Citrus supplementation in subjective cognitive decline: results of a 36-week, randomized, placebo-controlled trial.

IF 4.4 2区 医学 Q1 NUTRITION & DIETETICS Nutrition Journal Pub Date : 2024-11-01 DOI:10.1186/s12937-024-01039-8
Samantha Galluzzi, Moira Marizzoni, Elena Gatti, Natale Salvatore Bonfiglio, Annamaria Cattaneo, Francesco Epifano, Giovanni B Frisoni, Salvatore Genovese, Andrea Geviti, Lorenzo Marchetti, Giovanni Sgrò, Claudio Singh Solorzano, Michela Pievani, Serena Fiorito
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Abstract

Background: Developing interventions for older adults with subjective cognitive decline (SCD) has the potential to prevent dementia in this at-risk group. Preclinical models indicate that Citrus-derived phytochemicals could benefit cognition and inflammatory processes, but results from clinical trials are still preliminary. The aim of this study is to determine the effects of long-term supplementation with Citrus peel extract on cognitive performance and inflammation in individuals with SCD.

Methods: Eighty participants were randomly assigned to active treatment (400 mg of Citrus peel extract containing 3.0 mg of naringenin and 0.1 mg of auraptene) or placebo at 1:1 ratio for 36 weeks. The primary endpoint was the change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score across the 36-week trial period. Other cognitive outcomes included tests and scales evaluating verbal memory, attention, executive and visuospatial functions, and memory concerns. The secondary endpoint was the change of interleukin-8 (IL-8) levels over the 36-week trial period in a subsample of 60 consecutive participants. An Intention-to-treat approach with generalized linear mixed models was used for data analysis.

Results: The RBANS total score showed significant improvement in both Citrus peel extract and placebo groups at 36 weeks (p for time < .001, d = 0.36, p time x treatment = .910). Significant time effects were also found in cognitive domains of short- and long-term verbal memory (p < .001) and scales of subjective memory (p < .01), with no significant time x treatment interaction. The largest effect sizes were observed in verbal memory in the placebo group (d = 0.69 in short-term, and d = 0.78 in long-term verbal memory). Increased IL-8 levels were found at 36-week follow-up in both Citrus peel extract and placebo groups (p for time = .010, d = 0.21, p time x treatment = .772). Adverse events were balanced between groups.

Conclusions: In this randomized clinical trial, long-term Citrus peel extract supplementation did not show cognitive benefits over placebo in participants with SCD, possibly due to high placebo response. These findings might have specific implications for designing future nutraceutical trials in individuals experiencing SCD.

Trial registration: The trial has been registered at the United States National Library of Medicine at the National Institutes of Health Registry of Clinical Trials under the code NCT04744922 on February 9th, 2021 ( https://www.

Clinicaltrials: gov/ct2/show/NCT04744922 ).

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柑橘补充剂对主观认知能力下降的影响:为期 36 周的随机安慰剂对照试验结果。
背景:为患有主观认知能力下降(SCD)的老年人制定干预措施,有可能预防这一高风险群体患上痴呆症。临床前模型表明,柑橘类植物化学物质可有益于认知和炎症过程,但临床试验的结果仍是初步的。本研究旨在确定长期补充柑橘皮提取物对 SCD 患者认知能力和炎症的影响:80名参与者按1:1的比例随机分配接受积极治疗(400毫克柑橘皮提取物,含3.0毫克柚皮苷和0.1毫克枳皮苷)或安慰剂,为期36周。主要终点是神经心理状态评估可重复性电池(RBANS)总分在36周试验期间的变化。其他认知结果包括评估言语记忆、注意力、执行和视觉空间功能以及记忆问题的测试和量表。次要终点是 60 名连续参与者的子样本在 36 周试验期间白细胞介素-8(IL-8)水平的变化。数据分析采用了广义线性混合模型的意向治疗方法:结果:在 36 周时,柑橘皮提取物组和安慰剂组的 RBANS 总分均有显著改善(P 为时间结论):在这项随机临床试验中,与安慰剂相比,长期补充柑橘皮提取物并未对 SCD 患者的认知能力产生益处,这可能是由于安慰剂的高反应所致。这些发现可能会对今后设计针对 SCD 患者的营养保健品试验产生具体影响:该试验已于2021年2月9日在美国国立医学图书馆的国立卫生研究院临床试验登记处登记,代码为NCT04744922 ( https://www.Clinicaltrials: gov/ct2/show/NCT04744922 )。
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来源期刊
Nutrition Journal
Nutrition Journal NUTRITION & DIETETICS-
CiteScore
9.80
自引率
0.00%
发文量
68
审稿时长
4-8 weeks
期刊介绍: Nutrition Journal publishes surveillance, epidemiologic, and intervention research that sheds light on i) influences (e.g., familial, environmental) on eating patterns; ii) associations between eating patterns and health, and iii) strategies to improve eating patterns among populations. The journal also welcomes manuscripts reporting on the psychometric properties (e.g., validity, reliability) and feasibility of methods (e.g., for assessing dietary intake) for human nutrition research. In addition, study protocols for controlled trials and cohort studies, with an emphasis on methods for assessing dietary exposures and outcomes as well as intervention components, will be considered. Manuscripts that consider eating patterns holistically, as opposed to solely reductionist approaches that focus on specific dietary components in isolation, are encouraged. Also encouraged are papers that take a holistic or systems perspective in attempting to understand possible compensatory and differential effects of nutrition interventions. The journal does not consider animal studies. In addition to the influence of eating patterns for human health, we also invite research providing insights into the environmental sustainability of dietary practices. Again, a holistic perspective is encouraged, for example, through the consideration of how eating patterns might maximize both human and planetary health.
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