NCT06059534

Brief Summary

The goal of this clinical trial is to study the effects of DracoBelleTM Nu in different skin parameters associated with age. Volunteers will be asked to take either placebo of DracoBelleTM Nu capsules once a day by oral intake for a total period of 12 weeks. Several age-associated skin parameters (skin elasticity, firmness, fatigue, wrinkles, roughness, skin density, hydration, pigmentation and barrier effect) will be measured before the treatment and 4, 8 and 12 weeks after the first oral intake. Data of the placebo and DracoBelleTM Nu group will be analyzed to evaluate the effect of the product DracoBelleTM Nu in the selected age-associated skin parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

August 17, 2023

Last Update Submit

January 17, 2024

Conditions

Healthy Volunteers

Keywords

DracoBelleTM NuSkinAgingOralIngestionNutraceuticalWrinklesElasticityFirmnessBarrier effectHydrationDensityDragonheadPlaceboRoughnessFatiguePigmentationRandomizedBlinded

Outcome Measures

Primary Outcomes (9)

  • Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin elasticity will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.

    Skin elasticity will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin firmness will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.

    Skin firmness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin fatigue will be measured in the face skin area with the Cutometer, and the unit of measurement will be arbitrary units.

    Skin fatigue will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Wrinkles will be measured in the crows feet area with the Bio3D-MS, and the unit of measurement will be arbitrary units.

    Wrinkles will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Roughness will be measured in the crows feet area with the Bio3D-MS, and the unit of measurement will be arbitrary units.

    Roughness will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Skin density will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin density will be measured in the face skin area with the UltraScan Echograph, and the unit of measurement will be arbitrary units.

    Skin density will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Skin hydration will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin hydration will be measured in the face skin area with the Corneometer, and the unit of measurement will be arbitrary units.

    Skin hydration will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Skin barrier effect will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin barrier effect will be measured in the face skin area with the Tewameter, and the unit of measurement will be arbitrary units.

    Skin barrier effect will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

  • Skin pigmentation will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake.

    50 volunteers will ingest the placebo and 50 volunteers will ingest the product DracoBelleTM Nu by oral intake once a day (one capsule a day) for 12 weeks. Skin pigmentation will be measured in the face skin area with the Bio3D-MS, and the unit of measurement will be arbitrary units.

    Skin pigmentation will be measured before treatment (D0) and at week 4, week 8, and week 12 after the first oral intake of the product.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

This group will be provided with placebo capsules for comparative purposes.

Dietary Supplement: Dietary supplementation with placebo.

DracoBelleTM Nu

EXPERIMENTAL

This group will be provided with DracoBelleTM Nu capsules, which will be compared to the placebo group.

Dietary Supplement: Dietary supplementation with DracoBelleTM Nu.

Interventions

Dietary supplementation with placebo.DIETARY_SUPPLEMENT

Volunteers will be provided with the placebo capsules. For each volunteer, different age-associated skin parameters will be measured with specialized equipment before the treatment and 4, 8 and 12 weeks after the first oral intake of the product.

Placebo
Dietary supplementation with DracoBelleTM Nu.DIETARY_SUPPLEMENT

Volunteers will be provided with the DracoBelleTM Nu capsules. For each volunteer, different age-associated skin parameters will be measured with specialized equipment before the treatment and 4, 8 and 12 weeks after the first oral intake of the product.

DracoBelleTM Nu

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female volunteers.
  • Between 35-60 years old (both included).
  • With noticeable wrinkles.
  • Subjects with absence of any infectious disease within the 4 weeks previous to the study.
  • Informed of the purpose and the protocol of the study and signed a written informed-consent form.

You may not qualify if:

  • Diagnosis of any diseases such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease.
  • Consume more than the recommended alcohol guidelines i.e. \>21 alcohol units/week for males and \>14 units/week for females (europa.eu).
  • Current smoking habit or history of smoking within the past 1 year.
  • History of depression, schizophrenia, alcoholism, drug addiction, or mental illness.
  • Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
  • History of asthma or autoimmune disease Use of oral hormone therapies ie. cortisone or steroids in the 6 months prior to initiation of the study.
  • Abnormal liver function or abnormal renal function.
  • Blood pressure \>140/90 mmHg or hypertension with intake of a diuretic.
  • Any condition judged by the investigator to be unsuitable for participation in the study.
  • Subjects refrain from the intake of other oral supplements, including antioxidants, dietary supplements, etc.
  • Subjects do not alter their mode of contraception 6 weeks prior and during the study.
  • Subjects refrain from any intense or invasive cosmetic treatment, alone or by a beautician, such as intense masks, peelings, and other treatments.
  • Subjects are free to follow their usual routine of day and night care products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bionos Biotech S.L.

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Fatigue

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • David Pajuelo Gamez, PhD

    Hospital La Fe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

September 28, 2023

Study Start

October 19, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)