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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
64
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.
Virgin coconut oil softgel capsules and maltodextrin powder, matched in presentation to the active regimen.
Eurofins Product Testing Services Ltd (Eurofins Alba)
Edinburgh, United Kingdom
Change from baseline in skin elasticity
Measured by Cutometer, left and right cheeks and centre forehead
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in skin firmness
Measured by Cutometer, left and right cheeks and centre forehead
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in skin hydration
Measured by Corneometer, left and right cheeks and centre forehead
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in skin barrier function
Transepidermal water loss measured by DermaLab SkinLab USB Series TEWL Probe, left and right cheeks and centre forehead
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in skin radiance
Trained assessor global assessment using Visual Analogue Scale
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in fine lines and wrinkles
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
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in hair density
C-Cube 2D image acquisition and analysis
Time frame: Baseline (Day 0), Day 84
Change from baseline in hair shaft thickness
C-Cube 2D image acquisition and analysis
Time frame: Baseline (Day 0), Day 84
Change from baseline in hair count
Baseline (Day 0), Day 84
Time frame: Baseline (Day 0), Day 84
Change from baseline in sleep quality
Pittsburgh Sleep Quality Index (PSQI) score. Lower scores indicate better sleep quality.
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in perceived vitality and energy
RAND-36 Vitality subscore (four-question set)
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in sexual wellbeing
Arizona Sexual Experiences Scale (ASEX). Higher scores indicate greater sexual dysfunction.
Time frame: Baseline (Day 0), Day 28, Day 84
Change from baseline in cognitive performance
Symbol Digit Modalities Test (oral SDMT), raw and Z-scores, administered by the study doctor
Time frame: Baseline (Day 0), Day 84
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