Intermittent fasting for systemic triglyceride metabolic reprogramming (IFAST): Design and methods of a prospective, randomized, controlled trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-09-17 DOI:10.1016/j.cct.2024.107698

Jacob A. Quaytman , Natalie L. David , Sharini Venugopal , Tânia Amorim , Britney Beatrice , Frederico G.S. Toledo , Rachel G. Miller , Matthew L. Steinhauser , Pouneh K. Fazeli

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引用次数: 0

Abstract

Background

Caloric restriction prolongs lifespan in model organisms and improves metrics of aging-related diseases in humans, but daily compliance is challenging. Intermittent fasting improves metrics of lipid and glucose metabolism in the setting of weight loss but whether these metrics are improved independent of weight loss is not known.

Methods

We seek to address this gap with IFAST, a single-center, three-arm, prospective, randomized, controlled clinical trial. Eligible study participants are adults with no chronic medical conditions beyond prediabetes or overweight but who are at high risk for type 2 diabetes mellitus (T2D), defined as having a history of gestational diabetes or a first-degree relative with T2D. Participants will be randomized in a 1:2:2 schema to either a control group, a fasting group, or a fasting/weight maintenance group. The fasting groups will complete a 24-h fast one day per week for 12 weeks. The key mechanistic endpoint is change in triglyceride composition (defined by carbon content and degree of saturation) as measured by longitudinal metabolomics. The key safety endpoint is percent change from baseline in bone volume fraction (BV/TV; high-resolution peripheral quantitative CT) at the radius in the fasting group. Secondary endpoints include measures of insulin sensitivity (hyperinsulinemic-euglycemic clamp), clinical lipid profiling, systemic inflammation markers, hunger assessment, bone density, and bone microarchitecture with high-resolution peripheral quantitative CT.

Conclusion

IFAST will investigate intrinsic metabolic benefits of intermittent fasting beyond weight loss.

Trial registration

ClinicalTrials.gov ID NCT05722873.

查看原文本刊更多论文

间歇性禁食促进全身甘油三酯代谢重编程（IFAST）：前瞻性随机对照试验的设计与方法。

背景：热量限制可延长模式生物的寿命，并改善人类衰老相关疾病的指标，但每日达标具有挑战性。间歇性禁食能在减轻体重的情况下改善脂质和葡萄糖代谢指标，但这些指标的改善是否与体重减轻无关尚不清楚：IFAST是一项单中心、三臂、前瞻性、随机对照临床试验。符合条件的研究参与者是除了糖尿病前期或超重之外没有其他慢性疾病，但有 2 型糖尿病（T2D）高风险的成年人，即有妊娠糖尿病史或一级亲属患有 T2D。参与者将按 1:2:2 的比例随机分配到对照组、禁食组或禁食/体重维持组。禁食组将在 12 周内每周有一天禁食 24 小时。关键的机理终点是通过纵向代谢组学测量甘油三酯成分的变化（以碳含量和饱和度定义）。关键的安全性终点是禁食组桡骨小梁骨量与基线相比的百分比变化。次要终点包括胰岛素敏感性测量（高胰岛素血糖钳夹）、临床脂质分析、全身炎症标志物、饥饿评估、骨密度和高分辨率外周定量 CT 骨微结构：试验注册：试验注册：ClinicalTrials.gov ID NCT05722873。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.