The Effect of Almonds on Skin Lipids and Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in wrinkle depth
研究概览
简要总结
Investigators hypothesize that regular consumption of almonds will augment the long chain fatty acid profile and the alpha-tocopherol levels, improve the skin barrier function, and improve the appearance of facial wrinkles in post-menopausal women.
详细描述
Primary Endpoint:
A) Change in wrinkle depth. Full facial photographs will be obtained at baseline, 8 weeks, and 16 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. This system can assess average wrinkle depth. The PI has already validated this measurement tool against standard clinical grading of facial wrinkles[13].
Secondary Endpoint:
A) Change in clinical appearance of facial wrinkles on lateral canthi: Two blinded dermatologists will grade the photographs obtained at each of the time points on the lateral canthi ("crow's feet"). The dermatologists will not know which group the subjects were in.
B) Change in facial sebum production through the use of a Sebumeter, a commonly used device that measures sebum excretion rate [13,17]. Sebum excretion rate will be measured at baseline, 8 weeks, and 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women
- •Fitzpatrick skin types 1 and 2
- •Able to follow dietary intervention and attend all study visits
排除标准
- •Those with a nut allergy
- •Current smokers
- •Those that have smoked within the past year
- •Former smokers with greater than a 20 pack-year history of smoking within the past 20 years will be excluded.
- •Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)
- •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 high antioxidant supplements and daily food sources listed below, during the washout and intervention.
研究组 & 干预措施
Almond arm
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.
干预措施: Almonds (Other)
Western diet Snack (Granola bar + Pretzels)
The control snack will be a typical western diet snack (see Table 1). The calorie-matched control snack will be commercially available individually wrapped food products such as a small granola bar + pretzels.
结局指标
主要结局
Change in wrinkle depth
时间窗: 16 weeks
次要结局
- Change in clinical appearance of facial wrinkles on lateral canthi(16 weeks)
- Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content(16-weeks)
- Change in facial sebum production through the use of a Sebumeter(16 weeks)
- Change in serum and sebum lipid profiles(16 weeks)