Collagen DegenerationNCT06074276
The Effects of Almond on Facial Skin Collagen and Wrinkles
A study testing Food: whole almonds and Food: non-nut snack in people with Collagen Degeneration and Wrinkle, run by Integrative Skin Science and Research at 1 site in United States.
Trial summary
Investigate the effects of almond consumption on collagen production, elastin levels, wrinkles, and pigmentation among premenopausal women and postmenopausal women belonging to all Fitzpatrick skin types. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Collagen Degeneration, Wrinkle, Pigmentation
- What is being tested?
- Food: whole almonds and Food: non-nut snack
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 31 Dec 2024
- 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 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 35 to 70 years of age of all skin types
- 50% of the subjects will be postmenopausal women determined as >1-year loss of menstrual period
- 50% of the subjects will be premenopausal women
- BMI 18.5 - 35 kg/m2
- Individuals with a habitual diet that has been maintained for at least 6 months and to be maintained for the duration of the study
- Individuals must maintain their usual skincare products, defined as products that has been used for at least 1 month, for the duration of the study
Who cannot join
- Those with a nut allergy
- Those who are unwilling to discontinue oral collagen supplementation 1 month prior to the start of the study
- Individuals who are unwilling to discontinue vitamin E or nut containing supplements 2 weeks prior to and during the intervention.
- Individuals who are pregnant or breastfeeding
- Change in skincare products during the study
- Had a medical or cosmetic procedure such as laser resurfacing or plastic surgery to the face within the last 6 months (include botulinum toxin, dermal fillers, collagen, or other similar cosmetic procedure)
Show all 9Show fewer
- Has an autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as Ehler-Danlos)
- Those with a skin disease on their face that would affect the assessment of their skin based on the assessment of the investigator.
- Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrative Skin Science and Research
Sacramento, California, 95819
Nasima Afzal, 916-750-2463, nasima@integrativeskinresearch.com
About this study
Official title: Prospective Randomized Controlled Trial on the Effects of Almond on Facial Skin Collagen and Wrinkles
Investigate the effects of almond consumption on collagen production, elastin levels, wrinkles, and pigmentation among premenopausal women and postmenopausal women belonging to all Fitzpatrick skin types.
Read the detailed description
Almonds are energy-dense and rich in beneficial nutrients including B vitamins, vitamin E, mono- and polyunsaturated fatty acids, protein, fiber, minerals and polyphenols. Polyphenols and vitamin E in almonds provide protection to the body in part, through their ability to combat oxidative stress. Clinical studies have demonstrated beneficial effects of almond consumption on diseases such as diabetes and cardiovascular disease.
Almond consumption has been shown to significantly decrease wrinkle severity in two clinical studies conducted with postmenopausal women with Fitzpatrick skin type I and II. Almond intake has also been shown to increase resistance to erythema induced by ultraviolet exposure. The extracellular matrix contains proteins including collagen and elastin, which contributes to the integrity of the skin. Enzymatic and ultraviolet radiation induced degradation and a reduction in synthesis of collagen and elastin contribute to wrinkle formation. Furthermore, the process of menopause decreases the level of estrogen which affects the skin in several ways, including a decrease in skin collagen and hydration, and an increase in wrinkling.
- Conditions
- Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin
- Being tested
- Food: whole almonds, Food: non-nut snack
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food: whole almondsOther
60 grams or (~2 oz) will be consumed 5 times per week.
Food: non-nut snackOther
Protein and calorie matched non-nut-based food will be consumed 5 times per week by mouth
| Study group | Role | What they receive |
|---|---|---|
| Almonds | Experimental | Consumption of almonds 5 times per week Receives: Other: Food: whole almonds |
| Control Snack | Placebo comparator | Consumption of protein and calorie matched non-nut-based food 5 times per week Receives: Other: Food: non-nut snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin collagen and elastin quantification
Assess with biopsy based histological examination
Measured: 24 weeks
Facial wrinkles
Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.
Measured: 24 weeks
Secondary outcomes (6)
Pigment intensity score
Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Higher scores indicate darker pigmentation.
Measured: 12 Weeks
Pigment intensity score
Change in the appearance of facial pigmentation by high resolution photography (BTBP Clarity Pro) and measures intensity of facial pigmentation. Higher scores indicate darker pigmentation.
Measured: 24 Weeks
Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies
Assess through biopsy based histological examination
Measured: 24 Weeks
Plasma for potential AGE (advanced glycation end products) analysis
Blood samples will be collected
Measured: 12 Weeks
Plasma for potential AGE (advanced glycation end products) analysis
Blood samples will be collected
Measured: 24 Weeks
Facial Wrinkles
Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start4 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen DegenerationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrative Skin Science and Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raja Sivamani, MD MS AP, Principal investigator, Integrative Skin Science and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074276
- Sponsor's protocol ID
- i23-07_Almond_Collagen
- Status last verified
- Jun 2024
- First submitted
- 3 Oct 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial on the Effects of Almond on Facial Skin Collagen and Wrinkles
- ClinicalTrials.gov ID
- NCT06074276
- Acronym / sponsor ID
- i23-07_Almond_Collagen
- Conditions
- Collagen Degeneration, Wrinkle, Pigmentation, Elastic Skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Integrative Skin Science and ResearchIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- 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.
Investigate the effects of almond consumption on collagen production, elastin levels, wrinkles, and pigmentation among premenopausal women and postmenopausal women belonging to all Fitzpatrick skin types.
Detailed description
Almonds are energy-dense and rich in beneficial nutrients including B vitamins, vitamin E, mono- and polyunsaturated fatty acids, protein, fiber, minerals and polyphenols. Polyphenols and vitamin E in almonds provide protection to the body in part, through their ability to combat oxidative stress. Clinical studies have demonstrated beneficial effects of almond consumption on diseases such as diabetes and cardiovascular disease.
Almond consumption has been shown to significantly decrease wrinkle severity in two clinical studies conducted with postmenopausal women with Fitzpatrick skin type I and II. Almond intake has also been shown to increase resistance to erythema induced by ultraviolet exposure. The extracellular matrix contains proteins including collagen and elastin, which contributes to the integrity of the skin. Enzymatic and ultraviolet radiation induced degradation and a reduction in synthesis of collagen and elastin contribute to wrinkle formation. Furthermore, the process of menopause decreases the level of estrogen which affects the skin in several ways, including a decrease in skin collagen and hydration, and an increase in wrinkling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almonds | Experimental | Other: Food: whole almondsConsumption of almonds 5 times per week |
| Control Snack | Placebo comparator | Other: Food: non-nut snackConsumption of protein and calorie matched non-nut-based food 5 times per week |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects 35 to 70 years of age of all skin types
- 50% of the subjects will be postmenopausal women determined as >1-year loss of menstrual period
- 50% of the subjects will be premenopausal women
- BMI 18.5 - 35 kg/m2
- Individuals with a habitual diet that has been maintained for at least 6 months and to be maintained for the duration of the study
Key exclusion criteria (9 listed)
- Those with a nut allergy
- Those who are unwilling to discontinue oral collagen supplementation 1 month prior to the start of the study
- Individuals who are unwilling to discontinue vitamin E or nut containing supplements 2 weeks prior to and during the intervention.
- Individuals who are pregnant or breastfeeding
- Change in skincare products during the study
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 |
|---|---|---|
| Food: whole almonds60 grams or (~2 oz) will be consumed 5 times per week. | Other | Almonds |
| Food: non-nut snackProtein and calorie matched non-nut-based food will be consumed 5 times per week by mouth | Other | Control Snack |
Primary outcome
Skin collagen and elastin quantification
Time frame: 24 weeks
Assess with biopsy based histological examination
Facial wrinkles
Time frame: 24 weeks
Wrinkle severity score measured by Facial Image Analysis System (BTBP 3D image analysis system). Higher scores indicate worsened wrinkle severity and lower scores represent improvement in wrinkle severity.
6 secondary outcomes
Pigment intensity score
Time frame: 12 Weeks
Pigment intensity score
Time frame: 24 Weeks
Expression of enzymes that either degrade collagen (MMP1) or inhibit collagen degradation (TIMP1) on skin biopsies
Time frame: 24 Weeks
Plasma for potential AGE (advanced glycation end products) analysis
Time frame: 12 Weeks
Plasma for potential AGE (advanced glycation end products) analysis
Time frame: 24 Weeks
Facial Wrinkles
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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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 Sivamani, MD MS AP principal investigator
Integrative Skin Science and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food: whole almonds and Food: non-nut snack in people with Collagen Degeneration and Wrinkle, run by Integrative Skin Science and Research 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 6 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Adnan (9168074299, sarah@integrativeskinresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin collagen and elastin quantification (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2024.