Effect of Snacks on Aging

NCT06879626 | Recruiting

• 1 other identifier: IRB-25-0037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if daily consumption of 2 oz of pecans compared to 3.5 oz pretzel snacks for 12 weeks will 1) contribute to the body's ability to protect itself from oxidative damage (caused by oxygen radicals created by ultraviolet (UV) B light) by evaluating skin resistance to UV light irritation, skin fats/oils degradation and "rusting", and oxidative damage to the skin genes; and 2) explore the mechanisms of how snack consumption may affect aging by analyzing blood markers of aging as well as the microbes living in the gut (gut microbiome).

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Minimal Erythema Dose (MED)

  To determine the minimal erythema dose (MED) at the inner arm, skin UVB dose and treatment time will be determined based on overall skin type classification. Based on overall skin type classification we will use the National Biological UVB mJ chart to determine the dose and sequential exposure times for each skin patch. A sleeve with 6 cutout patches will be placed on participant's arm. Using the Dermalight 90 handheld device (National Biological, Beachwood, OH) each cutout test area on the inner arm of subjects will be exposed to a defined dose of narrow band ultraviolet B (NB-UVB) light delivered by the UV exposure between 270 and 400 nm. Each cutout window will be exposed to an increasing dose. To evaluate the minimal erythema dose (MED) participants will need to return 24 hours later to determine which skin patch showed minimal erythema (pink color). Although 6 cutouts will be made, this is a single outcome measure as the all 6 cutouts will all be measuring MED in mJ/cm\^2.

  At baseline and 12 weeks

Secondary Outcomes (4)

• Skin characteristics

  At baseline and 12 weeks

• Skin characteristics

  At baseline and 12 weeks

• Skin characteristics

  At baseline and 12 weeks

• Skin characteristics

  At baseline and 12 weeks

Other Outcomes (15)

• Biomarkers of aging and inflammation

  At baseline and 12 weeks

• Biomarkers of aging and inflammation

  At baseline and 12 weeks

• Biomarkers of aging and inflammation

  At baseline and 12 weeks

Study Arms (2)

Pecan arm

EXPERIMENTAL

Participats in this arm will be comsuming 2 oz of pecans daily for 12 wekks

Other: Pecan

Pretzel arm

EXPERIMENTAL

Participants in this arm will consume 3.5 oz of pretzel snacks daily for 12 weeks

Other: Pretzel

Interventions

Pecan OTHER

2 oz of whole raw pecans

Pecan arm

Pretzel OTHER

3.5 oz of pretzel snacks daily

Pretzel arm

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Generally healthy
• Aged 55-75 years
• BMI 18.5-34.9 kg/m2
• Fitzpatrick Skin type II-IV
• Consume a typical Western diet (low in polyphenols-rich foods and fiber)
• Willing to maintain habitual dietary and exercise patterns for the study duration
• Willing to maintain normal skin care products and pattern for the duration of the study
• Willing to come to study visits without any makeup and skin products on
• Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.

You may not qualify if:

• Vegetarian/vegan
• Known nut allergy
• Skin-related prescription medication, supplements or non-prescription cosmeceutical agents
• Initiation of topical or oral prescription steroids and/or anti-inflammatory medications within 30 days prior to study enrollment
• Excessive exposure to either natural or artificial sunlight
• Screening laboratory values outside of the normal range that is considered clinically significant for study participation by the investigator
• Documented chronic disease
• Taking medications or supplements known to affect gut microbiota composition (antibiotics within the past 3 months, probiotics, fiber, etc.)
• Taking exogenous hormones (e.g. hormone replacement therapy)
• Recent weight fluctuations (\>10% in the last 6 months)
• Smoker or living with a smoker
• Use of \>20 g of alcohol per day
• Unable or unwilling to comply with the study protocol (including unwillingness to avoid nuts for the whole duration of the study)
• Unable to provide consent
• Pregnancy and/or lactation

Sponsors & Collaborators

• University of California, Los Angeles: lead
• American Pecan Promotion Board: collaborator

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90095, United States

RECRUITING

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Diacova, PhD, RD

CONTACT

310-206-8292; tdiacova@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 17, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)