Impact of healthy diet and physical activity on metabolic health in men and women: Study Protocol Clinical Trial (SPIRIT Compliant)

Oscar Bergens, Jort Veen, Diego Montiel-Rojas, Peter Edholm, Fawzi Kadi, Andreas Nilsson, Oscar Bergens, Jort Veen, Diego Montiel-Rojas, Peter Edholm, Fawzi Kadi, Andreas Nilsson

Abstract

Introduction: Healthy dietary patterns and physical activity (PA) represent important lifestyle behaviors with considerable potential to influence on age-related metabolic health. Yet, data on the combined effects of these lifestyle behaviors on metabolic health including low-grade systemic inflammation in aging populations remain scarce. Therefore, this protocol describes a randomized controlled trial aiming to examine the impacts of healthy dietary patterns alone or combined with PA on metabolic health in middle-aged and older men and women.

Material and methods: The ORUDIET study is a 3-arm randomized controlled 16-week trial: Healthy Diet (HD), Healthy diet plus PA (HD-PA), and control (CON). The trial is open label, randomized with allocation concealment, parallel groups with passive controls. Participants without overt disease aged between 55 and 70 years, with BMI below 35, a current intake of a maximum of 1 serving of fruit and vegetable per day, and noncompliance to PA guidelines are eligible for inclusion. Participants in HD are instructed to increase fruit and vegetable intake to 5 servings per day (equivalent to 500 g). Participants in HD-PA receive the same dietary intervention as the HD and are additionally instructed to engage in moderate-to-vigorous physical activities for at least 150 minutes per week. The primary study outcomes are changes in metabolic and inflammatory health biomarkers. Secondary outcomes are changes in body composition and perceived health.

Ethics and dissemination: The study protocol has been approved by the ethical review board in Uppsala, Sweden. The results will be published in peer-reviewed journals and disseminated in national and international conferences.

Trial registration number: NCT04062682 Pre-results.

Figures

Figure 1
Figure 1
CONSORT flow diagram of the ORUDIET trial.

References

    1. Beard JR, Officer A, de Carvalho IA, et al. The World report on ageing and health: a policy framework for healthy ageing. Lancet 2016;387:2145–54.
    1. Franceschi C, Garagnani P, Parini P, et al. Inflammaging: a new immune–metabolic viewpoint for age-related diseases. Nat Rev Endocrinol 2018;14:576–90.
    1. Alberti KGM, Zimmet P, Shaw J, et al. Metabolic syndrome: a new world-wide definition. Diabet Med 2006;23:469–80.
    1. World Health Organization. Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series 2003. Geneva: 2016. Available at: . Accessed February 18, 2020.
    1. Hall JN, Moore S, Harper SB, et al. Global variability in fruit and vegetable consumption. Am J Prev Med 2009;36:402–9.
    1. Imamura F, Khatibzadeh S, Fahimi S, et al. Dietary quality among men and women in 187 countries in 1990 and 2010: a systematic assessment. Lancet Glob Health 2015;3:32–42.
    1. Willett W, Rockström J, Loken B, et al. Food in the anthropocene: the EAT–Lancet Commission on healthy diets from sustainable food systems. Lancet 2019;393:447–92.
    1. Root MM, Mcginn MC, Nieman DC, et al. Combined fruit and vegetable intake is correlated with improved inflammatory and oxidant status from a cross-sectional study in a community setting. Nutrients 2012;4:29–41.
    1. Esmaillzadeh A, Tahbaz F, Gaieni I, et al. Cholesterol-lowering effect of concentrated pomegranate juice consumption in Type II Diabetic patients with hyperlipidemia. Int J Vitam Nutr Res 2006;76:147–51.
    1. Holt EM, Steffen LM, Moran A, et al. Fruit and vegetable consumption and its relation to markers of inflammation and oxidative stress in adolescents. J Am Diet Assoc 2009;109:414–21.
    1. Kouki R, Schwab U, Hassinen M, et al. Food consumption, nutrient intake and the risk of having metabolic syndrome: the DR's EXTRA Study. Eur J Clin Nutr 2011;65:368–77.
    1. Baik I, Lee M, Jun N, et al. A healthy dietary pattern consisting of a variety of food choices is inversely associated with the development of metabolic syndrome. Nutr Res Pract 2013;7:233–41.
    1. Nilsson A, Halvardsson P, Kadi F, et al. Adherence to DASH-style dietary pattern impacts on adiponectin and clustered metabolic risk in older women. Nutrients 2019;11:e805.
    1. Freese R, Vaarala O, Turpeinen AM, et al. No difference in platelet activation or inflammation markers after diets rich or poor in vegetables, berries and apple in healthy subjects. Eur J Nutr 2004;43:175–82.
    1. Watzl B, Kulling SE, Möseneder J, et al. A 4-wk intervention with high intake of carotenoid-rich vegetables and fruit reduces plasma C-reactive protein in healthy, nonsmoking men. Am J Clin Nutr 2005;82:1052–8.
    1. Jahns L, Conrad Z, Johnson LK, et al. A diet high in carotenoid-rich vegetables and fruits favorably impacts inflammation status by increasing plasma concentrations of IFN-(2 and decreasing MIP-1( and TNF-( in healthy individuals during a controlled feeding trial. Nutr Res 2018;52:98–104.
    1. Järvi A, Karlström B, Vessby B, et al. Increased intake of fruits and vegetables in overweight subjects: effects on body weight, body composition, metabolic risk factors and dietary intake. Br J Nutr 2016;115:1760–8.
    1. Ali A, Yazaki Y, Njike VY, et al. Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial. Nutr J 2011;10:72.
    1. Vishram JKK, Borglykke A, Andreasen AH, et al. Impact of age and gender on the prevalence and prognostic importance of the metabolic syndrome and its components in Europeans. The MORGAM Prospective Cohort Project. PLoS One 2014;9:e0128848.
    1. Piercy KL, Troiano RP, Ballard RM, et al. The physical activity guidelines for Americans. JAMA 2018;320:2020–8.
    1. Malakou E, Linardakis M, Armstrong MEG, et al. The combined effect of promoting the Mediterranean diet and physical activity on metabolic risk factors in adults: a systematic review and meta-analysis of randomised controlled trials. Nutrients 2018;10:e1577.
    1. Johansson I, Van Guelpen B, Hultdin J, et al. Validity of food frequency questionnaire estimated intakes of folate and other B vitamins in a region without folic acid fortification. Eur J Clin Nutr 2010;64:905–13.
    1. Nilsson A, Wåhlin-Larsson B, Kadi F, et al. Physical activity and not sedentary time per se influences on clustered metabolic risk in elderly community-dwelling women. PLoS One 2017;12:e0175496.
    1. Suvitaival T, Bondia-Pons I, Yetukuri L, et al. Lipidome as a predictive tool in progression to type 2 diabetes in Finnish men. Metabolism 2018;78:1–2.
    1. Kearney JM, McElhone S. Perceived barriers in trying to eat healthier: results of a pan-EU consumer attitudinal survey. Br J Nutr 1999;81:S133–137.
    1. Moschny A, Platen P, Klaaßen-Mielke R, et al. Barriers to physical activity in older adults in Germany: a cross-sectional study. Int J Behav Nutr Phys Act 2011;8:121.
    1. McDonald S, O’Brien N, White M, et al. Changes in physical activity during the retirement transition: a theory-based, qualitative interview study. Int J Behav Nutr Phys Act 2015;12:25.
    1. Liu Z, Ren Z, Zhang J, et al. Role of ROS and nutritional antioxidants in human diseases. Front Physiol 2018;9:477.
    1. Xie Z, Lin H, Fang R, et al. Effects of a fruit-vegetable dietary pattern on oxidative stress and genetic damage in coke oven workers: a cross-sectional study. Environ Health 2015;14:40.

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