Skin AgeingPOMASKINNCT05842447
Effect of Pomanox® on Skin Ageing (POMASKIN)
A study testing 367 mg Pomanox group and 700 mg Pomanox group in people with Skin Ageing, run by Fundació Eurecat at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Ageing
- What is being tested?
- 367 mg Pomanox group and 700 mg Pomanox group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Oct 2023to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Two Doses of Pomanox® Pomegranate Extract Consumption on Skin Ageing. Randomized, Parallel, Placebo Controlled and Triple Blind Clinical Trial (POMASKIN).
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.
Read the 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).
- Conditions
- Skin Ageing
- Being tested
- 367 mg Pomanox group, 700 mg Pomanox group, Control group
- Keywords
- Photoageing, Polyphenols, Natural extracts, Collagen metabolism, Hyaluronic acid, Oxidative stress, Antiglycan effect, Inflammatory system, Intestinal microbiota, skin microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
367 mg Pomanox groupDietary supplement
Treatment with 367 mg Pomanox®P30 during 12 weeks
700 mg Pomanox groupDietary supplement
Treatment with 700 mg Pomanox®P30 during 12 weeks
Control groupDietary supplement
Treatment with maltodextrin during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 367 mg Pomanox group | Experimental | One capsule daily with 367 mg of Pomanox®P30 for 12 weeks Receives: Dietary Supplement: 367 mg Pomanox group |
| 700 mg Pomanox group | Experimental | One capsule daily with 700 mg of Pomanox®P30 for 12 weeks Receives: Dietary Supplement: 700 mg Pomanox group |
| Control group | Placebo comparator | One capsule daily with maltodextrin for 12 weeks Receives: Dietary Supplement: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin melanin index.
Skin melanin index measured by using a Mexameter® MX18.
Measured: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Secondary outcomes (37)
Change in skin wrinkles.
Skin wrinkles measured using a DermoPrime System.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in Human Procollagen I C-Terminal Propeptide blood levels.
Serum levels of Human Procollagen I C-Terminal Propeptide will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in Metalloproteinase-1 blood levels.
Serum levels of Metalloproteinase will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in hyaluronic acid blood levels.
Serum levels of hyaluronic acid will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in superoxide dismutase activity blood levels.
Serum superoxide dismutase activity will be measured using a colorimetric kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in reduced gluthathione blood levels.
Serum levels of reduced gluthathione will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in pentosidine blood levels.
Serum levels of pentosidine will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in carboxymethyl-lysine blood levels.
Serum levels of carboxymethyl-lysine will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in interleukin-1 alpha blood levels.
Serum levels of interleukin-1 alpha will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in interleukin-6 blood levels.
Serum levels of interleukin-6 will be measured using human ELISA kits.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in stool microbiota composition.
Total DNA extracted from stool samples will be sequenced on an Ion Torrent platform. It will be analysed the taxonomic profile, alpha diversity and beta diversity.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in skin microbiota composition.
Total DNA extracted from stool samples will be sequenced on an Ion Torrent platform. It will be analysed the taxonomic profile, alpha diversity and beta diversity.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in dimethylellagic acid glucuronide urine levels.
Urine levels of dimethylellagic acid glucuronide will be measured by Liquid Chromatography Mass Spectrometry.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Change in urolithin A glucuronide urine levels.
Urine levels of urolithin A glucuronide will be measured by Liquid Chromatography Mass Spectrometry.
Measured: At day 1 (visit V1) and day 85 (visit 3).
Subject self-assessment quality of the skin.
The quality of the skin of the volunteers will be evaluated subjectively through self-assessment questionnaire of the subjects themselves. This questionnaire will assess the perception of the volunteers on the improvement of their skin in general and on wrinkles, spots, redness, elasticity, hydration, pores and acne. In the questionnaire there will be 5 grades to asses the state: worsened (0), slightly worsened (1), no change (2), slightly improved (3) and improved (4).
Measured: At day 29 (visit V2) and day 85 (visit 3).
Age.
The age of the volunteers will be recorded in the case report form.
Measured: At day -7 (pre-selection visit).
Height.
Height measured by a standardized method.
Measured: At day -7 (pre-selection visit).
Change in body weight.
Body weight measured by a standardized method.
Measured: At day -7 (pre-selection visit), day 1 (visit V1, day 29 (visit 2) and day 85 (visit 3).
Change in body mass index.
Weight and height will be combined to report Body Mass Index in kg/m^2.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in fat mass.
Fat mass measured by TANITA SC 330.
Measured: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in muscle mass.
Muscle mass measured by TANITA SC 330.
Measured: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Concomitant medication.
Concomitant medication consumed during the study will be recorded in the case report form.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Dietary supplements consumed.
Dietary supplements consumed during the study will be recorded in the case report form.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Use of cosmetic treatments.
The use of cosmetic treatments during the study will be recorded in the case report form.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Exposure to ultraviolet radiation.
Exposure of volunteers to ultraviolet radiation will be recorded in the case report form.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Products with pomegranate and ellagitannins consumption.
Consumption of products with pomegranate and ellagitannins during the study will be recorded in the case report form.
Measured: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Eating habits.
Eating habits of volunteers during the study will be recorded using a food frequency questionnaire.
Measured: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Physical activity.
Physical activity of volunteers during the study will be recorded using the international physical activity questionnaire.
Measured: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Intervention compliance.
The intervention compliance by the volunteers will be assessed by counting the number of remaining capsules and applying the formula (Number of capsules consumed/Number of capsules to consume)x100.
Measured: At day 29 (visit 2) and day 85 (visit 3).
Adverse events.
Possible adverse events derived from taking study's products will be recorded in the case report form.
Measured: At day 29 (visit 2) and day 85 (visit 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start16 Oct 2023
- Primary completion5 Mar 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- Euromed, S.A.
- Responsible party
- Principal investigator, Antoni Caimari, Fundació Eurecat
- Investigators
- Antoni Caimari, PhD, Principal investigator, Fundació Eurecat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842447
- Sponsor's protocol ID
- POMASKIN
- Acronym
- POMASKIN
- Status last verified
- Oct 2024
- First submitted
- 24 Apr 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Doses of Pomanox® Pomegranate Extract Consumption on Skin Ageing. Randomized, Parallel, Placebo Controlled and Triple Blind Clinical Trial (POMASKIN).
- ClinicalTrials.gov ID
- NCT05842447
- Acronym / sponsor ID
- POMASKIN / POMASKIN
- Conditions
- Skin Ageing
- Keywords
- Photoageing, Polyphenols, Natural extracts, Collagen metabolism, Hyaluronic acid, Oxidative stress, Antiglycan effect, Inflammatory system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- Euromed, S.A.
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 367 mg Pomanox group | Experimental | Dietary Supplement: 367 mg Pomanox groupOne capsule daily with 367 mg of Pomanox®P30 for 12 weeks |
| 700 mg Pomanox group | Experimental | Dietary Supplement: 700 mg Pomanox groupOne capsule daily with 700 mg of Pomanox®P30 for 12 weeks |
| Control group | Placebo comparator | Dietary Supplement: Control groupOne capsule daily with maltodextrin for 12 weeks |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 367 mg Pomanox groupTreatment with 367 mg Pomanox®P30 during 12 weeks | Dietary supplement | 367 mg Pomanox group |
| 700 mg Pomanox groupTreatment with 700 mg Pomanox®P30 during 12 weeks | Dietary supplement | 700 mg Pomanox group |
| Control groupTreatment with maltodextrin during 12 weeks | Dietary supplement | Control group |
Primary outcome
Change in skin melanin index.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Skin melanin index measured by using a Mexameter® MX18.
37 secondary outcomes
Change in skin wrinkles.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in skin hydratation.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in skin elasticity.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in skin erythema index.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in skin pores.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in skin acne.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in skin keratin.
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.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in Human Procollagen I C-Terminal Propeptide blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in Metalloproteinase-1 blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in hyaluronic acid blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in superoxide dismutase activity blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in reduced gluthathione blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in pentosidine blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in carboxymethyl-lysine blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in interleukin-1 alpha blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in interleukin-6 blood levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in stool microbiota composition.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in skin microbiota composition.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in dimethylellagic acid glucuronide urine levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Change in urolithin A glucuronide urine levels.
Time frame: At day 1 (visit V1) and day 85 (visit 3).
Subject self-assessment quality of the skin.
Time frame: At day 29 (visit V2) and day 85 (visit 3).
Age.
Time frame: At day -7 (pre-selection visit).
Height.
Time frame: At day -7 (pre-selection visit).
Change in body weight.
Time frame: At day -7 (pre-selection visit), day 1 (visit V1, day 29 (visit 2) and day 85 (visit 3).
Change in body mass index.
Time frame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in fat mass.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Change in muscle mass.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Concomitant medication.
Time frame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Dietary supplements consumed.
Time frame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Use of cosmetic treatments.
Time frame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Exposure to ultraviolet radiation.
Time frame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Products with pomegranate and ellagitannins consumption.
Time frame: At day -7 (pre-selection visit), day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Eating habits.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Physical activity.
Time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).
Intervention compliance.
Time frame: At day 29 (visit 2) and day 85 (visit 3).
Adverse events.
Time frame: At day 29 (visit 2) and day 85 (visit 3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Caimari, PhD principal investigator
Fundació Eurecat
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 367 mg Pomanox group and 700 mg Pomanox group in people with Skin Ageing, run by Fundació Eurecat at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin melanin index. (time frame: At day 1 (visit V1), day 29 (visit 2) and day 85 (visit 3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.