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The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome

2021年7月6日 更新者:University of California, Davis
The investigator hypothesizes that regular consumption of almonds will 1) improve the facial wrinkle severity in post-menopausal women, 2) improve the evenness of facial skin pigmentation, 3) diversify the gut microbiome and increase the short chain fatty acids in the blood, and 4) improve the skin barrier biophysical properties.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study will be a 24 week supplementation study that utilizes two study groups: 1) control group and 2) almond supplementation: 20% energy intake. This will be a randomized, rater-blinded, and controlled study. There will be a total of 60 subjects, with 30 assigned to the control group and 30 assigned to almond supplementation.

Subjects will be recruited from the UC Davis Dermatology Clinic, UC Davis Main campus, California State University- Sacramento, and from the surrounding community physicians and the community in a 100 mile radius. The greater Sacramento area has a population of over 2 million to draw from and recruitment will be conducted through the use of Social Media and flyer based recruitment. Postmenopausal women have previous been recruited successfully in a previous study. The study visits will be performed at the UC Davis Dermatology Clinic located at 3301 C Street, Suite 1400, Sacramento, CA 95816.

Investigators will collect medical history and current medications from study participants- this is outlined in the HIPAA form. The two intervention groups will consist of those receiving almonds and those that are receiving a calorie matched snack. The almond dose will be provided as 20% of total energy (20% E) in the diet. This dose was selected based on a previous randomized trial examining lipid parameters in response to 0, 10%, and 20% E as dietary almonds and a recent meta-analysis of intervention trials of tree nuts [5, 6]. The control snack will be a typical western diet snack (see Table 1) . The calorie matched snacks are commercially available prepackaged snack items that will be purchased from Costco. Once a subject has met inclusion criteria and has signed IRB consent, anthropometric data will be obtained, 1-24 hour recall will be collected, training will be provided for recording dietary records, and estimated caloric needs will be calculated. Estimated energy needs (EER) will be determined using the Mifflin-St. Jeor equation and total daily energy needs (TDE) calculated as EER x activity factor of 1.3-1.5 for sedentary to average activity, or a higher activity level as indicated. A representative example of a 60 year old woman, 5'4", 140 pounds with typical activity level yields TDE of approximately 1,600 - 1,800 kcal/day, and 20% E of 320-360 kcal/day. The intervention and control snacks would be 56.7 g of almonds and 56.7 g pretzel + one-24 g chewy granola bar, respectively.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Sacramento、California、美国、95816
        • UC Davis Department of Dermatology, Clinical Trials Unit

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Postmenopausal women
  • Fitzpatrick skin types 1 and 2
  • Able to follow dietary intervention and attend all study visits

Exclusion Criteria:

  • Those with a nut allergy
  • Current smokers, those that have smoked within the past year, and former smokers with greater than a 20 pack-year history of smoking, as smoking is a independent risk factor and serves as a confounder for the development of facial wrinkles
  • Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos), as this can be a confounder for the development of facial wrinkles
  • Those that already obtain 20% of their energy intake from nut consumption
  • Those with implausible reported energy intakes of <1,000 kcal/d or >3,000 kcal/d
  • Individuals who are unwilling to discontinue vitamin E containing supplements and food sources during the washout and intervention

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Almond supplementation
The almond dose will be provided as 20% of total energy (20% E) in the diet. This dose was selected based on a previous randomized trial examining lipid parameters in response to 0, 10%, and 20% E as dietary almonds and a recent meta-analysis of intervention trials.
The almond dose will be provided as 20% of total energy (20% E) in the diet.
无干预:Control snack
The control snack will be a typical western diet snack. The calorie-matched control snack will be commercially available individually wrapped food products.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in wrinkle severity
大体时间:24 weeks
Photographs will be obtained at baseline, 8 weeks, 16 weeks, and 24 weeks. The images will be obtained with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) that has standardized positioning and lighting and iPad. The investigator has already validated this measurement tool against standard clinical grading of facial wrinkles.
24 weeks

次要结果测量

结果测量
措施说明
大体时间
Change in facial pigmentation
大体时间:24 weeks
Photographs will be obtained at baseline, 8 weeks, 16 weeks, and 24 weeks. The images will be obtained with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) that has standardized positioning and lighting and iPad. This system can assess facial pigmentation evenness and average intensity. The investigator has already validated this measurement tool against standard clinical grading of facial pigmentation.
24 weeks
Change in appearance of facial wrinkles on lateral canthi
大体时间:24 weeks
Two blinded physician graders will grade the photographs obtained at each of the time points on the lateral canthi ("crow's feet").
24 weeks
Change in facial sebum production
大体时间:24 weeks
Change in facial sebum production through the use of a Sebumeter, a commonly used device that measures sebum excretion rate. Sebum excretion rate will be measured at baseline, 8 weeks, 16 weeks, and 24 weeks.
24 weeks
Change in the serum profile
大体时间:24 weeks
Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
24 weeks
Change in sebum lipid profile
大体时间:24 weeks
Change in the sebum lipid profile assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
24 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年10月22日

初级完成 (实际的)

2021年6月1日

研究完成 (实际的)

2021年6月22日

研究注册日期

首次提交

2018年10月30日

首先提交符合 QC 标准的

2018年10月31日

首次发布 (实际的)

2018年11月5日

研究记录更新

最后更新发布 (实际的)

2021年7月7日

上次提交的符合 QC 标准的更新

2021年7月6日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1257688

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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