Plain English Summary
Background and study aims
Acne vulgaris is a common skin condition which causes spots to develop on the skin, usually the face, chest and back. Some cases of acne can cause large lesions (pustules) that can leave scars. It is the most common skin disease that is treated by physicians. Although it is easy to diagnose, the nature of acne vulgaris means that there is no one simple way to evaluate its severity. Acne is no longer considered a teenager problem as it can affect men and women of all ages.
Some of the underlying causes are excessive sebum (oils), bacteria, hormones, stress and diet. A very important factor that causes acne is inflammation (swelling). Research has shown that the influence of diet on the development of acne could be associated to inflammation. The typical treatments for acne are usually topical medications (creams and gels that are applied to the body), ultraviolet radiation (shining a specific light directly on the skin) and oral (taken by mouth) medications. In additional to traditional therapies, many natural remedies have been made to act directly on the disorder and are antioxidant, restorative and anti-inflammatory. The underlying processes are complex but they show that inflammatory action could be stopped as there are specific enzymes that transform fatty acids (mainly omega 3 and 6) into compounds able to stop the inflammatory process. Studies have shown that omega-3 fatty acids play a major role in anti-inflammatory processes even more than omega-6 acids, therefore there should be an increase of omega-3 intake in diets. The ideal ratio of omega-3 and omega-6 fatty acids suggested for diets is 1.8:1. However, Western diets really lack fatty acids as they food eaten does not contain a high amount of them. Chia seeds (small brown/black seeds found in Mexico and Guatemala) are naturally rich in parent omega 3 (alpha-linolenic acid) and therefore have the potential to help treat inflammatory disorders. The aim of this study is to evaluate the effects of a nutraceutical product made with chia seeds on acne lesions.
Who can participate?
Adults between the ages of 18-65 with chronic acne.
What does the study involve?
All participants fill out a food frequency questionnaire at the beginning of the study and then are asked to consume a food containing no omega 3 or omega 6 every day for a month. They are then randomly allocated to one of five groups. Those in group one eat five grams of chia seeds daily for two months. Those in group two eat five grams of micronized chia seeds daily for two months. Those in group three eat two grams of a food product that has monocomponent chia seeds daily for two months. Those in group four eat two grams of a food product that has multicomponent chia seeds daily for two months. Those in group five eat 60mg of vitamin E daily for two months. Participants are asked to fast for 12 hours before they give blood samples at the beginning of the study and at week four, eight, 12 and 16. Participants are followed up to see how the chia seeds affect their acne lesions.
What are the possible benefits and risks of participating?
Participants may benefit from a reduction in acne lesions. There are no notable risks involved with participating.
Where is the study run from?
1. Samnium Medical Cooperative (Italy)
2. Department of Pharmacy, University of Naples “Federico II” (Italy)
When is the study starting and how long is it expected to run for?
April 2016 to June 2017
Who is funding the study?
1. Samnium Medical Cooperative (Italy)
2. Department of Pharmacy, University of Naples “Federico II” (Italy)
Who is the main contact?
Professor Gian Carlo Tenore
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gian Carlo Tenore
ORCID ID
http://orcid.org/0000-0002-0251-9936
Contact details
Via Domenico Montesano
49
Naples
80131
Italy
+39081678610
giancarlo.tenore@unina.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
19.04.2016 57994
Study information
Scientific title
Effects of CHIA SEED based nutraceutical products on ACNE lesions plaques in a randomised trial
Acronym
CHIASEEDACNE
Study hypothesis
The aim of the study is to evaluate the effects of chia seed based nutraceutical products on acne lesions in human subjects.
Ethics approval
Azienda Ospedaliera Gaetano Rummo Via dell’Angelo,19/04/2016, ref: 57994
Study design
Open interventional parallel randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Acne lesions
Intervention
Participants are asked to fill out a food frequency questionnaire at the beginning of the study. Participants in all groups eat a placebo daily for one month. Participants are then randomly allocated into one of five groups.
Group 1: Participants are instructed to consume five grams of chia seeds per day for two months.
Group 2: Participants are instructed to consume five grams micronized chia seeds per day for two months.
Group 3: Participants are instructed to consume two grams of monocomponent chia seed based nutraceutical (similar to a food supplement) per day for two months.
Group 4: Participants are instructed to consume two grams of multicomponent chia seed based nutraceutical (similar to a food supplement) per day for two months.
Group 5: Participants are instructed to consume 60 milligrams of vitamin E per day for two months.
Participants are followed up with blood tests and food frequency questionnaires after 4, 6, 8, 12 and 16 weeks (in which they are asked to fast for 12 hours before the test) to see if eating chia seeds impacts their acne severity.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Severity of acne lesions are measured using the Global Acne Grading System (GAGS) score at baseline and 16 weeks.
Secondary outcome measures
1. Clinical history is measured both by interviews and previous clinical data at baseline
2. Itchiness is measured using Visual Analogue Scale (VAS) at baseline, 4, 8, 12, and 16 weeks
3. Nutrient intake and dietary habits are measured using a seven day food record validated nutritional questionnaire at baseline, 4, 8, 12, and 16 weeks
4. Blood pressure is measured using a blood pressure cuff at baseline, 4, 8, 12, and 16 weeks
5. 24 hour ambulatory blood pressure is measured using blood pressure cuff baseline, 4, 8, 12, and 16 weeks
6. Blood analysis (AST, ALT, γ-GTP, ALP, LDH, Albumin, Total bilirubin, Creatinine) is measured using a blood test (analysis by a spectrophotometer) at baseline, 4, 8, 12, and 16 weeks
Overall trial start date
01/04/2016
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women between 18-65 years of age
2. Caucasian
3. Chronic acne lesions of any severity (treated and untreated)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Smoking
2. Obesity (BMI >30 kg/m2)
3. Diabetes
4. Hepatic disease
5. Renal disease
6. Heart disease
7. Family history of chronic diseases
8. Heavy physical exercise (>10 h/week)
9. Pregnant women, women suspected of being pregnant, women who hoped to become pregnant, breastfeeding
10. Birch pollen allergy
11. Use of vitamin/mineral supplements 2 weeks prior to entry into the study
12. Donation of blood less than 3 months before the study
Recruitment start date
23/02/2017
Recruitment end date
28/02/2017
Locations
Countries of recruitment
Italy
Trial participating centre
Samnium Medical Cooperative
Viale C. Colombo, 18
Benevento
82037
Italy
Trial participating centre
Department of Pharmacy, University of Naples “Federico II” (lead centre)
via Domenico Montesano, 49
Naples
80131
Italy
Sponsor information
Organisation
Samnium Medical Cooperative
Sponsor details
Viale C.Colombo
18
Benevento
82037
Italy
0824.940424
giancarlo.tenore@unina.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Samnium Medical Cooperative
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof Gian Carlo Tenore giancarlo.tenore@unina.it
Intention to publish date
30/06/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list