Clinical trial NCT05842447: Effect of Pomanox® on Skin Ageing (POMASKIN)
Official title: Effect of Two Doses of Pomanox® Pomegranate Extract Consumption on Skin Ageing. Randomized, Parallel, Placebo Controlled and Triple Blind Clinical Trial (POMASKIN).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Ageing
Keywords: Photoageing
Polyphenols
Natural extracts
Collagen metabolism
Hyaluronic acid
Oxidative stress
Antiglycan effect
Inflammatory system
Intestinal microbiota
skin microbiota
Lead sponsor: Fundació Eurecat
Sponsor class: OTHER
Collaborators: name: Euromed, S.A.
First posted: 2023-05-06
Enrollment: 66
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The state of skin health impacts not only on the general health of individuals, but also on mental health. Ultraviolet radiation (UV) is one of the main external factors that causes skin ageing, producing photo-aging, characterized by multiple alterations in the skin such as the appearance of wrinkles, dryness, erythema, alterations in the pigmentation, inflammation and increased fragility.

Several studies show that polyphenols extracts, including pomegranate extracts, have beneficial effects on various skin characteristics induced by photoaging by modulating internal factors that lead to changes associated with photoaging. Among these internal factors are oxidative stress, glycation stress caused by an accumulation of advances glycation end-products (AGEs), inflammation, and the composition of the intestinal and skin microbiota.

Pomanox® is a polyphenolic extract derived from pomegranate for which antioxidant activity and positive effects on the metabolism of collagen and hyaluronic acid have been shown in previous in vitro studies.

Detailed description: The hypothesis of the study is that the consumption of Pomanox®P30 will have beneficial effects on skin ageing in humans through the modulation of the metabolism of collagen, hyaluronic acid and the inflammatory system, the inhibition of the production of reactive oxygen species and AGEs, and/or changes in the intestinal and skin microbiota composition.

The main objective of the study is to evaluate the effect of consuming two doses of Pomanox®P30 on hyperpigmented skin spots in humans.

The secondary objectives of the study are to evaluate the effects of consuming two doses of Pomanox®P30 on other parameters related to skin ageing (wrinkles, elasticity, erythema index, hydration, pores, acne and keratin), on different markers of collagen and hyaluronic acid metabolism, oxidative stress, the anti-glycan effect and the inflammatory system, and on the composition of the intestinal and skin microbiota.

A randomized, parallel, placebo-controlled, single-center, triple-blind clinical trial with a 1:1:1 ratio between interventions with 66 participants will be conducted.

Each participant will make 4 visits:

* A pre-selection visit (to check inclusion/exclusion criteria) (V0), and if the eligibility criteria are met,
* 3 study visits during the consumption of the treatments, which will take place on the first day of the study (V1), at 29 days of treatment (V2) and at 85 days of treatment (V3).

Eligibility criteria: Inclusion Criteria:

* Women aged 30 years or older and 65 years or less.
* Fitzpatrick skin phototype II-IV.
* Read, write and speak Catalan or Spanish.
* Sign the informed consent.

Exclusion Criteria:

* Present any chronic gastrointestinal disease that may interfere with the objectives of the study such as celiac disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome with symptoms in the last 6 months, chronic diarrhea, or having undergone any bariatric surgery procedure.
* Present a chronic disease with clinical manifestation and/or being under pharmacological treatment that may interfere with participation in the study.
* Present values of body mass index ≥ 35 kg/m\^2.
* Present a clinical history of active anemia.
* Have consumed or intended to consume during the study treatments, supplements or multivitamin supplements or phytotherapeutic products that interfere with the study treatment (such as retinol or vitamin A, vitamin C, vitamin E, antioxidants, polyphenols, probiotics and prebiotics) up to 30 days before the start of the study intervention.
* Have consumed or intended to consume during the study contraceptive treatments or hormonal therapy up to 30 days before the start of the study intervention.
* Have taken treatment with antibiotics up to 30 days before the start of the study intervention.
* Have taken or intended to take treatments for acne, for photo-ageing or to improve the appearance or condition of the skin (such as chemical peeling, laser therapy, light therapy or hyaluronic acid injection; regular treatment in a facial beauty salon, skin whitening agents) up to 6 months before the start of the study intervention.
* Being a smoker or ex-smoker in the last 6 months before inclusion in the study.
* Consume 2 o more Standard Beverage Units daily or 17 weekly.
* Present allergy and/or intolerance to the study products (such as presenting hypersensitivity to maltodextrin or allergy to pomegranate).
* Being pregnant or intending to become pregnant.
* Being in breastfeeding period.
* Being participating, intending to participate or having participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
* Present any skin disease (such as atopic skin, eczema, neurodermatitis, vitiligo or psoriasis) or any skin disorder in the sudy area (such as irritations, moles, scars or macules).
* Have been intensely exposed to the sun or artificial ultraviolet radiations (solarium) in the test area during the 30 days before the start of the study or planning to do so during the study.
* Not being able to follow the guidelines of the study.

Primary outcomes:
measure: Change in skin melanin index.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Secondary outcomes:
measure: Change in skin wrinkles.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in skin hydratation.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in skin elasticity.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in skin erythema index.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in skin pores.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in skin acne.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in skin keratin.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in Human Procollagen I N-Terminal Propeptide blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in Human Procollagen I C-Terminal Propeptide blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in Metalloproteinase-1 blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in hyaluronic acid blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in superoxide dismutase activity blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in reduced gluthathione blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in pentosidine blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in carboxymethyl-lysine blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in interleukin-1 alpha blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in interleukin-6 blood levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in stool microbiota composition.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in skin microbiota composition.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in dimethylellagic acid glucuronide urine levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Change in urolithin A glucuronide urine levels.
timeFrame: At day 1 (visit V1) and day 85 (visit 3).
measure: Subject self-assessment quality of the skin.
timeFrame: At day 29 (visit V2) and day 85 (visit 3).
measure: Age.
timeFrame: At day -7 (pre-selection visit).
measure: Height.
timeFrame: At day -7 (pre-selection visit).
measure: Change in body weight.
timeFrame: At day -7 (pre-selection visit), day 1 (visit V1, day 29 (visit 2) and day 85 (visit 3).
measure: Change in body mass index.
timeFrame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in fat mass.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Change in muscle mass.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Concomitant medication.
timeFrame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Dietary supplements consumed.
timeFrame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Use of cosmetic treatments.
timeFrame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Exposure to ultraviolet radiation.
timeFrame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Products with pomegranate and ellagitannins consumption.
timeFrame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Eating habits.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Physical activity.
timeFrame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
measure: Intervention compliance.
timeFrame: At day 29 (visit 2) and day 85 (visit 3).
measure: Adverse events.
timeFrame: At day 29 (visit 2) and day 85 (visit 3).
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Anna Crescenti
state: Catalonia. Spain
city: Reus
country: Spain
facility: Eurecat
Study officials:
affiliation: Fundació Eurecat
name: Antoni Caimari, PhD
role: PRINCIPAL_INVESTIGATOR
References: