Impact of Antioxidant-rich Supplementation on Skin Carotenoids Status, Antioxidant Status and Cardiometabolic Health in Overweight and Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change in Skin Carotenoid Score Measured by Prysm iO™ from Baseline to Week 12
研究概览
简要总结
This study aims to evaluate the effects of antioxidant-rich supplementation on skin carotenoid status, antioxidant status, and cardiometabolic health in overweight and obese individuals. The study may provide additional scientific evidence to support the further refinement of current dietary and nutritional recommendations.
详细描述
This study will be a single-blind, randomized, parallel-group trial, and all participants will complete a 12-week study period. A total of 66 participants will be recruited and randomly assigned to continue their habitual diet with or without antioxidant-rich supplementation. This study aims to investigate whether antioxidant-rich supplementation will influence body composition, skin carotenoid status, antioxidant status, and cardiometabolic health. The study will comprise 1 screening visit and 4 test visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent (AMT score ≥ 8 for older adults [65-70 years old])
- •Adults 21-70 years old
- •English-literate
- •Have venous access sufficient to allow for blood sampling as per the protocol
- •No drastic change of diet for the past 1 year
- •If taking medication, has been consistently taking antihypertensive/cholesterol-lowering/type-2 diabetic medication for more than 3 years prior to starting the study
排除标准
- •Weight change > 3kg in the past 3 months
- •Exercising vigorously over the past 3 months
- •Taking medications or dietary supplements which may impact eye/skin health
- •Taking lipid-lowering and blood pressure controlling medications less than 3 years
- •Drinking more than 2 alcoholic drinks per day
- •Pregnant, lactating, or planning pregnancy in the next 6 months
研究组 & 干预措施
Control
Maintained habitual diet without receving the intervention.
LifePak Elements Supplementation
Consume the LifePak (Elements) every day for 12 weeks.
干预措施: Antioxidant-rich supplementation Element (Dietary Supplement)
LifePak Optimal Supplementation
Consume the LifePak (Optimal) every day for 12 weeks.
干预措施: Antioxidant-rich supplementation Optimal (Dietary Supplement)
结局指标
主要结局
Change in Skin Carotenoid Score Measured by Prysm iO™ from Baseline to Week 12
时间窗: Week 0, 4, 8, 12
Skin carotenoid status will be assessed using the Prysm iO™ device. The device scans the participant's fingertip and provides a skin carotenoid score, also referred to as the Prysm Score. Results will be reported as the numerical Prysm Score. Higher scores indicate higher skin carotenoid levels.
Mean Change from Baseline in Blood Carotenoid Concentration
时间窗: Week 0 and Week 12
Blood carotenoid concentration will be assessed using blood samples collected from participants. Results will be reported as the mean change from baseline in blood carotenoid concentration at Week 12. Higher concentrations indicate higher circulating carotenoid status.
次要结局
- Mean Change from Baseline in Total Antioxidant Capacity in Blood Samples(Week 0 and Week 12)
- Mean Change from Baseline in Fasting Blood Lipid and Lipoprotein Concentrations(Week 0 and Week 12)
- Mean Change from Baseline in Fasting Blood Glucose Concentration(Week 0 and Week 12)
- Mean Change from Baseline in Fasting Blood Insulin Concentration(Week 0 and Week 12)
- Mean Change from Baseline in Blood Biomarkers of Oxidative Stress: Malondialdehyde and 8-Isoprostane(Week 0 and Week 12)
- Mean Change from Baseline in Skin Autofluorescence Measured by AGE Reader mu Connect(Week 0, 4, 8, 12)
- Mean Change from Baseline in Blood Advanced Glycation End Product Level(Week 0 and Week 12)
- Mean change from baseline in anthropometric and body composition parameters(Week 0, 4, 8, 12)
研究者
Jung Eun Kim
Assistant Professor
National University of Singapore