背景:一些先前的随机临床试验(RCT)测试了可可提取物(CE)的作用,黄烷醇的来源,关于晚年认知已经产生了有希望的发现。使用涵盖多个认知领域的个人神经心理学测试的长期RCT可能会阐明CE的认知作用。
目的:为了测试每日补充CE是否,与安慰剂相比,
方法:可可补充剂和多种维生素结果研究(COSMOS)是CE的2×2阶乘RCT[500mg黄烷醇/d,包括80毫克(-)-表儿茶素]和/或每日多种维生素矿物质补充剂,用于心血管疾病和癌症预防21,442名美国成年人年龄≥60岁。在COSMOS的临床亚队列中有573名参与者(即,COSMOS-Clinic)在基线时完成所有认知测试;其中,492人完成了2年随访评估。主要结果是全球认知(平均11项测试的z分数)。次要结果是情景记忆和执行功能/注意力。重复测量模型用于比较随机组。
结果:参与者的平均年龄(标准差)为69.6(5.3);49.2%为女性。每日补充CE,与安慰剂相比,对整体认知的2-y变化没有显着影响{平均差[95%置信区间(CI)]:-0.01(-0.08,0.05)标准偏差单位(SU)}。CE,与安慰剂相比,对情景记忆[平均差异(95%CI):-0.01(-0.13,0.10)SU]或执行功能/注意力[平均差异(95%CI):0.003(-0.07,0.08)SU]的2-y变化没有显着影响。对多重测试未校正的亚组分析表明,补充CE的认知益处,基线饮食质量较差的人群与安慰剂相比。
结论:在573名进行面对面重复的老年人中,超过2年的详细神经心理学评估,每日补充CE,与安慰剂相比,对全局或特定领域的认知功能没有总体益处。在饮食质量较差的人群中,CE的可能认知益处值得进一步研究。
背景:该试验已在clinicaltrials.gov注册,标识符为NCT02422745。
Some prior randomized clinical trials (RCTs) that tested the effects of cocoa extract (CE), a source of
flavanols, on late-life cognition have yielded promising findings. A long-term RCT using in-person neuropsychological tests covering multiple cognitive domains may clarify the cognitive effects of CE.
To test whether daily supplementation with CE, compared with placebo, produces better cognitive change over 2 y.
The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) is a 2 × 2 factorial RCT of CE [500 mg
flavanols/d, including 80 mg (-)-epicatechin] and/or a daily multivitamin-mineral supplement for cardiovascular disease and cancer prevention among 21,442 United States adults aged ≥60 y. There were 573 participants in the clinic subcohort of COSMOS (that is, COSMOS-Clinic) who completed all cognitive tests at baseline; of these, 492 completed 2-y follow-up assessments. The primary outcome was global cognition (averaging z-scores across 11 tests). Secondary outcomes were episodic memory and executive function/attention. Repeated measures models were used to compare randomized groups.
Participants\' mean age (standard deviation) was 69.6 (5.3); 49.2% were females. Daily supplementation with CE, compared with placebo, had no significant effect on 2-y change in global cognition {mean difference [95% confidence interval (CI)]: -0.01 (-0.08, 0.05) standard deviation units (SU)}. CE, compared with placebo, had no significant effects on 2-y change in episodic memory [mean difference (95% CI): -0.01 (-0.13, 0.10) SU] or executive function/attention [mean difference (95% CI): 0.003 (-0.07, 0.08) SU]. Subgroup analyses uncorrected for multiple-testing suggested cognitive benefits of CE supplementation, compared with placebo among those with poorer baseline diet quality.
Among 573 older adults who underwent repeat in-person, detailed neuropsychological assessments over 2 y, daily CE supplementation, compared with placebo, showed no overall benefits for global or domain-specific cognitive function. Possible cognitive benefits of CE among those with poorer diet quality warrant further study.
This trial was registered at clinicaltrials.gov with identifier - NCT02422745.