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.
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
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:
- 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:
- 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.
- 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.
- Change in serum and sebum lipid profiles obtained through the use of Sebutapes at baseline, 8 weeks, and 16 weeks.
- 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 group | Role | What they receive |
|---|---|---|
| Almond arm | Experimental | 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. Receives: Other: Almonds |
| Western diet Snack (Granola bar + Pretzels) | No intervention | The 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.
Change in wrinkle depth
Measured: 16 weeks
Secondary outcomes (4)
Change in clinical appearance of facial wrinkles on lateral canthi
Measured: 16 weeks
Change in facial sebum production through the use of a Sebumeter
Measured: 16 weeks
Change in serum and sebum lipid profiles
Measured: 16 weeks
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.
- First posted3 Nov 2016 (estimated)
- Study start25 Oct 2016
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhytidesStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raja K Sivamani, M.D., Principal investigator, UC Davis
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Almonds on Skin Lipids and Wrinkles
- ClinicalTrials.gov ID
- NCT02954315
- Acronym / sponsor ID
- 930524
- Conditions
- Rhytides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Endpoint:
- 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:
- 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.
- 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.
- Change in serum and sebum lipid profiles obtained through the use of Sebutapes at baseline, 8 weeks, and 16 weeks.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almond arm | Experimental | Other: AlmondsThe 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. |
| Western diet Snack (Granola bar + Pretzels) | No intervention | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women
- Fitzpatrick skin types 1 and 2
- Able to follow dietary intervention and attend all study visits
Key exclusion criteria (9 listed)
- Those with a nut allergy
- Smoking:
- Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almonds | Other | Almond arm |
Primary outcome
Change in wrinkle depth
Time frame: 16 weeks
4 secondary outcomes
Change in clinical appearance of facial wrinkles on lateral canthi
Time frame: 16 weeks
Change in facial sebum production through the use of a Sebumeter
Time frame: 16 weeks
Change in serum and sebum lipid profiles
Time frame: 16 weeks
Change in the serum and sebum lipid profile for assessment of long chain/short chain fatty acid ratios and the NS ceramide content
Time frame: 16-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 26148924Alasalvar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raja K Sivamani, M.D. principal investigator
UC Davis
1 site in 1 country: see every site and its status.
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.