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

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.

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