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The Effect of Almonds on Facial Aesthetics and Modulation of the Microbiome and Lipidome

6 juillet 2021 mis à jour par: University of California, Davis
The investigator hypothesizes that regular consumption of almonds will 1) improve the facial wrinkle severity in post-menopausal women, 2) improve the evenness of facial skin pigmentation, 3) diversify the gut microbiome and increase the short chain fatty acids in the blood, and 4) improve the skin barrier biophysical properties.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This study will be a 24 week supplementation study that utilizes two study groups: 1) control group and 2) almond supplementation: 20% energy intake. This will be a randomized, rater-blinded, and controlled study. There will be a total of 60 subjects, with 30 assigned to the control group and 30 assigned to almond supplementation.

Subjects will be recruited from the UC Davis Dermatology Clinic, UC Davis Main campus, California State University- Sacramento, and from the surrounding community physicians and the community in a 100 mile radius. The greater Sacramento area has a population of over 2 million to draw from and recruitment will be conducted through the use of Social Media and flyer based recruitment. Postmenopausal women have previous been recruited successfully in a previous study. The study visits will be performed at the UC Davis Dermatology Clinic located at 3301 C Street, Suite 1400, Sacramento, CA 95816.

Investigators will collect medical history and current medications from study participants- this is outlined in the HIPAA form. The two intervention groups will consist of those receiving almonds and those that are receiving a calorie matched snack. The almond dose will be provided as 20% of total energy (20% E) in the diet. This dose was selected based on a previous randomized trial examining lipid parameters in response to 0, 10%, and 20% E as dietary almonds and a recent meta-analysis of intervention trials of tree nuts [5, 6]. The control snack will be a typical western diet snack (see Table 1) . The calorie matched snacks are commercially available prepackaged snack items that will be purchased from Costco. Once a subject has met inclusion criteria and has signed IRB consent, anthropometric data will be obtained, 1-24 hour recall will be collected, training will be provided for recording dietary records, and estimated caloric needs will be calculated. Estimated energy needs (EER) will be determined using the Mifflin-St. Jeor equation and total daily energy needs (TDE) calculated as EER x activity factor of 1.3-1.5 for sedentary to average activity, or a higher activity level as indicated. A representative example of a 60 year old woman, 5'4", 140 pounds with typical activity level yields TDE of approximately 1,600 - 1,800 kcal/day, and 20% E of 320-360 kcal/day. The intervention and control snacks would be 56.7 g of almonds and 56.7 g pretzel + one-24 g chewy granola bar, respectively.

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • Sacramento, California, États-Unis, 95816
        • UC Davis Department of Dermatology, Clinical Trials Unit

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 100 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Postmenopausal women
  • Fitzpatrick skin types 1 and 2
  • Able to follow dietary intervention and attend all study visits

Exclusion Criteria:

  • Those with a nut allergy
  • Current smokers, those that have smoked within the past year, and former smokers with greater than a 20 pack-year history of smoking, as smoking is a independent risk factor and serves as a confounder for the development of facial wrinkles
  • Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos), as this can be a confounder for the development of facial wrinkles
  • Those that already obtain 20% of their energy intake from nut consumption
  • Those with implausible reported energy intakes of <1,000 kcal/d or >3,000 kcal/d
  • Individuals who are unwilling to discontinue vitamin E containing supplements and food sources during the washout and intervention

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Almond supplementation
The almond dose will be provided as 20% of total energy (20% E) in the diet. This dose was selected based on a previous randomized trial examining lipid parameters in response to 0, 10%, and 20% E as dietary almonds and a recent meta-analysis of intervention trials.
The almond dose will be provided as 20% of total energy (20% E) in the diet.
Aucune intervention: Control snack
The control snack will be a typical western diet snack. The calorie-matched control snack will be commercially available individually wrapped food products.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in wrinkle severity
Délai: 24 weeks
Photographs will be obtained at baseline, 8 weeks, 16 weeks, and 24 weeks. The images will be obtained with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) that has standardized positioning and lighting and iPad. The investigator has already validated this measurement tool against standard clinical grading of facial wrinkles.
24 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in facial pigmentation
Délai: 24 weeks
Photographs will be obtained at baseline, 8 weeks, 16 weeks, and 24 weeks. The images will be obtained with the 3D Clarity Pro® Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA) that has standardized positioning and lighting and iPad. This system can assess facial pigmentation evenness and average intensity. The investigator has already validated this measurement tool against standard clinical grading of facial pigmentation.
24 weeks
Change in appearance of facial wrinkles on lateral canthi
Délai: 24 weeks
Two blinded physician graders will grade the photographs obtained at each of the time points on the lateral canthi ("crow's feet").
24 weeks
Change in facial sebum production
Délai: 24 weeks
Change in facial sebum production through the use of a Sebumeter, a commonly used device that measures sebum excretion rate. Sebum excretion rate will be measured at baseline, 8 weeks, 16 weeks, and 24 weeks.
24 weeks
Change in the serum profile
Délai: 24 weeks
Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
24 weeks
Change in sebum lipid profile
Délai: 24 weeks
Change in the sebum lipid profile assessment of long chain/short chain fatty acid ratios and the NS ceramide content.
24 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 octobre 2018

Achèvement primaire (Réel)

1 juin 2021

Achèvement de l'étude (Réel)

22 juin 2021

Dates d'inscription aux études

Première soumission

30 octobre 2018

Première soumission répondant aux critères de contrôle qualité

31 octobre 2018

Première publication (Réel)

5 novembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 juillet 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 1257688

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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