ISRCTN ISRCTN26733572
DOI https://doi.org/10.1186/ISRCTN26733572
Secondary identifying numbers 19.04.2016 57994
Submission date
21/02/2017
Registration date
14/03/2017
Last edited
14/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Gian Carlo Tenore
Scientific

Via Domenico Montesano, 49
Naples
80131
Italy

ORCiD logoORCID ID 0000-0002-0251-9936
Phone +39081678610
Email giancarlo.tenore@unina.it

Study information

Study designOpen interventional parallel randomised controlled trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffects of CHIA SEED based nutraceutical products on ACNE lesions plaques in a randomised trial
Study acronymCHIASEEDACNE
Study objectivesThe aim of the study is to evaluate the effects of chia seed based nutraceutical products on acne lesions in human subjects.
Ethics approval(s)Azienda Ospedaliera Gaetano Rummo Via dell’Angelo,19/04/2016, ref: 57994
Health condition(s) or problem(s) studiedAcne lesions
InterventionParticipants 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 typeSupplement
Primary outcome measureSeverity of acne lesions are measured using the Global Acne Grading System (GAGS) score at baseline and 16 weeks.
Secondary outcome measures1. 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 study start date01/04/2016
Completion date30/06/2017

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants150
Key inclusion criteria1. Men and women between 18-65 years of age
2. Caucasian
3. Chronic acne lesions of any severity (treated and untreated)
Key exclusion criteria1. 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
Date of first enrolment23/02/2017
Date of final enrolment28/02/2017

Locations

Countries of recruitment

  • Italy

Study participating centres

Samnium Medical Cooperative
Viale C. Colombo, 18
Benevento
82037
Italy
Department of Pharmacy, University of Naples “Federico II” (lead centre)
via Domenico Montesano, 49
Naples
80131
Italy

Sponsor information

Samnium Medical Cooperative
Hospital/treatment centre

Viale C.Colombo, 18
Benevento
82037
Italy

Phone 0824.940424
Email giancarlo.tenore@unina.it
ROR logo "ROR" https://ror.org/02ww5xj89

Funders

Funder type

Not defined

Samnium Medical Cooperative

No information available

Results and Publications

Intention to publish date30/06/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe 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