Plain English Summary
Background and study aims
Eating food that contains a lot of fat can lead to hyperlipidemia, which means there are high levels of lipids (fats) in the blood. High cholesterol can cause blood clots, heart attacks and strokes. Foods that can help lower cholesterol have become popular, especially foods that are high in omega-3 and omega-6 fatty acids. These nutrients are usually found in plant oils and fish. Since Western diets are usually low in fish, it is important to look at alternative sources of omega 3 and 6. Chia seeds (small brown/black seeds found in Mexico and Guatemala) contain high levels of omega-3 and omega-6, almost similar to fish. Some research has found that they have able to lower plasma lipid levels (fat in the blood). The aim of this study is to evaluate the effects of chia seeds based food supplements on lipid plasma levels.
Who can participate?
Men and women who are slightly hyperlipidemic (higher level of fat in the blood) between 18-83 years old
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 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 4, 8, 12 and 16. Participants are followed up to see how the chia seeds affect their blood lipid levels.
What are the possible benefits and risks of participating?
Participants may benefit from a positive nutritional impact of eating chia seeds. There are no notable risks involved with participating
Where is the study run from?
Samnium Medical Cooperative (Italy)
When is the study starting and how long is it expected to run for?
February 2016 to June 2017
Who is funding the study?
1. Samnium Medical Cooperative (Italy)
2. Depatment of Pharmacy, University of Naples “Federico II” (Italy)
Who is the main contact?
Prof. 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
+39 08 167 8610
giancarlo.tenore@unina.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
22.02.2016 26875
Study information
Scientific title
Effects of CHIA SEED based nutraceutical products on LIPID metabolism in healthy subjects
Acronym
CHIA SEED LIPID
Study hypothesis
The aim of this study is to evaluate the effects of chia seed based nutraceutical products on lipid plasma levels in the subjects.
Ethics approval
Azienda Ospedaliera Gaetano Rummo Hospital, 22/02/2016, ref: 26875
Study design
Interventional randomised parallel 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
Metabolic Syndrome (MeTS)
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 lipid plasma levels.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
1. Plasma TC is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks
2. HDL-C is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks
3. LDL-C is measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks
4. Triglyceride levels are measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks
Secondary outcome measures
1. Clinical history is measured by interviews and previous clinical data at baseline
2. Anthropometric measures are measured by taking height and weight 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 at baseline, 4, 8, 12 and 16 weeks
6. Blood levels (AST, ALT, γ-GTP, ALP, LDH, Albumin, Total bilirubin, Creatinine) are measured using a blood test (analysis by spectrophotometer) at baseline, 4, 8, 12 and 16 weeks
Overall trial start date
01/02/2016
Overall trial end date
30/06/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18-83 years old
2. Caucasian
3. Have the following range values of serum cholesterol parameters at baseline:
3.1. TC, 200-260 mg/dL
3.2. HDL-C, 31-45 mg/dL
3.3. LDL-C, 190-205 mg/dL
3.4. TG, 170-280 mg/dL
4. Body mass index (BMI) between 18 and 30 kg/m2
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. Drug therapy or supplement intake for hypercholesterolemia
9. Drug therapy or supplement intake containing apple polyphenols
10. Heavy physical exercise (more than10 hours per week)
11. Pregnant women, women suspected of being pregnant, women who hoped to become pregnant, breastfeeding
12. Birch pollen allergy
13. Use of vitamin/mineral supplements 2 weeks prior to entry into the study
14. Donation of blood less than 3 months before the study
Recruitment start date
16/02/2017
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”
Via Domenico Montesano 49
Naples
80131
Italy
Sponsor information
Organisation
Samnium Medical Cooperative
Sponsor details
Viale C. Colombo 18
Benevento
82037
Italy
+39 824 940424
giancarlo.tenore@unina.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
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: Gian Carlo Tenore giancarlo.tenore@unina.it
Intention to publish date
30/06/2018
Participant level data
Available on request
Results - basic reporting
Publication summary