The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome
研究概览
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Sacramento、California、美国、95816
- UC Davis Department of Dermatology, Clinical Trials Unit
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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.
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The almond dose will be provided as 20% of total energy (20% E) in the diet.
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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.
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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 |
|---|---|---|
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Change in wrinkle severity
大体时间:24 weeks
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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.
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24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in facial pigmentation
大体时间:24 weeks
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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.
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24 weeks
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Change in appearance of facial wrinkles on lateral canthi
大体时间:24 weeks
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Two blinded physician graders will grade the photographs obtained at each of the time points on the lateral canthi ("crow's feet").
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24 weeks
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Change in facial sebum production
大体时间:24 weeks
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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.
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24 weeks
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Change in the serum profile
大体时间:24 weeks
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Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
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24 weeks
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Change in sebum lipid profile
大体时间:24 weeks
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Change in the sebum lipid profile assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
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24 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 1257688
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