Effect of Snacks on Aging
Effect of Pecan Consumption on Aging
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Tatiana Diacova, PhD, RD
- Phone Number: 310-206-8292
- Email: tdiacova@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA Center for Human Nutrition
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Pecan arm
Participats in this arm will be comsuming 2 oz of pecans daily for 12 wekks
|
2 oz of whole raw pecans
|
|
Experimental: Pretzel arm
Participants in this arm will consume 3.5 oz of pretzel snacks daily for 12 weeks
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3.5 oz of pretzel snacks daily
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minimal Erythema Dose (MED)
Time Frame: At baseline and 12 weeks
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin characteristics
Time Frame: At baseline and 12 weeks
|
skin elasticity (Cutometer Dual MPA 580) in N/m
|
At baseline and 12 weeks
|
|
Skin characteristics
Time Frame: At baseline and 12 weeks
|
hydration (Corneometer CM 825) in AU
|
At baseline and 12 weeks
|
|
Skin characteristics
Time Frame: At baseline and 12 weeks
|
color (Mexameter MX18) in AU
|
At baseline and 12 weeks
|
|
Skin characteristics
Time Frame: At baseline and 12 weeks
|
skin gloss (SkinGlossymeter GL200) in GU
|
At baseline and 12 weeks
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
C-C motif chemokine 27 (CTACK/CCL27) in pg/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
fibroblast growth factor 21 (FGF-21) in pg/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
growth/differentiation factor 11 (GDF-11) in ng/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
growth/differentiation factor 15 (GDF-15) in pg/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
gonadoliberin (GnRH) in pg/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
interleukin-6 (IL-6) in pg/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
interleukin-10 (IL-10) in pg/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
interleukin-18 (IL-18) in pg/ml
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
Jagged 1 protein (Jag1) in kDA
|
At baseline and 12 weeks
|
|
Biomarkers of aging and inflammation
Time Frame: At baseline and 12 weeks
|
leptin in ng/ml
|
At baseline and 12 weeks
|
|
Oxidative stress markers
Time Frame: At baseline and 12 weeks
|
Urine malondialdehyde (MDA) in ng/ml
|
At baseline and 12 weeks
|
|
Oxidative stress markers
Time Frame: At baseline and 12 weeks
|
Blood MDA in nmol/ml
|
At baseline and 12 weeks
|
|
Oxidative stress markers
Time Frame: At baseline and 12 weeks
|
Urine 8OHdG in ng/mg creatinine
|
At baseline and 12 weeks
|
|
Oxidative stress markers
Time Frame: At baseline and 12 weeks
|
Blood 8OHdG in ng/ml
|
At baseline and 12 weeks
|
|
Gut microbiome
Time Frame: At baseline and 12 weeks
|
The stool specimen will be collected by the participants at home at baseline and week 12 utilizing our Stool Collection Kit as per instructions.
Immediately after collection, the specimen will be frozen in a home freezer and delivered in an insulated container to the UCLA Center for Human Nutrition.
At UCLA, the specimen will be stored at - 80 ºC.
Fecal microbiological analyses.
Approximately 1g of the stool will be weighed and dried in a vacuum drying oven (15 in Hg) at 80 ºC for 48 hours, then weighed again to establish the moisture content so that all counts can be corrected to dry weight.
From another aliquot of remaining fecal samples, DNA will be extracted using bead beating with a commercial extraction system (DNeasy PowerSoil® DNA Isolation Kit, Qiagen, Valencia, CA).
The quality of the DNA samples will be confirmed using a Nanodrop 1000 (Thermo Fisher Scientific, Wilmington, DE).
Extracted DNA will be transferred to UCLA Microbiome Core facility for MiSeq sequencing.
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At baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Zhaoping Li, MD, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- IRB-25-0037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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