A Randomized, Double-Blind, Placebo Controlled, Single Center Study to Assess the Impact of a Nutritional Supplement on Wellbeing and Nutrient Absorption
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Pharmanex
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Nutrient analysis
研究概览
简要总结
The objective of this placebo controlled randomized research is to demonstrate the health benefits of a carotenoid nutritional supplement as compared to placebo in terms of nutrient levels, quality of life, feelings, of wellness, brain health, energy, immunity, and appearance.
详细描述
Female or male subjects will be enrolled in this single site study to evaluate the efficacy and tolerability of a nutritional supplement. Subjects who sign consent and meet all inclusion criteria and none of the exclusion criteria will be enrolled at the baseline visit. Vital signs will be obtained (height, weight, blood pressure, heart rate). Subjects must meet the study BMI requirements (≥18.5 and ≤29.9 kg/m2 ). Subjects will also complete BioPhotonic Scanner screening. If subjects meet all requirements, they will be randomized to receive either the active nutritional supplement or a placebo. Subjects will undergo phlebotomy for baseline lab work consisting of carotenoid analysis. Subjects will complete the following questionnaires/measurements:
- Quality of Life Questionnaire
- Diet and Lifestyle Questionnaire
- Subject Skin Assessment
- Biophotonic Scanner measurement
- Mini-4 Scanner measurement
The nutritional supplement will be started and the subjects will return to the research center at Weeks 4 and 8 for evaluation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects male or female age 20-65 years old.
- •Subjects who score 30,000 or below on the Pharmanex BioPhotonic Scanner.
- •Subjects of Fitzpatrick skin types I-VI with no known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Subjects must be able to read, understand and provide written informed consent.
- •Individuals must agree to continue to use all regular brands of cosmetics and the assigned test materials for the duration of the study. Individuals must refrain from using any new products other than the assigned test supplements.
- •Subjects must agree to avoid excessive sun exposure (no more than 10-15 minutes of direct sunlight without SPF protection) and the use of artificial tanning methods for the duration of the study.
排除标准
- •Individuals who are participating in any other research study.
- •Subjects who are regularly taking oral nutritional supplements containing carotenoids as specified by the sponsor.
- •Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study supplement.
- •Concurrent therapy with any medication either topical or oral that might interfere with the study.
- •Subjects who are alcohol or narcotic addicts.
- •Subjects who are unwilling to leave their current oral medications unchanged for the duration of the study.
- •Subjects who use an indoor tanning booth.
- •Subjects, who are pregnant, breast feeding or planning a pregnancy.
- •Subjects with clinically significant unstable medical disorders, such as cancer, diabetes, neurodegenerative disorders, active autoimmune disease, liver or kidney disease, schizophrenia, depression, other major mental illness.
- •Subjects who are cigarette smokers.
- •Subjects who regularly use supplements containing >2mg carotenoids such as: LifePak, Beauty Focus Collagen+, ageLOC Youth.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
- •Subjects who are participating in another similar research study.
结局指标
主要结局
Nutrient analysis
时间窗: 8 weeks
Nutrient levels as measured by blood serum carotenoids and correlated to BioPhotonic Scanner and Mini-4 scanner assessment. Higher blood serum carotenoid levels and scan scores indicate greater improvement.
Wellness Assessment
时间窗: 8 weeks
Subject self-assessment of global wellness via questionnaire. Likert Scale: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree, 5=Strongly Agree. Higher score indicates greater satisfaction/improvement.
次要结局
- Product Safety(8 weeks)
- Skin Attribute Assessment(8 weeks)