom of the pyramid and more traditional basic foods like white rice, white bread, potatoes and pasta in the top. This reversion is regarded as the most controversial part of Willett s recommendations and the reason why the pyramid also is referred to the inverted dietary pyramid. These guidelines resembles the Mediterranean style Diet that has been found beneficial for some of the traditional risk factors for T2D and CVD. However, there is also growing concern that the increased total fat content will lead to weight gain and increased risk of obesity, and secondary to this, T2D and CVD. To test this hypothesis the largest and longest dietary intervention trial in Denmark MUFObes (Mono Unsaturated Fatty acids in Obesity) was carried out at the Department of Human Nutrition, Copenhagen University. The trial was a parallel, randomized dietary intervention conducted from January 2004 to June The aim was to compare three different ad libitum diets, 1. MUFA: Moderate-fat (40 E%) with 20E% monounsaturated-fatty-acids and low in GI [n=54], 2. LF: Low Fat (25 E%) and medium in GI [n=51] or 3. CTR ConTRol (35 E% fat) with 15 E% saturated fat 7

9 and high in GI [n=26] all with similar protein content. All participants were provided foods free of charge from a purpose-built supermarket. Comparisons were done after 6-months strictly controlled dietary intervention (100% food supply), subsequently 12 months less controlled intervention (20% food supply) and another 18 months follow-up in overweight and obese subjects following an initial 8 % weight loss. Main end-points were the dietary effect on maintenance of weight loss, changes in body composition, changes in risk factors of T2D and CVD, attrition rate and dietary compliance. The present trial demonstrated after 6 months intervention that the LF diet was significantly more superior in prevention of body fat regain and exerted a significantly greater increase in lean mass compared to the CTR diet. Likewise, the MUFA diet was significantly better in prevention of fat regain compared to the CTR diet. Though, no significant differences were displayed between the two primary intervention groups (MUFA and LF) (Paper I). None of the three tested ad libitum diets were found significantly superior in preventing weight regain, either after 6 or 18 months intervention, suggesting that the amount and type of fat and carbohydrate in the diet may not be particularly important for weight management (Paper I+II). However, the MUFA diet seemed to improve the glucose metabolism compared to the CTR diet and may also be more favourable than the LF diet after 6 months (Paper I+III). These favourable effects were not sustained after 18 months, most probably due to the lower sample size and perhaps to decreased dietary compliance in the less intensive intervention period (Paper II). The lack of dietary effect on risk for CVD may be due to the normal blood lipids of our participants, and perhaps due to the antecedent weight loss, or to other unknown dietary components. A good compliance to the dietary fat intake was achieved, as witnessed by measured changes in fatty acids in the fat biopsies (Paper I+II), and good compliance in general to the respective diets was demonstrated by questionnaires completed by the participants and by assessment by the dietician (Paper II). A high intake of both monounsaturated fat and polyunsaturated fat, and fibre seemed to exert a potential favourable effect in prevention of weight and body fat regain, whereas a greater intake of saturated fat and indirectly of sugar predicted the opposite. The better the subjects in the LF and MUFA groups reported to comply with the diets, the less weight regain was seen. Though the questionnaires were subjective, they seem to have been reliable (Paper II). A greater drop-out rate was found in the MUFA group both after 6 and 18 months intervention (Paper I+II+III). The reason for this greater drop-out remained unexplained, but it could be due to the low acceptance of this diet in our Scandinavian population, where a Mediterranean style diet is not common. Several subjects in this group reported difficulties in adapting to the diet, primarily due to the high intake of vegetable oil and legumes. 8

10 The results of the MUFObes trial resemble other similar trials but not all, probably due to methodological differences. Among these differences are type and amount of attention given to the respective groups, length of intervention, statistical analyses and the health status of participants. These differences are important to take into consideration when comparing the present trial with other trials. In conclusion, both the official recommended low-fat diet and the diet according to the new Healthy Eating Pyramid were significantly more superior in prevention of body fat regain subsequent an initial weight loss compared to the Western diet. However, no dietary effect was seen in preventing weight regain, suggesting that the amount and type of fat and carbohydrate in the diet may not be particularly important for weight management. The new Healthy Eating Pyramid seemed to improve the glucose metabolism compared to a normal Western diet and might also be more favourable compared to the official recommended diet. However, this diet similar to the Mediterranean diet produced a greater drop out most likely due to a low acceptance of this diet in our Scandinavian population. 9

11 DANSK RESUMÉ Overvægt og fedme er ved at udvikle sig til en global epidemi og de associerede helbredskonsekvenser omfatter øget risiko for sygelighed og tidlig død fra f.eks. type 2 diabetes (T2D) og hjerte-kar-sygdom (HKS). På trods af årsagen til fedme er kompleks og multifaktoriel, kan fedme kun opnås ved positiv energibalance over lang tid, hvor energiindtaget er større end energiforbruget. Kostsammensætningen påvirker appetit og energibalance og menes at spille en vigtig rolle ved regulering af kropsvægt. Ét centralt spørgsmål er således Hvilken kostsammensætning er mest fordelagtig ved vedligeholdelse af en sund kropsvægt og forebyggelse af kostrelaterede sygdomme hos overvægtige, som er tilbøjelige til at blive overvægtige? De officielle kostanbefalinger har primært fokuseret på at reducere det totale fedtindtag i kosten til mindre end 30 % af kalorierne (E%) og flere meta-analyser har vist at denne fedt-reducerede kost kan forebygge vægtøgning hos normalvægtige, medføre et mindre men klinisk relevant vægttab hos overvægtige samt reducere risikoen for T2D og HKS. Imidlertid er de traditionelle kostanbefalinger blevet udfordret af epidemiolog Walter Willett, Harvard Medical School in Boston og kolleger, som ikke mener det er mængden, men typen af fedt og kulhydrat, som har betydning for regulering af kropsvægt og kroniske sygdomme. Baseret på store observationelle studier (bl.a. Nurses Health Study ) er en ny kostpyramide the new Healthy Eating Pyramid blevet fremført. Denne kostpyramide er rig på vegetabilske olier, fuldkornsprodukter, nødder, bælgfrugter, frugt og grønt, og samtidig fattig på kulhydrater med højt glykemisk indeks (GI), herunder hvide ris, hvidt brød, kartofler og pasta samt fattig på rødt kød og mælkeprodukter. Hovedtrækkene ved the new Healthy Eating Pyramid er at planteolier er placeret i bunden af pyramiden, mens de mere traditionelle basis-fødevarer (hvide ris, hvidt brød og kartofler) er placeret i toppen af pyramiden. Denne ændring betragtes som den mest kontroversielle del af Willett s kostpyramide og er årsagen til den omtales som den omvendte kostpyramide. Willett s kostanbefalinger ligner middelhavskosten som menes at være favorabel for nogle traditionelle risikofaktorer for T2D og HKS, men der er imidlertid også en stor bekymring for at stigningen i det totale fedtindtag vil medføre vægtøgning og derved øget risiko for fedme og efterfølgende T2D og HKS. For at teste denne hypotese, blev det største og længste kostinterventionsstudie i Danmark MUFObes (Mono Unsaturated Fatty acids in Obesity) igangsat på Institut for Human Ernæring, Københavns Universitet. Studiet var et parallelt, randomiseret koststudie, som blev udført fra januar 2004 til juni Formålet var at sammenligne tre forskellige ad libitum kosttyper, 1. MUFA: Moderat-fedt (40 E%) med 20 E% monoumættet-fedt og lav GI [n=54], 2. LF: Lav Fedt (25 E%) og moderat i GI [n=51] eller 3. CTR: ConTRol (35 E% fat) med 15 E% mættet fedt og høj i GI [n=26], med 15 protein E% i alle kosttyper. Der blev til formålet indrettet en butik, hvor alle 10

12 forsøgsdeltagere gratis handlede deres fødevarer. Sammenligningerne blev foretaget efter 6 mdr. strengt kontrolleret kost intervention (100 % udleveret fra butik), efterfølgende 12 mdr. mindre kontrolleret intervention (20 % udleveret fra butik) og 18 mdr. opfølgning hos overvægtige og fede mennesker efter et forudgående vægttab på 8 %. Effekt-parametrene var kostens betydning for vedligehold af vægttab og ændringer i kropssammensætning, ændringer i risko-markører for T2D og HKS, samt frafald og overensstemmelse mellem det forventede og faktiske kostindtag (kostkompliance). Efter 6 mdrs. intervention viste studiet at LF kosten var signifikant bedre til at forebygge stigningen i fedtmasse og medførte en signifikant større stigning i fedtfri masse i forhold til CTR kosten. Ligeledes viste MUFA kosten at medføre en signifikant mindre stigning i fedtmasse sammenlignet med CTR kosten. Der var dog ingen signifikant forskel på de to primære interventions grupper (MUFA og LF) (Artikel I). Ingen af de tre testede ad libitum kosttyper viste sig at være signifikant forskellige med hensyn til vægtøgning, hverken efter 6 eller 18 mdrs. intervention eller efter opfølgningsperioden, hvilket kunne betyde at mængden og typen af fedt og kulhydrater ikke har den helt store effekt på kropsvægt (Artikel I+II). Imidlertid viste studiet at glukoseomsætningen blev forbedret på MUFA kosten sammenlignet med CTR kosten og muligvis også i forhold til LF efter 6 mdr. (Artikel I+III). Disse forbedringer var ikke længere gældende efter 18 mdrs. intervention, hvilket formentlig skyldes en lavere populationsstørrelse grundet frafald og muligvis lavere efterlevelsesgrad af kosten i den mindre kontrollerede periode (Artikel II). Den manglende effekt på risiko-markører for HKS kunne skyldes deltagernes normale koncentration af fedtstoffer i blodet og evt. det forudgående vægttab, eller andre ikke identificerede kostkomponenter. Der var en god overensstemmelse mellem det forventede indtag af fedt fra kosten og ændringer i fedtsyresammensætningen i fedtbiopsierne, hvilket er et udtryk for en relativ god kost-kompliance (Artikel I+II). Ydermere fandtes en generel god overensstemmelse mellem den forventede kostsammensætning i de respektive grupper og spørgeskemaer om efterlevelsesgrad både udfyldt af forsøgsdeltagerne og af diætisten (Artikel II). Et højt indtag af både monoumættet fedt og polyumættet fedt samt fibre viste at medføre en favorabel indvirkning på forebyggelse af øgning i vægt og kropsfedt, mens et højere indtag af mættet fedt og indirekte også sukker forudsagde det modsatte. Desto højere kost-kompliance forsøgsdeltagerne i MUFA og LF grupperne afrapporterede, desto lavere vægtøgning blev fundet og trods spørgeskemaerne var subjektive vurderedes de at være pålidelige (Artikel II). Et signifikant større frafald blev registreret i MUFA gruppen efter 6 og 18 mdr. intervention (Artikel I+II+III), hvilket formentlig skyldes at denne middelhavslignende kost er sjælden og mindre accepteret i denne skandinaviske population. Flere forsøgsdeltagere afrapporterede problemer med at vænne sig til kosten især på grund af det høje indtag af vegetabilske olier og bælgfrugter. 11

13 Resultaterne fra dette MUFObes studie stemmer overens med flere lignende studier, men ikke alle og forskelle i studiernes metode menes at være den primære årsag hertil. Metodiske overvejelser, herunder type og antal af opmærksomhed givet til de respektive grupper, længden af interventionen, valg af statistiske analyser, og om forsøgedeltagerne er syge eller raske er vigtige at tage højde for ved sammenligning af andre studier. Det blev konkluderet, at både de officielle kostanbefalinger og Willett s kostanbefalinger var signifikant bedre ved forebyggelse af øgning i kropsfedt efter et forudgående vægttab sammenlignet med en gennemsnitlig vestlig kost. Der var imidlertid ingen forskel på vægtudvikling på de tre ad libitum kosttyper, hvilket kunne betyde at mængden og typen af fedt og kulhydrater ikke har den helt store effekt på kropsvægt. Willett s kostanbefalinger forbedrede glukoseomsætningen sammenlignet med den vestlige kost og muligvis også i forhold til de officielle kostanbefalinger. Derimod var der et større frafald i netop denne gruppe, formentlig grundet denne middelhavslignende kost er sjælden og mindre accepteret i denne skandinaviske population. 12

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