A Double-Blind, Randomised, Placebo-Controlled Study Evaluating the Effects of a Novel Multi-Targeted Dermatologist-Formulated Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido, and Longevity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change from baseline in skin elasticity
研究概览
简要总结
This study evaluated the effects of a daily oral supplement regimen (Advanced ID Brain, Heart and Eye Omega Gel Capsules taken with Advanced ID Longevity and Collagen Complex Powder) on measures of skin condition, hair, sleep, energy, cognition and sexual wellbeing in healthy adults aged 35 to 65 years.
Participants were randomised in a 2:1 ratio to receive either the active supplement regimen or a matched placebo regimen once daily with food for 12 weeks. Instrumental skin measurements, trained-assessor visual grading and participant questionnaires were performed at baseline (Day 0), Day 28 and Day 84. Hair imaging and cognitive testing were performed at baseline and Day 84. Whole blood samples were collected at baseline and Day 84 for exploratory epigenetic DNA biological clock age analysis, reported separately.
The study was single-centre, sponsored by IDI Skincare Limited and conducted by Eurofins Product Testing Services Ltd (trading as Eurofins Alba) in Edinburgh, United Kingdom.
详细描述
Study conduct
The study was conducted at a single centre over 12 weeks with three clinic visits: baseline (Day 0), Day 28 and Day 84. At each of the first two visits participants received a four-week supply of their allocated study products together with a diary sheet to record daily consumption and compliance. Participants consumed their allocated products once daily in the morning with food at home. An acclimatisation period preceded instrumental measurements and imaging at each assessment visit. Adverse events were recorded throughout the study period.
Randomisation and blinding
The randomisation schedule was generated by an independent statistician using product codes only, via a centralised electronic randomisation system, with provision for emergency unblinding. Participants and assessors remained blinded to allocation throughout. Analysts were blinded to product identity at the time of statistical analysis.
Sample size
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The randomisation schedule was generated by an independent statistician using product codes only, via a centralised electronic randomisation system with provision for emergency unblinding. Access to the randomisation code was strictly controlled. Statistical analysts were also blinded to product identity at the time of analysis.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 35 to 65 years (30% male : 70% female desired)
- •In generally good health, as determined by medical history questionnaire
- •Free from excessive hair, tattoos, dermatitis or scars on the test areas; males must attend each visit clean shaven, having shaved the day before the appointment
- •Able to read, understand and sign an informed consent agreement
- •Able to communicate well with study personnel and comply with study requirements
- •Hair at least 3 cm long, with no intention of substantial change to hair style
- •Participants on medicinal contraception: stable method for at least 3 months prior to baseline and willing not to change for the study duration
- •Women of childbearing potential: willing to use a reliable method of contraception
- •Participants on hormone replacement therapy: stable HRT for at least 6 months prior to baseline and willing not to change
- •Willing not to change regular food habits or commence any diet or nutritional change
- •Willing to refrain from taking any new dietary supplements other than study products
- •Willing to maintain usual lifestyle habits including exercise regimes
- •Willing to avoid medicated shampoo and conditioner
- •Willing to refrain from dermato-aesthetic facial procedures
- •Willing to refrain from chemical hair styling procedures (colour treatments permitted)
- •Willing to avoid excessive natural sunlight and other avoidable UV sources
- •Willing to remove facial piercings, earrings or jewellery prior to imaging
- •Willing to consent to use of their images by the Sponsor
- •Willing to have photographs taken to record any significant reactions
- •Willing to adhere to all study restrictions and requirements
排除标准
- •- Pregnant, breastfeeding, or of childbearing potential and not using reliable contraception
- •Consumed any food or health supplements (including vitamins, creatine, omegas, collagen) within the 3 months prior to baseline
- •Known allergy or hypersensitivity to any study product ingredient (products contain fish and coconut ingredients)
- •Known allergy or hypersensitivity to any dietary supplements
- •Any systemic condition (acute or chronic) or skin disorder including eczema, psoriasis, acne or diabetes (inactive skin disease for at least 6 months prior to baseline may be accepted at the Project Manager's discretion)
- •History of skin cancer with remission period below 5 years
- •Asthma or other chronic respiratory condition requiring therapy within the last 6 months
- •Any other systemic disease or medical or skin condition which in the opinion of the Project Manager, Study Doctor or Sponsor would affect ability to complete the study
- •Diagnosis of high cholesterol (current or previous)
- •Current treatment with cholesterol lowering medication
- •Family history of high cholesterol (first degree relative)
- •Diagnosis of ischaemic heart disease (current or previous)
- •Diagnosis of peripheral vascular disease or intermittent claudication
- •Diagnosis of stroke (current or previous)
- •Treatment (oral or topical) with tretinoin, isotretinoin or corticosteroids within the 6 months prior to baseline
- •Systemic steroids or anti-inflammatory treatments within the 6 months prior to baseline
- •Medications which may affect sampling or analysis, including metformin, anticoagulants, biological therapies, immunosuppressive or immunomodulating medication, chemotherapy, cytokine or anti-cytokine therapy
- •Surgical or non-surgical dermato-aesthetic facial procedures within the 6 months prior to baseline
- •Facial surgery (excluding dental) within the previous 6 months
- •Diagnosis of facial nerve damage
- •False eyelashes of any type on assessment days
- •Refusal to remove eyebrow make-up
- •Facial or ear piercings that cannot be removed for assessments
- •Low protein diet
- •Vegetarian or vegan diet (study products contain marine collagen and bovine gelatine)
- •Average alcohol consumption greater than 14 units per week
- •Night shift workers or irregular working hours interfering with regular sleep pattern
- •Intention to commence smoking cessation activities or alternative nicotine products during the study
- •Medically diagnosed insomnia
- •Active medically diagnosed alopecia or previous history
- •History of or high risk of blood borne infection (HIV, hepatitis B or C, AIDS)
- •History of problematic blood collections or negative experience during surgery
研究组 & 干预措施
Advanced ID Longevity and Collagen Complex Powder
Two Advanced ID Brain, Heart and Eye Omega Gel Capsules followed by approximately 12 g (one scoop) Advanced ID Longevity and Collagen Complex Powder mixed with 400 ml water, taken orally once daily in the morning with food for 12 weeks.
干预措施: Advanced ID (Dietary Supplement)
Placebo Control
Two VitaMinute Organic Virgin Coconut Oil Softgel Capsules followed by approximately 12 g (one scoop) maltodextrin mixed with 400 ml water, taken orally once daily in the morning with food for 12 weeks.
干预措施: Placebo Control (Dietary Supplement)
结局指标
主要结局
Change from baseline in skin elasticity
时间窗: Baseline (Day 0), Day 28, Day 84
Measured by Cutometer, left and right cheeks and centre forehead
Change from baseline in skin firmness
时间窗: Baseline (Day 0), Day 28, Day 84
Measured by Cutometer, left and right cheeks and centre forehead
Change from baseline in skin hydration
时间窗: Baseline (Day 0), Day 28, Day 84
Measured by Corneometer, left and right cheeks and centre forehead
Change from baseline in skin barrier function
时间窗: Baseline (Day 0), Day 28, Day 84
Transepidermal water loss measured by DermaLab SkinLab USB Series TEWL Probe, left and right cheeks and centre forehead
Change from baseline in skin radiance
时间窗: Baseline (Day 0), Day 28, Day 84
Trained assessor global assessment using Visual Analogue Scale
Change from baseline in fine lines and wrinkles
时间窗: Baseline (Day 0), Day 28, Day 84
Trained assessor grading using Roland Bazin scales for crow's feet wrinkles, crow's feet wrinkle depth and number, forehead wrinkles, glabella wrinkles and underneath eye wrinkles
Change from baseline in hair density
时间窗: Baseline (Day 0), Day 84
C-Cube 2D image acquisition and analysis
Change from baseline in hair shaft thickness
时间窗: Baseline (Day 0), Day 84
C-Cube 2D image acquisition and analysis
Change from baseline in hair count
时间窗: Baseline (Day 0), Day 84
Baseline (Day 0), Day 84
次要结局
- Change from baseline in sleep quality(Baseline (Day 0), Day 28, Day 84)
- Change from baseline in perceived vitality and energy(Baseline (Day 0), Day 28, Day 84)
- Change from baseline in sexual wellbeing(Baseline (Day 0), Day 28, Day 84)
- Change from baseline in cognitive performance(Baseline (Day 0), Day 84)