Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease
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 supplementat...
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doaj-0271335bc00447458ec5883accd534302021-01-10T12:35:52ZengBMCNutrition Journal1475-28912021-01-0120111010.1186/s12937-020-00660-7Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular diseaseYishu Liu0Nan Li1Ni Yan2Xiong-fei Pan3Qiang Li4Renata Micha5Dariush Mozaffarian6Mark D. Huffman7Yanfang Wang8Bruce Neal9Maoyi Tian10Yi Zhao11Jason H. Y. Wu12The George Institute for Global Health, Faculty of Medicine, University of New South WalesNingxia Medical UniversityNingxia Medical UniversityThe George Institute for Global Health, Faculty of Medicine, University of New South WalesThe George Institute for Global Health, Faculty of Medicine, University of New South WalesFriedman School of Nutrition Science and Policy, Tufts UniversityFriedman School of Nutrition Science and Policy, Tufts UniversityThe George Institute for Global Health, Faculty of Medicine, University of New South WalesPeking University Clinical Research InstituteThe George Institute for Global Health, Faculty of Medicine, University of New South WalesThe George Institute for Global Health, Faculty of Medicine, University of New South WalesNingxia Medical UniversityThe George Institute for Global Health, Faculty of Medicine, University of New South WalesAbstract 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 2019https://doi.org/10.1186/s12937-020-00660-7NutsCardiovascular diseaseRandomized controlled trialPlasma ALA |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Yishu Liu Nan Li Ni Yan Xiong-fei Pan Qiang Li Renata Micha Dariush Mozaffarian Mark D. Huffman Yanfang Wang Bruce Neal Maoyi Tian Yi Zhao Jason H. Y. Wu |
spellingShingle |
Yishu Liu Nan Li Ni Yan Xiong-fei Pan Qiang Li Renata Micha Dariush Mozaffarian Mark D. Huffman Yanfang Wang Bruce Neal Maoyi Tian Yi Zhao Jason H. Y. Wu Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease Nutrition Journal Nuts Cardiovascular disease Randomized controlled trial Plasma ALA |
author_facet |
Yishu Liu Nan Li Ni Yan Xiong-fei Pan Qiang Li Renata Micha Dariush Mozaffarian Mark D. Huffman Yanfang Wang Bruce Neal Maoyi Tian Yi Zhao Jason H. Y. Wu |
author_sort |
Yishu Liu |
title |
Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease |
title_short |
Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease |
title_full |
Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease |
title_fullStr |
Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease |
title_full_unstemmed |
Protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in Chinese adults at high risk of cardiovascular disease |
title_sort |
protocol for a randomized controlled trial to test the acceptability and adherence to 6-months of walnut supplementation in chinese adults at high risk of cardiovascular disease |
publisher |
BMC |
series |
Nutrition Journal |
issn |
1475-2891 |
publishDate |
2021-01-01 |
description |
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 |
topic |
Nuts Cardiovascular disease Randomized controlled trial Plasma ALA |
url |
https://doi.org/10.1186/s12937-020-00660-7 |
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