Atlantia is a world-class provider of human clinical studies. For over a decade we have delivered clinical results to our many clients around the world, on time and on budget. We strive to offer the highest quality science while maintaining a cost-conscious approach to maximize the value proposition for each of our clients.
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Contents NUTRACEUTICALS & FUNCTIONAL FOODS Introduction.............................................................. 1 Health Areas............................................................. 2 Atlantia Facts............................................................ 4 Facilities.................................................................... 5 Product Areas........................................................... 7 Technologies............................................................ 8 Services.................................................................... 9 Clinical Endpoints................................................... 10
BEAUTY & COSMETICS
Introduction and Product Areas............................ 25 Areas of Expertise.................................................. 26 Clinical Case Study Library.................................... 32 Contact................................................................. 34
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END-TO-END CLINICAL SOLUTIONS
Atlantia is a world class provider of human clinical studies . For over a decade we have delivered clinical results to our many clients around the world, on time and on budget. We strive to offer the highest quality science while maintaining a cost-conscious approach to maximise the value proposition for each of our clients. Our state-of-the-art clinic sites both in Ireland and the USA ensure we can offer multicentre multinational studies of all design types, across a broad and diverse array of health areas and product portfolios. and dedicated team will help you manage all aspects of your clinical project and guide you through the entire process, while keeping you fully informed of progress. Since we own and operate our clinics we can control the variables, including recruitment. Additionally all of our ICH-GCP certified teams are on hand to ensure your data is of the very highest quality and integrity and in strict accordance with the protocol. Our highly qualified
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Health Areas
CLINICAL RESEARCH EXPERTS ACROSS A VARIETY OF HEALTH AREAS
Some of our extensive clinical areas include: healthy ageing, gastrointestinal function and disorder, physical activity and sports performance, nutritional investigations, stress and cognitive health and decline , cardiovascular health, metabolic syndrome, bone and joint health, immune function and microbiome dysbiosis of the gut, skin, vagina and oral cavity.
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Atlantia Facts
ATLANTIA FACTS
ON TIME, ON BUDGET
GCP & COLIPA
EXPERIENCED WITH CLAIM SUBMISSION AND PUBLICATION
OVER 150 STUDIES COMPLETED
CLINICAL STUDY
WE WORK WITH THE TOP MICROBIOME RESEARCHERS WORLDWIDE*
FACILITIES IN BOTH USA & EUROPE
*Based on Expertscape and Claritative Analytics classifications
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Facilities
CLINICAL TRIAL FACILITIES
We own and operate our clinical trial facilities, where our clinical research team: Designs the studies, screens participants, conducts the study visits, collects and stores the biological samples and performs the statistical analysis. All trial activities happen here, under one roof, ensuring data quality and compliance across all functions.
• Our facilities have adaptable clinic rooms to ensure privacy and confidentiality during study visits. • Our clinic rooms are adapted and specialised to meet the needs of each specific trial. • Our central phlebotomy facility allows us to perform multiple and frequent blood sample collections.
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CLINICAL TRIAL FACILITIES
• In our processing lab, we manage many different sample types including urine, faecal, blood, hair, and skin. • We can store samples on site at -20°C and -80°C for the duration of the study and beyond. This allows the conduct of further exploratory analysis even once the trial is completed. • Our file & IP Storage unit is compliant with ICH-GCP standards and is also access and temperature controlled. • This allows our clients to conduct further exploratory analysis even once the trial is completed.
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PROVIDING CLINICAL RESEARCH EXPERTISE TO THE NUTRACEUTICAL, MEDICAL FOOD AND BEAUTY INDUSTRIES Our expert research team will work with sponsor(s) to design and conduct the most suitable study, taking into consideration all the specific requirements for their investigational product(s):
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TECHNOLOGY Atlantia’s research team keeps up to date with the latest advancements in technology and methods. Our research team will assist you selecting the most appropriate technology depending on the product, health area and endpoints of your study.
Video Capsule Endoscopy (VCE)
Continuous Glucose Monitoring
Sports Performance lab
Flow Mediated Dilation and sonographers
Radio Opaque markers (WGTT)
Cognitive test batteries, sleep and mood
Cornometer, Tewameter and Visiometer
DXA Scans, MRI/X-ray
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SERVICES
Trial Design
Regulatory Expertise
Trial Conduct
Reporting
Participant Recruitment
Trial Analysis
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Clinical Endpoints
ENDPOINTS AND MEASUREMENTS
GASTROINTESTINAL HEALTH OBJECTIVE ENDPOINTS INDICATION MEASUREMENT Gut Functionality Function: oesophageal pH metry,
faecal weight and consistency; Transit time: radiopaque pellets; Permeability: lactulose-mannitol tracer test; Motility: gastric scintigraphy; VCE-Video Camera Endoscopy Epithelial integrity: histology, mucus secretion; Biomarkers: E-cadherin, growth factors, tight junction molecules, lipopolysaccharide (LPS) in blood, a-antitrypsin in faeces; Antimicrobial peptides: a-and b-defensins, calprotectin Immunoglobulins: IgA, IgE; Proteases: tryptase, chymase; Inflammatory cell signalling pathways: MAPK, NFkB, Cox 1 & 2; Inflammation: cytokines (Interleukins (IL) & TNFa), hsCRP, salivary cortisol, stool calprotectin
Gut Integrity
Immunity
/
Inflammation
Microbiota
Shotgun sequencing, functional genomics, metabolomics, transcriptomics, GA-Map.
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GASTROINTESTINAL HEALTH
SUBJECTIVE ENDPOINTS
INDICATION MEASUREMENT GI health
Bristol Stool Scale, Gastrointestinal Symptom Rating Scale (GSRS), IBS Severity Scoring System (IBS-SSS) Health Status Questionnaire (HSQ), Short Form Health Survey (SF)
Well-being
Dietary Analysis
FFQ, 24 hour recall, 3 day diary
BONE & JOINT HEALTH OBJECTIVE ENDPOINTS INDICATION MEASUREMENT Physical performance & functional capacity Hand grip strength (sarcopenia), knee extension & flexion measured by goniometry Bone mass and
Dual-emission X-ray absorptiometry (DEXA); osteoarthritis: X-RAY & Kellgren- Lawrence Gradient Scale interleukins (IL) -1B1, erythrocyte sedimentation rate (ESR), hsCRP, serum osteocalcin, serum hyaluronic acid (HA), serum keratin sulphate, transforming growth factor beta (TGF-B)
bone mineral density (BMD) Inflammatory markers
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BONE & JOINT HEALTH
SUBJECTIVE ENDPOINTS INDICATION MEASUREMENT Osteoarthritis: knee & joint pain, stiffness, symptoms, sport, recreation & physical function Western Ontario & McMaster
Universities Arthritis Index (WOMAC); Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain Intensity
Visual Analogue Scale (VAS); Numeric Rating Scale (NRS); Verbal Descriptive Scale (VDS); McGill Pain Questionnaire Short Physical Performance Battery (SPPB)
Physical Performance & functional capacity
Quality of Life
Short Form (SF) 36 questionnaire; daily or weekly We-diary
Dietary Analysis FFQ, 24 hour recall, 3 day diary
STRESS & COGNITIVE HEALTH OBJECTIVE ENDPOINTS
INDICATION MEASUREMENT Changes in biological stress indicators Salivary and plasma cortisol; IgA; tryptophan; heart rate
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STRESS & COGNITIVE HEALTH
SUBJECTIVE ENDPOINTS
INDICATION MEASUREMENT Cognitive Function Standardised cognitive test battery e.g.
Cambridge Neuropsychological Test Automated Battery (CANTAB); mini- mental state examination (MMSE) Age specific neurodevelopment tests
Cognitive development in children
Anxiety & Depression
Hamilton Anxiety Rating Scale (HAM-A); Beck depression inventory; Hamilton Depression Rating Scale (HAM-D); Trier social stress test (TSST)
Dietary Analysis
FFQ, 24 hour recall, 3 day diary
MICROBIOME HEALTH
MEASUREMENT Shotgun Metagenomic Sequencing, De Novo Sequencing of Genomes, Flow Cytometry & Fluorescence Activated Cell Sorting (FACS), 16S rRNA sequencing Metabolomics / Lipidomics, Proteomics, Fatty Acid / Bile Acid
Analysis, Transcriptomics, Functional Genomics Standard & Custom Library Generation, PCR Dietary Analysis: FFQ, 24 hour recall, 3 day diary
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CARDIOVASCULAR HEALTH
INDICATION MEASUREMENT Physical performance & functional capacity Exercise / daily activity log; Strength / endurance testing Abnormal Body Fat Distribution Body composition: DEXA; Adipose tissues biomarkers: leptin, adiponectin; Central fat: CT/MRI; Liver fat content: MRS; Weight Management: Dietician Insulin Resistance Elevated fasting glucose: oral glucose tolerance test (OGTT); postprandial insulin; Elevated free fatty acids; Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Hormonal Factors Leptin, ghrelin, cholecystokinin plasma, glucagon-like peptide (GLP) -1 growth hormones, cortisol Vascular Dysregulation Systolic/diastolic blood pressure (BP); Ambulatory BP; Endothelial function: flow mediated dilation (FMD); ACE inhibitor
Thrombosis
Fibrinolytic factors (Plasminogen activator inhibitor-1); Clotting factors (fibrinogen) Cholesterol: total, LDL, HDL; Apolipoprotein A1 & B, Omega 3 fatty acids EPA/DHA, conjugated linoleic acid
Atherogenic dyslipidaemia
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IMMUNE HEALTH
TECHNIQUE MEASUREMENT Flow Cytometry Cytokines: Interferons (IFN) e.g. IFN-g, Interleukins (IL) e.g. IL-1B, IL-6, IL-10, Tumour Necrosis Factors (TNF) Next Generation Sequencing Granulocytes: Neutrophils, Basophils, Eosinophis PCR Glucocorticoid: cortisol; Immunoglobulins (Ig) e.g. IgA, IgE Multiplexed Immunoassay Lymphocytes; T, B and Natural Killer (NK) cells, helper T cells, cytotoxic T cells
ELISA
High-sensitivity C-reactive protein (hsCRP)
Single Cell Analysis e.g. Proteomics
Monocytes / Macrophages
Dietary Analysis
FFQ, 24 hour recall, 3 day diary
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HEALTHY AGEING
INDICATION MEASUREMENT Cardiovascular function
Blood Pressure (BP); Ambulatory BP; Endothelial function e.g. flow-mediated dilation (FMD) GI transit; bowel function; dysphagia; microbiome diversity Hand grip strength; chair stand test; walking test; agility (chair seat and reach); 2 minute step test % lean muscle, bone density, DEXA scan; Measurements: resting heart rate, weight, muscle circumference Plasma essential and non-essential amino acids, total protein, albumin, serum and urinary urea; serum iron, transferrin saturation, iron binding capacity, ferritin levels; plasma and salivary cortisol, IgA, tryptophan, creatinine; glucose; serum triglyceride; omega-3 fatty acids; oxidative stress measurements Bristol Stool Scale, Gastrointestinal Symptom Rating Scale (GSRS), IBS Severity Scoring System (IBS-SSS) Health Status Questionnaire (HSQ), Short Form Health Survey (SF) FFQ, 24 hour recall, 3 day diary
Gastrointestinal function Physical Activity & performance Biometric & Anthropometric measurements Biological Sample indicators
GI function
Well-being
Dietary Analysis
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METABOLIC HEALTH
INDICATION MEASUREMENT Physical performance & functional capacity Body composition: DEXA or Tanita anthropometric measurements (waist circumference, calliper skin fold thickness, body composition analyser (bioimpedance); Adipose tissues biomarkers: leptin, adiponectin; Central fat: CT/MRI; Liver fat content: MRS; Weight Management: Dietician Insulin Resistance Elevated fasting glucose: oral glucose tolerance test (OGTT); postprandial insulin; Elevated free fatty acids; (HOMA-IR) Hormonal Factors Leptin, ghrelin, cholecystokinin plasma, glucagon-like peptide (GLP) -1 growth hormones, cortisol Vascular Dysregulation Exercise / daily activity log; Strength / endurance testing Abnormal Body Fat Distribution
Systolic/diastolic blood pressure (BP); Ambulatory BP; Endothelial function: flow mediated dilation (FMD); ACE inhibitor High sensitivity C-reactive protein (hsCRP); Cytokines: TNF alpha, interleukin-6; Bradykinin;
Inflammation
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METABOLIC HEALTH
INDICATION MEASUREMENT Thrombosis Fibrinolytic factors (Plasminogen activator inhibitor-1); Clotting factors (fibrinogen) Atherogenic dyslipidaemia Cholesterol: total, LDL, HDL; Apolipoprotein A1 & B, Omega 3 fatty acids EPA/DHA, conjugated linoleic acid
Appetite profile Dietary Analysis
Visual analogue scale (VAS)diary FFQ, 24 hour recall, 3 day diary
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PHYSICAL ACTIVITY & SPORTS HEALTH OBJECTIVE ENDPOINTS
INDICATION MEASUREMENT Cardiorespiratory capacity & Fitness
Cardiopulmonary Exercise Testing (CPET), respiratory oxygen uptake (VO2), carbon dioxide production (VCO2), maximal aerobic capacity (VO2max), anaerobic threshold, fat and carbohydrate metabolism, energy cost of exercise, resting metabolic rate can be assessed Pulmonary Function Tests (PFT) peak expiratory flow (PEF), forced vital capacity (FVP) and forced expiratory volume (FEV) using a spirometer Jumping repetition maximum weight lift (1RM), timed get up and go, chair stand, 6 min walking test, stair climb power test, gait speed, flexibility and range of motion, economy of motion, muscle fatigue, acceleration (accelerometer) height, 1 % lean muscle, bone density, using DEXA scan; Biometric & Anthropometric Measurements: resting heart rate, weight, muscle circumference
Lung Function
Physical Activity & Physical Performance
Body composition measurements
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PHYSICAL ACTIVITY & SPORTS HEALTH OBJECTIVE ENDPOINTS
INDICATION MEASUREMENT Muscle strength & endurance
Biodex Isokinetic Test measures isokinetic (both eccentric and concentric) function and isometric strength on major muscle groups, handgrip strength (arm curl with hand weight); Endurance Capacity: lactate threshold, multi-sprint endurance International Physical Activity Questionnaire (IPAQ)
Physical performance
Well-being
WHO 5 well being index
Dietary Analysis
FFQ, 24 hour recall, 3 day diary
SUBJECTIVE ENDPOINTS
INDICATION MEASUREMENT Physical performance International Physical Activity Questionnaire (IPAQ)
Well-being
WHO 5 well being index
Dietary Analysis
FFQ, 24 hour recall, 3 day diary
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NUTRITIONAL HEALTH OBJECTIVE ENDPOINTS INDICATION MEASUREMENT
Cardiovascular & Metabolic Health
Blood Pressure (BP); Ambulatory BP; Endothelial function e.g.FMD; Inflammatory biomarkers: interleukin-6, C-reactive protein; blood cholesterol: total, LDL, HDL Aerobic capacity/VO2 max, muscle mass / strength % lean muscle, bone density, using DEXA scan; Biometric & Anthropometric Measurements: resting heart rate, weight, muscle circumference Plasma essential and non-essential amino acid; plasma ketones; plasma creatine and urinary nitrogen; plasma glucose, insulin, serum triglycerides, serum and urinary urea, urinary ammonia, serum and urinary protein levels, metabolomics, lipidomics, proteomics
Physical Activity & performance Body composition measurements
Nutrient Analysis
Physical performance
International Physical Activity Questionnaire (IPAQ)
Well-being
WHO 5 well being index
Dietary Analysis
FFQ, 24 hour recall, 3 day diary
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WOMEN HEALTH OBJECTIVE ENDPOINTS
INDICATION MEASUREMENT Cardiovascular health Blood Pressure (BP); Ambulatory BP; Endothelial function e.g. flow- mediated dilation (FMD)
Gastrointestinal health Physical Activity & performance Body Composition measurements
GI transit; bowel function; microbiome diversity Aerobic capacity/VO2 max; muscle max/strength % lean muscle, bone density, DEXA scan; Measurements: resting heart rate, weight, muscle circumference Amsel’s criteria and Nugent scoring system used as diagnostic method and primary outcomes evaluation, reduction in episodes of VI (compared to placebo), Severity of VI symptoms, Duration of VI symptoms, Microbiological profiling (Vaginal Microbiome) inflammatory biomarkers; plasma essential and non-essential amino acids, total protein, albumin, serum and urinary urea; plasma and salivary cortisol, IgA, tryptophan (stress indicators), creatinine; glucose; serum triglyceride; omega-3 fatty acids; oxidative stress measurements
Vaginal infections (VI) follow up
Biological Sample indicators
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WOMEN HEALTH SUBJECTIVE ENDPOINTS
INDICATION MEASUREMENT GI health Physical Activity International Physical Activity Questionnaire (IPAQ) Anxiety & Sleep Quality Hamilton Anxiety Rating Scale (HAM-A) Well-being
Gastrointestinal Symptom Rating Scale (GSRS)
WHO 5 well being index, Quality of life using Assessment of Quality of Life (AQoL), 36-item short form (SF-36)
Dietary Analysis
FFQ, 24 hour recall, 3 day diary
Disclaimer
The previous tables are a description of Atlantia’s expertise, however they are not an exhaustive list of associated indications and measurements. Contact us to get a specific proposal depending on your investigational objectives, product, skin condition and desired population.
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Introduction and Product Areas
EXPERTS TO THE BEAUTY & PERSONAL CARE INDUSTRY
Atlantia has expertise in Skin Microbiome and Dermatology trials for cosmetics and consumer products, helping you to innovate in a competitive marketplace. Our team can design a trial based on your objectives, to investigate the safety and efficacy of new ingredients or final products, providing claim substantiation to support your product portfolio. Atlantia is a world class company in delivering clinical studies: we perform acute, observational and intervention studies to ICH- GCP & COLIPA standards for cosmetics, functional ingredients, supplements, pre- and probiotics. After having spun out of the world-renowned APC Microbiome Institute, we have developed a unique business model that combines very strong ties with the academic community, but operates as an independent contract research organisation (CRO) where the Intellectual Propertry belongs to the sponsor.
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Areas of Expertise
AREAS OF EXPERTISE
SKIN/FACE CARE: Efficacy Studies OBJECTIVE ENDPOINTS
TEST
MEASUREMENT
Anti-wrinkle/texture Wrinkles, fine lines, texture, pores, acne scars and volumes, selected in several zones of the face are analyzed using our Antera3D Firmness/Elasticity Our Cutometer® is used to measure viscoelastic properties of the skin Dark Spots/Age Spots Pigmentation, Vascular Lesions, Brown spots, hyper-pigmentation, rosacea, port wine stains can be measured using our Antera3D Skin Protection /Repair The skin protective barrier function
is assessed by measuring Trans- Epidermal Water Loss (TEWL) with our Tewameter® Skin surface pH can be measured using a Skin pH meter
Skin pH
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SKIN/FACE CARE: Efficacy Studies OBJECTIVE ENDPOINTS
TEST
MEASUREMENT
Skin brightening
Skin colour, phototype, ITA angles and colour differences can be measured using our Antera3D
Anti-Sebum/Sebum Control The sebum levels of the skin may be measured with our Sebumeter® Lip dryness/Lip Balm Lip dryness is evaluated by volunteers and graded by expert judges. In addition, the hydration of lips superficial layers may be measured with our Corneometer®. Hydrating/Moisturising Our Corneometer® measures the hydration on the superficial layers of the skin
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SKIN/FACE CARE: Efficacy Studies SUBJECTIVE ENDPOINTS
TEST
MEASUREMENT
Eczema
Eczema Area and Severity Index (EASI) Overall Dry Skin (Xerosis) Score (ODS): 5 point clinical assessment of skin dryness 5-Dimension (Degree, Duration, Direction, Disability & Distribution) Itch Scale
Skin dryness & presence of skin tears
Measure of pruritis
Self-reported measure of current mental wellbeing Clinical assessment of presence of skin tears Self-assessment of sleep quality
WHO-Five (WHO-5)
Well-being
Index
Skin Tear Audit Research (STAR) classification system
Richards-Campbell Questionnaire (RCSQ)
Sleep
Dietary Analysis
Dietary Analysis: FFQ, 3 day diary
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SKIN/FACE CARE: Microbiome Studies MICROBIOME ENDPOINTS
TEST
MEASUREMENT
Skin sampling techniques
Swabbing, tape stripping, D-squame sampling and punch biopsy Sequencing, Transcriptomics, Functional Genomics, Flow Cytometry, PCR
Profiling of Skin Microbiota
Profiling of Skin Lipids Lipidomics
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COSMETIC TESTING
TEST
MEASUREMENT
Foundation/Concealer Skin
tone evenness, mattifying effect, imperfection coverage and long-lasting product can be assessed color The appearance of the lips is analyzed to determine the glossy and the long-lasting effects of the product. In addition, the hydrating effect can be measured via the Standardized digital photographs are taken with the Antera 3D imaging system. A specialized software analyzes a zone of interest to evaluate skin tone evenness and skin color.
Lipstick
Self-Tanning
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HAIR CARE
TEST
MEASUREMENT
Anti-Sebum/Oily hair & scalp
The levels of sebum can be measured using the sebumeter
Anti-dandruff
Dryness, redness and itching sensations caused by dandruff can be assessed by clinical evaluation. Adherent Scalp Flaking Score (ASFS).
Disclaimer
The previous tables are a description of Atlantia’s expertise, however they are not an exhaustive list of associated indications and measurements. Contact us to get a specific proposal depending on your investigational objectives, product, skin condition and desired population.
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CLINICAL RESEARCH LIBRARY
QR CODE CASE STUDY
Assessing FMD in overweight adults
Digestive Discomfort Clinical Trial
Video Camera Endoscopy Clinical Trials
IBS Research & Probiotics
Sleep & Immunity Research
Probiotics
and
Weight
management
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LEARN MORE ABOUT OUR SKIN RESEARCH
On-Demand Webinar: Antimicrobial potential of the human skin microbiota
Join Dr. Julie O’Sullivan to understand her research on the area of skin microbiome and how to translate those advancements into final cosmetic products thanks to the validation through human clinical trials. What kind of biomarkers and other considerations to take on board.
Available through this link
Case Study: Assessing Trans-Epidermal Water Loss, Skin Hydration and
A Healthy skin is influenced by a complex interplay of many factors. This case study presents a clinical trial that aimed to assess the effect of an
oral supplement on some of these skin dimensions.
Available through this link
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OUR TEAM CAN GUIDE YOU Create the right study design to support your research program
REACH OUT TO OUR CLINICAL RESEARCH EXPERTS
sales@atlantiatrials.com
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