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Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age (IDF-AID-1)

14 września 2026 zaktualizowane przez: IDI Skincare Limited

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

64

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Zjednoczone Królestwo
      • Edinburgh, Zjednoczone Królestwo, EH1 3RH
        • Eurofins Product Testing Services Ltd (Eurofins Alba)

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Suplement diety: Advanced ID
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.
Inne nazwy:
  • Advanced ID Brain, Heart and Eye Omega Gel Capsules
  • Advanced ID Longevity and Collagen Complex Powder
Komparator placebo: 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.
Suplement diety: Placebo Control
Virgin coconut oil softgel capsules and maltodextrin powder, matched in presentation to the active regimen.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in skin elasticity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline (Day 0), Day 84
C-Cube 2D image acquisition and analysis
Baseline (Day 0), Day 84
Change from baseline in hair shaft thickness
Ramy czasowe: Baseline (Day 0), Day 84
C-Cube 2D image acquisition and analysis
Baseline (Day 0), Day 84
Change from baseline in hair count
Ramy czasowe: Baseline (Day 0), Day 84
Baseline (Day 0), Day 84
Baseline (Day 0), Day 84

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in sleep quality
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in biological age
Ramy czasowe: 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
Ramy czasowe: Day 28, Day 84
Self-Perception Questionnaire (SPQ), 23 items, 5-point scale
Day 28, Day 84
High-definition digital facial imaging
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

IDI Skincare Limited

Współpracownicy

University of Edinburgh
University of Dublin, Trinity College

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

8 grudnia 2025

Zakończenie podstawowe (Rzeczywisty)

5 marca 2026

Ukończenie studiów (Szacowany)

30 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

14 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 września 2026

Pierwszy wysłany (Rzeczywisty)

18 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IDF_AdvancedID_001
  • 217430 (Inny identyfikator: Eurofins Product Testing Services Ltd)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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