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RhytidesNCT02954315

The Effect of Almonds on Skin Lipids and Wrinkles

A study testing Almonds in people with Rhytides, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigators hypothesize that regular consumption of almonds will augment the long chain fatty acid profile and the alpha-tocopherol levels, improve the skin barrier function, and improve the appearance of facial wrinkles in post-menopausal women. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Rhytides
What is being tested?
Almonds
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
25 Oct 2016to 30 Apr 2018
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Those with a nut allergy
  • Smoking:
  • Current smokers
  • Those that have smoked within the past year
  • Former smokers with greater than a 20 pack-year history of smoking within the past 20 years will be excluded.
  • Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)
Show all 9Show fewer
  • 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 high antioxidant supplements and daily food sources listed below, during the washout and intervention.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UC Davis Department of Dermatology, Clinical Trials Unit

    Sacramento, California, 95816

Other trials in United States

About this study

Investigators hypothesize that regular consumption of almonds will augment the long chain fatty acid profile and the alpha-tocopherol levels, improve the skin barrier function, and improve the appearance of facial wrinkles in post-menopausal women.

Read the detailed description

Primary Endpoint:

  1. Change in wrinkle depth. Full facial photographs will be obtained at baseline, 8 weeks, and 16 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. This system can assess average wrinkle depth. The PI has already validated this measurement tool against standard clinical grading of facial wrinkles[13].

Secondary Endpoint:

  1. Change in clinical appearance of facial wrinkles on lateral canthi: Two blinded dermatologists will grade the photographs obtained at each of the time points on the lateral canthi ("crow's feet"). The dermatologists will not know which group the subjects were in.
  2. Change in facial sebum production through the use of a Sebumeter, a commonly used device that measures sebum excretion rate [13,17]. Sebum excretion rate will be measured at baseline, 8 weeks, and 16 weeks.
  3. Change in serum and sebum lipid profiles obtained through the use of Sebutapes at baseline, 8 weeks, and 16 weeks.
  4. Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content.

Procedures Involved This study will be a 16-week supplementation study that utilizes two study groups: 1) Control group 2) Almond supplementation: 20% energy intake. This will be a randomized, rater-blinded, controlled study.

There will be a total of 30 subjects:

Control Group: n=15 Almond Supplementation: n=15

The subjects will be recruited from the UC Davis Dermatology Department, the surrounding clinics in a 25 mile radius, and the general population in the Davis and Sacramento areas. 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.

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 [23,24]. The control snack will be a typical western diet snack. The calorie-matched control snack will be commercially available individually wrapped food products such as a small granola bar + pretzels. Once a subject has met inclusion criteria and has signed IRB consent, anthropometric data will be obtained, 3-24 hour recall will be collected by phone, skype, or in person by a Registered Dietitian, 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 dose of almonds would be 2 ounces (equal to 23 whole kernels)/day, providing 328 calories.

Conditions
Rhytides
Being tested
Almonds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlmondsOther

Study groups in NCT02954315
Study groupRoleWhat they receive
Almond armExperimentalThe 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.
Receives: Other: Almonds
Western diet Snack (Granola bar + Pretzels)No interventionThe control snack will be a typical western diet snack (see Table 1). The calorie-matched control snack will be commercially available individually wrapped food products such as a small granola bar + pretzels.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in wrinkle depth

    Measured: 16 weeks

Secondary outcomes (4)
  1. Change in clinical appearance of facial wrinkles on lateral canthi

    Measured: 16 weeks

  2. Change in facial sebum production through the use of a Sebumeter

    Measured: 16 weeks

  3. Change in serum and sebum lipid profiles

    Measured: 16 weeks

  4. Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content

    Measured: 16-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2016 (estimated)
  2. Study start25 Oct 2016
  3. Primary completion30 Apr 2018
  4. Study completion30 Apr 2018

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02954315
Sponsor's protocol ID
930524
Status last verified
Oct 2018
First submitted
1 Nov 2016
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Alasalvar C, Bolling BW. Review of nut phytochemicals, fat-soluble bioactives, antioxidant components and health effects. Br J Nutr. 2015 Apr;113 Suppl 2:S68-78. doi: 10.1017/S0007114514003729.

    PubMed 26148924

Questions about this trial

What is this clinical trial studying?

A study testing Almonds in people with Rhytides, run by University of California, Davis at 1 site in United States.

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 3 inclusion and 9 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 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 wrinkle depth (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02954315, which also lists 1 linked publication.

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 17 Oct 2018.

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