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Common Limitations and Challenges of Dietary Clinical Trials for Translation into Clinical Practices.饮食临床试验转化为临床实践的常见局限性和挑战。
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Examining differences between overweight women and men in 12-month weight loss study comparing healthy low-carbohydrate vs. low-fat diets.比较健康低碳水化合物饮食与低脂饮食的 12 个月减肥研究中,超重女性与男性的体重差异。
Int J Obes (Lond). 2021 Jan;45(1):225-234. doi: 10.1038/s41366-020-00708-y. Epub 2020 Nov 14.
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Effects of carbohydrate quality and amount on plasma lactate: results from the OmniCarb trial.碳水化合物质量和数量对血浆乳酸的影响:来自 OmniCarb 试验的结果。
BMJ Open Diabetes Res Care. 2020 Aug;8(1). doi: 10.1136/bmjdrc-2020-001457.
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Carbohydrate quality, glycemic index, glycemic load and cardiometabolic risks in the US, Europe and Asia: A dose-response meta-analysis.碳水化合物质量、血糖指数、血糖负荷与美国、欧洲和亚洲的心血管代谢风险:一项剂量反应荟萃分析。
Nutr Metab Cardiovasc Dis. 2020 Jun 9;30(6):853-871. doi: 10.1016/j.numecd.2019.12.050. Epub 2020 Jan 13.

低升糖指数或低升糖负荷饮食用于超重或肥胖人群。

Low glycaemic index or low glycaemic load diets for people with overweight or obesity.

机构信息

School of Biosciences, Faculty of Health and Medical Sciences, Taylor's University, Subang Jaya, Malaysia.

School of Hospitality Management, Macao Institute for Tourism Studies, Macao, Macao.

出版信息

Cochrane Database Syst Rev. 2023 Jun 22;6(6):CD005105. doi: 10.1002/14651858.CD005105.pub3.

DOI:10.1002/14651858.CD005105.pub3
PMID:37345841
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10313499/
Abstract

BACKGROUND

The prevalence of obesity is increasing worldwide, yet nutritional management remains contentious. It has been suggested that low glycaemic index (GI) or low glycaemic load (GL) diets may stimulate greater weight loss than higher GI/GL diets or other weight reduction diets. The previous version of this review, published in 2007, found mainly short-term intervention studies. Since then, randomised controlled trials (RCTs) with longer-term follow-up have become available, warranting an update of this review.

OBJECTIVES

To assess the effects of low glycaemic index or low glycaemic load diets on weight loss in people with overweight or obesity.

SEARCH METHODS

We searched CENTRAL, MEDLINE, one other database, and two clinical trials registers from their inception to 25 May 2022. We did not apply any language restrictions.

SELECTION CRITERIA

We included RCTs with a minimum duration of eight weeks comparing low GI/GL diets to higher GI/GL diets or any other diets in people with overweight or obesity.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methods. We conducted two main comparisons: low GI/GL diets versus higher GI/GL diets and low GI/GL diets versus any other diet. Our main outcomes included change in body weight and body mass index, adverse events, health-related quality of life, and mortality. We used GRADE to assess the certainty of the evidence for each outcome.

MAIN RESULTS

In this updated review, we included 10 studies (1210 participants); nine were newly-identified studies. We included only one study from the previous version of this review, following a revision of inclusion criteria. We listed five studies as 'awaiting classification' and one study as 'ongoing'. Of the 10 included studies, seven compared low GI/GL diets (233 participants) with higher GI/GL diets (222 participants) and three studies compared low GI/GL diets (379 participants) with any other diet (376 participants). One study included children (50 participants); one study included adults aged over 65 years (24 participants); the remaining studies included adults (1136 participants). The duration of the interventions varied from eight weeks to 18 months. All trials had an unclear or high risk of bias across several domains.  Low GI/GL diets versus higher GI/GL diets Low GI/GL diets probably result in little to no difference in change in body weight compared to higher GI/GL diets (mean difference (MD) -0.82 kg, 95% confidence interval (CI) -1.92 to 0.28; I = 52%; 7 studies, 403 participants; moderate-certainty evidence). Evidence from four studies reporting change in body mass index (BMI) indicated low GI/GL diets may result in little to no difference in change in BMI compared to higher GI/GL diets (MD -0.45 kg/m, 95% CI -1.02 to 0.12; I = 22%; 186 participants; low-certainty evidence)at the end of the study periods. One study assessing participants' mood indicated that low GI/GL diets may improve mood compared to higher GI/GL diets, but the evidence is very uncertain (MD -3.5, 95% CI -9.33 to 2.33; 42 participants; very low-certainty evidence). Two studies assessing adverse events did not report any adverse events; we judged this outcome to have very low-certainty evidence. No studies reported on all-cause mortality.    For the secondary outcomes, low GI/GL diets may result in little to no difference in fat mass compared to higher GI/GL diets (MD -0.86 kg, 95% CI -1.52 to -0.20; I = 6%; 6 studies, 295 participants; low certainty-evidence). Similarly, low GI/GL diets may result in little to no difference in fasting blood glucose level compared to higher GI/GL diets (MD 0.12 mmol/L, 95% CI 0.03 to 0.21; I = 0%; 6 studies, 344 participants; low-certainty evidence).  Low GI/GL diets versus any other diet Low GI/GL diets probably result in little to no difference in change in body weight compared to other diets (MD -1.24 kg, 95% CI -2.82 to 0.34; I = 70%; 3 studies, 723 participants; moderate-certainty evidence). The evidence suggests that low GI/GL diets probably result in little to no difference in change in BMI compared to other diets (MD -0.30 kg in favour of low GI/GL diets, 95% CI -0.59 to -0.01; I = 0%; 2 studies, 650 participants; moderate-certainty evidence). Two adverse events were reported in one study: one was not related to the intervention, and the other, an eating disorder, may have been related to the intervention. Another study reported 11 adverse events, including hypoglycaemia following an oral glucose tolerance test. The same study reported seven serious adverse events, including kidney stones and diverticulitis. We judged this outcome to have low-certainty evidence. No studies reported on health-related quality of life or all-cause mortality. For the secondary outcomes, none of the studies reported on fat mass. Low GI/GL diets probably do not reduce fasting blood glucose level compared to other diets (MD 0.03 mmol/L, 95% CI -0.05 to 0.12; I = 0%; 3 studies, 732 participants; moderate-certainty evidence).  AUTHORS' CONCLUSIONS: The current evidence indicates there may be little to no difference for all main outcomes between low GI/GL diets versus higher GI/GL diets or any other diet. There is insufficient information to draw firm conclusions about the effect of low GI/GL diets on people with overweight or obesity. Most studies had a small sample size, with only a few participants in each comparison group. We rated the certainty of the evidence as moderate to very low. More well-designed and adequately-powered studies are needed. They should follow a standardised intervention protocol, adopt objective outcome measurement since blinding may be difficult to achieve, and make efforts to minimise loss to follow-up. Furthermore, studies in people from a wide range of ethnicities and with a wide range of dietary habits, as well as studies in low- and middle-income countries, are needed.

摘要

背景

肥胖的流行率在全球范围内呈上升趋势,但营养管理仍然存在争议。有人认为,低升糖指数(GI)或低升糖负荷(GL)饮食可能比高升糖指数/GL 饮食或其他减肥饮食更能促进体重减轻。本综述的前一版本于 2007 年发表,主要收录了短期干预研究。此后,提供了具有更长随访时间的随机对照试验(RCT),这使得本综述需要更新。

目的

评估低升糖指数或低升糖负荷饮食在超重或肥胖人群中减肥的效果。

检索方法

我们检索了 CENTRAL、MEDLINE、一个其他数据库以及两个临床试验注册库,检索时间均从建库至 2022 年 5 月 25 日。我们没有对语言进行任何限制。

选择标准

我们纳入了比较低 GI/GL 饮食与高 GI/GL 饮食或任何其他饮食在超重或肥胖人群中减肥效果的 RCT,其持续时间至少为 8 周。

数据收集和分析

我们使用标准的 Cochrane 方法。我们进行了两项主要比较:低 GI/GL 饮食与高 GI/GL 饮食和低 GI/GL 饮食与任何其他饮食。我们的主要结局包括体重和体重指数的变化、不良事件、健康相关生活质量和死亡率。我们使用 GRADE 评估每个结局的证据确定性。

主要结果

在本次更新的综述中,我们纳入了 10 项研究(1210 名参与者);其中 9 项是新发现的研究。我们只纳入了前一版本综述中的一项研究,对纳入标准进行了修订。我们将 5 项研究列为“待分类”,1 项研究列为“正在进行”。在纳入的 10 项研究中,7 项比较低 GI/GL 饮食(233 名参与者)与高 GI/GL 饮食(222 名参与者),3 项比较低 GI/GL 饮食(379 名参与者)与任何其他饮食(376 名参与者)。其中 1 项研究纳入了儿童(50 名参与者);1 项研究纳入了年龄超过 65 岁的成年人(24 名参与者);其余研究均纳入了成年人(1136 名参与者)。干预的持续时间从 8 周到 18 个月不等。所有试验在多个领域都存在不确定或高偏倚风险。低 GI/GL 饮食与高 GI/GL 饮食相比,低 GI/GL 饮食可能对体重变化没有影响或影响很小(MD-0.82kg,95%置信区间(CI)-1.92 至 0.28;I²=52%;7 项研究,403 名参与者;中等确定性证据)。四项研究报告了体重指数(BMI)的变化,结果表明,低 GI/GL 饮食可能对 BMI 的变化没有影响或影响很小(MD-0.45kg/m,95%CI-1.02 至 0.12;I²=22%;186 名参与者;低确定性证据)。一项研究评估了参与者的情绪,结果表明,低 GI/GL 饮食可能比高 GI/GL 饮食更能改善情绪,但证据非常不确定(MD-3.5,95%CI-9.33 至 2.33;42 名参与者;非常低确定性证据)。两项评估不良事件的研究没有报告任何不良事件;我们认为这个结果具有非常低的确定性证据。没有研究报告全因死亡率。对于次要结局,低 GI/GL 饮食与高 GI/GL 饮食相比,可能对脂肪量的变化没有影响或影响很小(MD-0.86kg,95%CI-1.52 至-0.20;I²=6%;6 项研究,295 名参与者;低确定性证据)。同样,低 GI/GL 饮食与高 GI/GL 饮食相比,可能对空腹血糖水平的变化没有影响或影响很小(MD0.12mmol/L,95%CI0.03 至 0.21;I²=0%;6 项研究,344 名参与者;低确定性证据)。低 GI/GL 饮食与任何其他饮食相比,低 GI/GL 饮食可能对体重变化没有影响或影响很小(MD-1.24kg,95%CI-2.82 至 0.34;I²=70%;3 项研究,723 名参与者;中等确定性证据)。证据表明,低 GI/GL 饮食与任何其他饮食相比,可能对 BMI 的变化没有影响或影响很小(MD-0.30kg,有利于低 GI/GL 饮食,95%CI-0.59 至-0.01;I²=0%;2 项研究,650 名参与者;中等确定性证据)。一项研究报告了两项不良事件:一项与干预无关,另一项为饮食失调,可能与干预有关。另一项研究报告了 11 项不良事件,包括口服葡萄糖耐量试验后的低血糖。同一项研究报告了 7 项严重不良事件,包括肾结石和憩室炎。我们认为这个结果具有低确定性证据。没有研究报告健康相关生活质量或全因死亡率。对于次要结局,没有研究报告脂肪量。与其他饮食相比,低 GI/GL 饮食可能不会降低空腹血糖水平(MD0.03mmol/L,95%CI-0.05 至 0.12;I²=0%;3 项研究,732 名参与者;中等确定性证据)。

作者结论

目前的证据表明,低升糖指数/低升糖负荷饮食与高升糖指数/GL 饮食或任何其他饮食相比,所有主要结局可能差异不大。关于低升糖指数/低升糖负荷饮食对超重或肥胖人群的影响,目前尚无确切结论。大多数研究样本量较小,每组参与者人数较少。我们对证据的确定性评为中等至非常低。需要更多设计良好且充分有力的研究。它们应该遵循标准化的干预方案,采用客观的结果测量方法,因为可能难以实现盲法,并且努力减少失访。此外,还需要在来自不同种族和饮食习惯广泛的人群中以及在中低收入国家进行研究。