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

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

doi:10.1186/s12937-020-00660-7

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

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^*

^*Corresponding author for this work

Preventive Medicine

Research output: Contribution to journal › Article › peer-review

6 Scopus citations

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.

Original language	English (US)
Article number	3
Journal	Nutrition Journal
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s12937-020-00660-7
State	Published - Dec 2021

Funding

M. Huffman has received grant support from the World Heart Federation via Boehringer Ingelheim and Novartis; the American Heart Association, Verily, and AstraZeneca; and the American Medical Association for work unrelated to this paper. He notes institutional relationships through his appointment at The George Institute with AbbVie, Actelion, and Janssen. We gratefully acknowledge the contribution of all the village doctors and participants in the NUTS study for their diligence and cooperation. M. Huffman has received grant support from the World Heart Federation via Boehringer Ingelheim and Novartis; the American Heart Association, Verily, and AstraZeneca; and the American Medical Association for work unrelated to this paper. He notes institutional relationships through his appointment at The George Institute with AbbVie, Actelion, and Janssen. The study was supported by a National Health and Medical Research Council of Australia (NHMRC) Program Grant (APP1149987). The authors are solely responsible for the design and conduct of this study, all study analyses, and the drafting and editing of the manuscript and its contents.

Keywords

Cardiovascular disease
Nuts
Plasma ALA
Randomized controlled trial

ASJC Scopus subject areas

Medicine (miscellaneous)
Nutrition and Dietetics

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1186/s12937-020-00660-7

Cite this

Liu, Y., Li, N., Yan, N., Pan, X. F., Li, Q., Micha, R., Mozaffarian, D., Huffman, M. D., Wang, Y., Neal, B., Tian, M., Zhao, Y., & Wu, J. H. Y. (2021). 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, 20(1), Article 3. https://doi.org/10.1186/s12937-020-00660-7

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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",

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.",

keywords = "Cardiovascular disease, Nuts, Plasma ALA, Randomized controlled trial",

author = "Yishu Liu and Nan Li and Ni Yan and Pan, \{Xiong fei\} and Qiang Li and Renata Micha and Dariush Mozaffarian and Huffman, \{Mark D.\} and Yanfang Wang and Bruce Neal and Maoyi Tian and Yi Zhao and Wu, \{Jason H.Y.\}",

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doi = "10.1186/s12937-020-00660-7",

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Liu, Y, Li, N, Yan, N, Pan, XF, Li, Q, Micha, R, Mozaffarian, D, Huffman, MD, Wang, Y, Neal, B, Tian, M, Zhao, Y & Wu, JHY 2021, '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, vol. 20, no. 1, 3. https://doi.org/10.1186/s12937-020-00660-7

TY - JOUR

T1 - 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

AU - Liu, Yishu

AU - Li, Nan

AU - Yan, Ni

AU - Pan, Xiong fei

AU - Li, Qiang

AU - Micha, Renata

AU - Mozaffarian, Dariush

AU - Huffman, Mark D.

AU - Wang, Yanfang

AU - Neal, Bruce

AU - Tian, Maoyi

AU - Zhao, Yi

AU - Wu, Jason H.Y.

PY - 2021/12

Y1 - 2021/12

N2 - 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.

AB - 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.

KW - Cardiovascular disease

KW - Nuts

KW - Plasma ALA

KW - Randomized controlled trial

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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

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UN SDGs

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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

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Funding

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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Additional file 1 of 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

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