Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/02/2017
Date assigned
21/02/2017
Last edited
21/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes