Yishu Liu1,2, Nan Li3, Ni Yan3, Xiong-Fei Pan1, Qiang Li1, Renata Micha4, Dariush Mozaffarian4, Mark D Huffman1,5, Yanfang Wang6, Bruce Neal1,7,8, Maoyi Tian1,2, Yi Zhao9, Jason H Y Wu10. 1. The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia. 2. The George Institute for Global Health at Peking University Health Science Center, Beijing, China. 3. Ningxia Medical University, Yinchuan, China. 4. Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, USA. 5. Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. 6. Peking University Clinical Research Institute, Beijing, China. 7. School of Public Health, Imperial College London, London, UK. 8. Sydney School of Public Health, University of Sydney, Sydney, Australia. 9. Ningxia Medical University, Yinchuan, China. zhaoyi751114@gmail.com. 10. The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia. jwu1@georgeinstitute.org.au.
Abstract
BACKGROUND: Consumption of nuts improves cardio-metabolic risk factors in clinical trials and relates to lower risk of cardiovascular disease (CVD) in prospective observational studies. However, there has not been an adequately powered randomized controlled trial to test if nuts supplementation actually reduces incident CVD. In order to establish the feasibility of such a trial, the current study aimed to assess the acceptability and adherence to long-term nut supplementation amongst individuals at high CVD risk in China. METHODS: This protocol described a 6-month trial performed in Ningxia Province in China among participants with a history of CVD or older age (female ≥65 years, male ≥60 years) with multiple CVD risk factors. Participants were randomized to control (received non-edible gift), low dose walnut (30 g/d), or high dose walnut (60 g/d) groups in a 1:1:1 ratio. Walnuts were provided at no cost to participants and could be consumed according to personal preferences. Follow-up visits were scheduled at 2 weeks, 3 months and 6 months. The primary outcome was fasting plasma alpha linolenic acid (ALA) levels used as an indicator of walnut consumption. Secondary outcomes included self-reported walnut intake from the 24 h dietary recalls. The target sample size of 210 provided 90% statistical power with two-sided alpha of 0.05 to detect a mean difference of 0.12% (as percent of total fatty acid) in plasma ALA between randomized groups. RESULTS:Two hundred and ten participants were recruited and randomized during October 2019. Mean age of participants was 65 years (SD = 7.3), 47% were females, and 94% had a history of CVD at baseline. Across the three study groups, participants had similar baseline demographic and clinical characteristics. DISCUSSION: This trial will quantify acceptability and adherence to long-term walnut supplementation in a Chinese population at high risk of CVD. The findings will support the design of a future large trial to test the effect of walnut supplementation for CVD prevention. TRIAL REGISTRATION: NCT04037943 Protocol version: v3.0 August 14 2019.
RCT Entities:
BACKGROUND: Consumption of nuts improves cardio-metabolic risk factors in clinical trials and relates to lower risk of cardiovascular disease (CVD) in prospective observational studies. However, there has not been an adequately powered randomized controlled trial to test if nuts supplementation actually reduces incident CVD. In order to establish the feasibility of such a trial, the current study aimed to assess the acceptability and adherence to long-term nut supplementation amongst individuals at high CVD risk in China. METHODS: This protocol described a 6-month trial performed in Ningxia Province in China among participants with a history of CVD or older age (female ≥65 years, male ≥60 years) with multiple CVD risk factors. Participants were randomized to control (received non-edible gift), low dose walnut (30 g/d), or high dose walnut (60 g/d) groups in a 1:1:1 ratio. Walnuts were provided at no cost to participants and could be consumed according to personal preferences. Follow-up visits were scheduled at 2 weeks, 3 months and 6 months. The primary outcome was fasting plasma alpha linolenic acid (ALA) levels used as an indicator of walnut consumption. Secondary outcomes included self-reported walnut intake from the 24 h dietary recalls. The target sample size of 210 provided 90% statistical power with two-sided alpha of 0.05 to detect a mean difference of 0.12% (as percent of total fatty acid) in plasma ALA between randomized groups. RESULTS: Two hundred and ten participants were recruited and randomized during October 2019. Mean age of participants was 65 years (SD = 7.3), 47% were females, and 94% had a history of CVD at baseline. Across the three study groups, participants had similar baseline demographic and clinical characteristics. DISCUSSION: This trial will quantify acceptability and adherence to long-term walnut supplementation in a Chinese population at high risk of CVD. The findings will support the design of a future large trial to test the effect of walnut supplementation for CVD prevention. TRIAL REGISTRATION: NCT04037943 Protocol version: v3.0 August 14 2019.
Authors: Liana C Del Gobbo; Michael C Falk; Robin Feldman; Kara Lewis; Dariush Mozaffarian Journal: Am J Clin Nutr Date: 2015-11-11 Impact factor: 7.045
Authors: Ramón Estruch; Emilio Ros; Jordi Salas-Salvadó; Maria-Isabel Covas; Dolores Corella; Fernando Arós; Enrique Gómez-Gracia; Valentina Ruiz-Gutiérrez; Miquel Fiol; José Lapetra; Rosa M Lamuela-Raventos; Lluís Serra-Majem; Xavier Pintó; Josep Basora; Miguel A Muñoz; José V Sorlí; J Alfredo Martínez; Montserrat Fitó; Alfredo Gea; Miguel A Hernán; Miguel A Martínez-González Journal: N Engl J Med Date: 2018-06-13 Impact factor: 91.245
Authors: Dagfinn Aune; NaNa Keum; Edward Giovannucci; Lars T Fadnes; Paolo Boffetta; Darren C Greenwood; Serena Tonstad; Lars J Vatten; Elio Riboli; Teresa Norat Journal: BMC Med Date: 2016-12-05 Impact factor: 8.775
Authors: Effie Viguiliouk; Cyril W C Kendall; Sonia Blanco Mejia; Adrian I Cozma; Vanessa Ha; Arash Mirrahimi; Viranda H Jayalath; Livia S A Augustin; Laura Chiavaroli; Lawrence A Leiter; Russell J de Souza; David J A Jenkins; John L Sievenpiper Journal: PLoS One Date: 2014-07-30 Impact factor: 3.240