Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age (IDF-AID-1)
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
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.
연구 개요
상태
정황
상세 설명
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
Enrolment of a minimum of 60 healthy participants was planned in order to complete with a minimum of 50 evaluable participants, targeting a 2:1 completion ratio between the active and placebo groups. The sample size was set on feasibility grounds rather than by formal power calculation.
Statistical analysis
Quantitative responses were modelled as within-subject changes from baseline using mixed models with subject as a random effect, fitted in R, with covariates comprising baseline response level, time, product and their interaction. Handling of baseline measures followed European Medicines Agency (2013) guidance. Where only a single post-baseline measure existed, a simple linear model was fitted. Questionnaire data were analysed non-parametrically where distributional assumptions were violated. Statistical significance was defined at the 5% level. No adjustment for multiple comparisons was applied, and results should be interpreted accordingly given the number of endpoints assessed.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Edinburgh, 영국, EH1 3RH
- Eurofins Product Testing Services Ltd (Eurofins Alba)
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- - 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
Combined regimen of Advanced ID Brain, Heart and Eye Omega Gel Capsules and Advanced ID Longevity and Collagen Complex Powder.
Contains marine collagen (fish) and bovine gelatine.
다른 이름들:
|
|
위약 비교기: 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.
|
Virgin coconut oil softgel capsules and maltodextrin powder, matched in presentation to the active regimen.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in skin elasticity
기간: Baseline (Day 0), Day 28, Day 84
|
Measured by Cutometer, left and right cheeks and centre forehead
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in skin firmness
기간: Baseline (Day 0), Day 28, Day 84
|
Measured by Cutometer, left and right cheeks and centre forehead
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in skin hydration
기간: Baseline (Day 0), Day 28, Day 84
|
Measured by Corneometer, left and right cheeks and centre forehead
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in skin barrier function
기간: 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
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in skin radiance
기간: Baseline (Day 0), Day 28, Day 84
|
Trained assessor global assessment using Visual Analogue Scale
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in fine lines and wrinkles
기간: 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
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in hair density
기간: Baseline (Day 0), Day 84
|
C-Cube 2D image acquisition and analysis
|
Baseline (Day 0), Day 84
|
|
Change from baseline in hair shaft thickness
기간: Baseline (Day 0), Day 84
|
C-Cube 2D image acquisition and analysis
|
Baseline (Day 0), Day 84
|
|
Change from baseline in hair count
기간: Baseline (Day 0), Day 84
|
Baseline (Day 0), Day 84
|
Baseline (Day 0), Day 84
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in sleep quality
기간: Baseline (Day 0), Day 28, Day 84
|
Pittsburgh Sleep Quality Index (PSQI) score.
Lower scores indicate better sleep quality.
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in perceived vitality and energy
기간: Baseline (Day 0), Day 28, Day 84
|
RAND-36 Vitality subscore (four-question set)
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in sexual wellbeing
기간: Baseline (Day 0), Day 28, Day 84
|
Arizona Sexual Experiences Scale (ASEX).
Higher scores indicate greater sexual dysfunction.
|
Baseline (Day 0), Day 28, Day 84
|
|
Change from baseline in cognitive performance
기간: Baseline (Day 0), Day 84
|
Symbol Digit Modalities Test (oral SDMT), raw and Z-scores, administered by the study doctor
|
Baseline (Day 0), Day 84
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in biological age
기간: Baseline (Day 0), Day 84
|
Whole blood collected at baseline and Day 84 for GlycanAge and epigenetic DNA methylation analysis by third-party laboratories.
Analysis outside the scope of the primary study report.
|
Baseline (Day 0), Day 84
|
|
Participant self-perception of product effects
기간: Day 28, Day 84
|
Self-Perception Questionnaire (SPQ), 23 items, 5-point scale
|
Day 28, Day 84
|
|
High-definition digital facial imaging
기간: Baseline (Day 0), Day 28, Day 84
|
Newtone ColorFace imaging, full face and left and right sides, no filters.
Collected for visualisation; no statistical analysis conducted.
|
Baseline (Day 0), Day 28, Day 84
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- IDF_AdvancedID_001
- 217430 (기타 식별자: Eurofins Product Testing Services Ltd)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .