Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored intervention

BackgroundIncreased post-prandial glycemic excursions contribute to the development of diabetes and have been observed in women with recent gestational diabetes mellitus (GDM) and with normal glucose tolerance at post-partum. As a convenient meal replacement, low-GI biscuits are helpful for improvin...

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Main Authors: Chunrong Li, Yan Gao, Tongyong Luo, Shiji Qin, Xue Yao, Ye Wen, Xue Wang, Jing Zhang, Qiong Zhong, Hao Shi, Jing Liu
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-03-01
Series:Frontiers in Nutrition
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fnut.2023.1122102/full
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author Chunrong Li
Chunrong Li
Yan Gao
Tongyong Luo
Shiji Qin
Xue Yao
Ye Wen
Xue Wang
Jing Zhang
Qiong Zhong
Hao Shi
Jing Liu
author_facet Chunrong Li
Chunrong Li
Yan Gao
Tongyong Luo
Shiji Qin
Xue Yao
Ye Wen
Xue Wang
Jing Zhang
Qiong Zhong
Hao Shi
Jing Liu
author_sort Chunrong Li
collection DOAJ
description BackgroundIncreased post-prandial glycemic excursions contribute to the development of diabetes and have been observed in women with recent gestational diabetes mellitus (GDM) and with normal glucose tolerance at post-partum. As a convenient meal replacement, low-GI biscuits are helpful for improving glycemic excursions in patients with type 2 diabetes. However, it is unknown whether low-GI biscuits as pre-loads or mid-meal snacks have a better effect in diminishing post-prandial glycemic excursions from the individual level in women with recent GDM. Therefore, the aim of this trial is to tailor a better dietary strategy utilizing low-GI biscuits (Fitmeal) to improve post-prandial glycemic excursions through within-subject comparison in such a population and observe the long-term effect of a tailored dietary approach in glycemic control.MethodsWe have designed a two-phase trial including a randomized, crossover, non-blinded trial in the first phase, followed by a 4-week tailored intervention in the second phase. A total of 52 post-partum women with recent GDM will be allocated into four meal plans: (1) Fitmeal pre-load 30 min before standard lunch meal (P+L), (2) Fitmeal as a mid-meal snack 2 h before standard lunch meal (S+L), (3) isocaloric standard control with co-ingestion of Fitmeal and standard lunch meal (CL) at the same time, and (4) placebo control with 200 ml of water taken 30 min before standard lunch meal (W + L), on four consecutive days. Acute post-prandial glycemic response (PGR) measured by continuous glucose monitoring (CGM) will be compared among the four meals. In the second phase, all participants will receive a 4-week tailored intervention using Fitmeal as pre-loads or mid-meal snacks based on within-subject PGR results from the first phase. Glycemic metrics, dietary behaviors, and psychosocial factors (e.g., quality of life, self-efficacy, perceived stress, and depression) will be examined at baseline and end-point.DiscussionThis trial is expected to optimize the use of low-GI biscuits as pre-loads or mid-meal snacks in improving individual post-prandial glycemic excursions among women with recent GDM. Furthermore, the findings of this study will provide novel information on how to deliver an effective dietary intervention at the individual level and guide future clinical practice of medical nutrition therapy for diabetes prevention.Trial registration numberChinese clinical trial registry, ChiCTR2200060923.
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spelling doaj.art-817dea640ebe4845aa8352c41bf81af92023-03-23T05:49:55ZengFrontiers Media S.A.Frontiers in Nutrition2296-861X2023-03-011010.3389/fnut.2023.11221021122102Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored interventionChunrong Li0Chunrong Li1Yan Gao2Tongyong Luo3Shiji Qin4Xue Yao5Ye Wen6Xue Wang7Jing Zhang8Qiong Zhong9Hao Shi10Jing Liu11Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, ChinaWomen Health Department, Chengdu Jintang District Maternal and Child Health Hospital, Chengdu, Sichuan, ChinaSichuan Provincial Hospital for Women and Children, Affiliated Women and Children's Hospital of Chengdu Medical College, Chengdu, Sichuan, ChinaSichuan Provincial Hospital for Women and Children, Affiliated Women and Children's Hospital of Chengdu Medical College, Chengdu, Sichuan, ChinaChengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, ChinaHealthcare Department, Chengdu Jinjiang District Maternal and Child Health Hospital, Chengdu, Sichuan, ChinaChengdu Tianyi Cuisine Nutritional Food Co., Ltd., Chengdu, Sichuan, ChinaSichuan Provincial Hospital for Women and Children, Affiliated Women and Children's Hospital of Chengdu Medical College, Chengdu, Sichuan, ChinaChengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, ChinaWomen Health Department, Chengdu Jintang District Maternal and Child Health Hospital, Chengdu, Sichuan, ChinaHealthcare Department, Chengdu Jinniu District Maternal and Child Health Hospital, Chengdu, Sichuan, ChinaSichuan Provincial Hospital for Women and Children, Affiliated Women and Children's Hospital of Chengdu Medical College, Chengdu, Sichuan, ChinaBackgroundIncreased post-prandial glycemic excursions contribute to the development of diabetes and have been observed in women with recent gestational diabetes mellitus (GDM) and with normal glucose tolerance at post-partum. As a convenient meal replacement, low-GI biscuits are helpful for improving glycemic excursions in patients with type 2 diabetes. However, it is unknown whether low-GI biscuits as pre-loads or mid-meal snacks have a better effect in diminishing post-prandial glycemic excursions from the individual level in women with recent GDM. Therefore, the aim of this trial is to tailor a better dietary strategy utilizing low-GI biscuits (Fitmeal) to improve post-prandial glycemic excursions through within-subject comparison in such a population and observe the long-term effect of a tailored dietary approach in glycemic control.MethodsWe have designed a two-phase trial including a randomized, crossover, non-blinded trial in the first phase, followed by a 4-week tailored intervention in the second phase. A total of 52 post-partum women with recent GDM will be allocated into four meal plans: (1) Fitmeal pre-load 30 min before standard lunch meal (P+L), (2) Fitmeal as a mid-meal snack 2 h before standard lunch meal (S+L), (3) isocaloric standard control with co-ingestion of Fitmeal and standard lunch meal (CL) at the same time, and (4) placebo control with 200 ml of water taken 30 min before standard lunch meal (W + L), on four consecutive days. Acute post-prandial glycemic response (PGR) measured by continuous glucose monitoring (CGM) will be compared among the four meals. In the second phase, all participants will receive a 4-week tailored intervention using Fitmeal as pre-loads or mid-meal snacks based on within-subject PGR results from the first phase. Glycemic metrics, dietary behaviors, and psychosocial factors (e.g., quality of life, self-efficacy, perceived stress, and depression) will be examined at baseline and end-point.DiscussionThis trial is expected to optimize the use of low-GI biscuits as pre-loads or mid-meal snacks in improving individual post-prandial glycemic excursions among women with recent GDM. Furthermore, the findings of this study will provide novel information on how to deliver an effective dietary intervention at the individual level and guide future clinical practice of medical nutrition therapy for diabetes prevention.Trial registration numberChinese clinical trial registry, ChiCTR2200060923.https://www.frontiersin.org/articles/10.3389/fnut.2023.1122102/fullgestational diabetespre-loadpost-prandial glycaemic responsecontinuous glucose monitoringglycaemic index
spellingShingle Chunrong Li
Chunrong Li
Yan Gao
Tongyong Luo
Shiji Qin
Xue Yao
Ye Wen
Xue Wang
Jing Zhang
Qiong Zhong
Hao Shi
Jing Liu
Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored intervention
Frontiers in Nutrition
gestational diabetes
pre-load
post-prandial glycaemic response
continuous glucose monitoring
glycaemic index
title Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored intervention
title_full Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored intervention
title_fullStr Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored intervention
title_full_unstemmed Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored intervention
title_short Effects of low-GI biscuits as pre-loads or mid-meal snacks on post-prandial glycemic excursions in women with recent gestational diabetes: A protocol for a randomized crossover trial and an extended tailored intervention
title_sort effects of low gi biscuits as pre loads or mid meal snacks on post prandial glycemic excursions in women with recent gestational diabetes a protocol for a randomized crossover trial and an extended tailored intervention
topic gestational diabetes
pre-load
post-prandial glycaemic response
continuous glucose monitoring
glycaemic index
url https://www.frontiersin.org/articles/10.3389/fnut.2023.1122102/full
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