Effects of chia seeds on acne

• Register: ISRCTN
• Last refreshed on: 3 April 2017
• Main ID: ISRCTN26733572
• Date of registration: 14/03/2017
• Prospective Registration: No
• Primary sponsor: Samnium Medical Cooperative
• Public title: Effects of chia seeds on acne
• Scientific title: Effects of CHIA SEED based nutraceutical products on ACNE lesions plaques in a randomised trial
• Date of first enrolment: 23/02/2017
• Target sample size: 150
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN26733572
• Study type: Interventional
• Study design: Open interventional parallel randomised controlled trial (Prevention)

Countries of recruitment

Italy

Contacts

• Name: Gian Carlo Tenore

Key inclusion & exclusion criteria

Inclusion criteria: 1. Men and women between 18-65 years of age
2. Caucasian
3. Chronic acne lesions of any severity (treated and untreated)
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Acne lesions
Skin and Connective Tissue Diseases
Acne lesions

Intervention(s)

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.

Primary Outcome(s)

Severity of acne lesions are measured using the Global Acne Grading System (GAGS) score at baseline and 16 weeks.

Secondary Outcome(s)

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, ?-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

Secondary ID(s)

19.04.2016 57994

Source(s) of Monetary Support

Samnium Medical Cooperative