Effect of Pomanox® on Skin Ageing (POMASKIN)

Fundació Eurecat66 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in skin melanin index.

Skin melanin index measured by using a Mexameter® MX18.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Secondary Outcomes

Change in skin wrinkles.

Skin wrinkles measured using a DermoPrime System.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Change in skin hydratation.

Skin hydratation measured using a DermoPrime System.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Change in skin elasticity.

Skin elasticity measured using a Cutometer ®MPA 580.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Change in skin erythema index.

Skin erythema index measured by using a Mexameter® MX18.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Change in skin pores.

Skin pores measured using a DermoPrime System.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Change in skin acne.

Skin acne measured using a DermoPrime System.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Change in skin keratin.

Skin keratin measured using a DermoPrime System.

Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).

Change in Human Procollagen I N-Terminal Propeptide blood levels.

Serum levels of Human Procollagen I N-Terminal Propeptide will be measured using human ELISA kits.