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Trial registered on ANZCTR


Registration number
ACTRN12614000104651
Ethics application status
Approved
Date submitted
16/10/2013
Date registered
28/01/2014
Date last updated
28/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A parallel, double-blind, randomised controlled trial to evaluate the effect of daily consumption of symbiotic yoghurt on lipid profile in mildly to moderately hypercholesterolemic men and women.
Scientific title
A parallel, double-blind, randomised controlled trial to evaluate the effect of daily consumption of symbiotic yoghurt on lipid profile in mildly to moderately hypercholesterolemic men and women.
Secondary ID [1] 282755 0
nil
Universal Trial Number (UTN)
U1111-1149-1266
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 289490 0
Hypertension 289491 0
Condition category
Condition code
Cardiovascular 289817 289817 0 0
Other cardiovascular diseases
Cardiovascular 289818 289818 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A parallel, double-blind, randomized controlled trial involving 96 non- smoking, overweight or obese, aged 30-65 will be recruited and randomly assigned into 3 groups to daily consume 200g of either control yoghurt containing 1.5% standard yoghurt cultures (Streptococcus thermophiles 1275 and Lactobacillus bulgaricus 1842), 2) symbiotic yoghurt containing 5% of probiotic mixture (1:1; Lactobacilus acidophilus ASCC 2404, Lactobacilus rhamnosus ASCC 1520), 2% Fructooligosaccharides (FOS) and inulin (synergy1), and 3) flavored symbiotic yogurt containing 5% of probiotic mixture (1:1; Lactobacilus acidophilus ASCC 2404, Lactobacilus rhamnosus ASCC 1520), 2% FOS and inulin (synergy1) and 20% concentrated pomegranate juice for 8 weeks. Anthropometric measurements and fasting blood samples will be collected at the beginning of the study, week 4 and 8.
All participants will be instructed to maintain their usual dietary habits and lifestyle and to avoid consuming any yoghurt other than that provided to them by the researchers throughout the 8-week trial. The subjects will be also instructed to keep yoghurt under refrigeration and to avoid any changes in medication if possible. The allocation of intervention or control group will be concealed from the researchers and different yoghurt treatment containers will be identical looking. Therefore, neither the subjects nor the investigator will be aware of treatment assignments in this double blind study. Yoghurt samples will be distributed weekly by the researchers. Compliance with the yogurt consumption guidelines will be monitored via phone interviews once per week. In addition, subjects will be also asked to keep a checklist of daily yoghurt consumption throughout the study period.
Information on food consumption and anthropometric measurements, and fasting blood samples will be collected at the beginning and at the end of the trial. Nutrient intakes will be estimated using a 24-h dietary recall at the beginning and at the end of the study for 3 days. Three day averages of energy and macro-nutrient intakes will be analyzed by food works software. All data entry will be performed by trained dieticians. If a participant ate a food that was not in the database, a food with very similar nutrient composition will be chosen. Nutrient information will be also obtained through food labels or recipes from participants.

ANTHEROPOMETRIC MEASUREMENTS
Anthropometric measurement of participants will include height, weight, waist and hip circumference, blood pressure and heart rate, and will be performed by the student researcher with the assistance of selected, trained student practitioners. Weight will be measured with digital scales and height measured with a stadiometer. Waist circumference will be measured twice with the participant standing with their arms crossed across their thorax with a tape measure placed around the body at the narrowest point between the lower costal (10th rib) border and the iliac crest. Hip circumference will also be measured twice, with the participant standing in a relaxed position with arms folded across their thorax at the level of the greatest posterior protuberance of the buttocks. Blood pressure and heart rate will be measured twice using an electronic blood pressure machine, where the inflatable cuff of the sphygmomanometer is positioned round the upper arm at the heart level. All measurements will be recorded on summary sheets contained in the participants file and stored in a secure locked filling cabinet.

BLOOD COLLECTION
The subjects will be directed to the nutrition clinic at the beginning of the study, week 4 and at the end of week 8 for blood tests. The blood sample will be drawn from the antecubital vein in the arm, after an overnight 8-10 h fast, at the beginning of the trial, week 4 and week 8 of intervention. The blood should be taken between 7 and 10 am on the collection day by a trained phlebotomist. The serum samples will be labelled with the participants’ code for confidentiality and stored one ice until they are centrifuged and stored at -20°c until analysed.

BIOCHEMICAL ANALYSIS
Blood samples will be analysed at the Health Scope Pathology Centre (St. Alban/ Werribee, Melbourne). Serum concentrations of Total cholesterol (TC), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C) will be measured using the standard enzymatic methods with commercially available kits.
Intervention code [1] 287421 0
Treatment: Other
Comparator / control treatment
hypercholesteromic people who receive standard yogurt samples
Control group
Active

Outcomes
Primary outcome [1] 290709 0
A 5-10 % decrease in total cholesterol and LDL cholesterol after daily consumption of symbiotic yoghurt, a yoghurt containing Lactobacilus acidophilus ASCC 2404 and Lactobacilus rhamnosus ASCC 1520 as probiotics, in combination with a mixture of fructooligosaccharide (FOS) and inulin as prebiotics in mildly to moderately hypercholesterolemic men and women compared to control group.
Blood samples will be analysed at the Health Scope Pathology Centre (St. Alban/ Werribee, Melbourne). Serum concentrations of Total cholesterol (TC), triglyceride (TG), and high-density lipoprotein cholesterol (HDL-C) will be measured using the standard enzymatic methods with commercially available kits.
Timepoint [1] 290709 0
over 8 weeks
Secondary outcome [1] 305081 0
Daily consumption of 200g symbiotic yoghurt fermented by Lactobacilus acidophilus ASCC 2404 and Lactobacilus rhamnosus ASCC 1520 as probiotics, in combination with a mixture of fructooligosaccharide (FOS) and inulin as prebiotics could decrease SBP and DBP by 4.1-6.7 mm Hg and 1.8- 5.0mm Hg, respectively.
Blood pressure will be measured in the morning 1 h after wake up, in the St Alban clinic. Physical activity and eating are prohibited before the measurement. Measurements will be done using an automated sphygmomanometer (Omron M4, Omron Matsusaka Ltd., Matsusaka, Japan), at the beginning of study, in the middle of the study trial (week 4) and at the end of the study period (week 8). Two recordings will be performed each time. If the readings in systolic pressure were not consistent and differed more than 5 mmHg, further recordings will be done. The subjects are given detailed instructions on performing the measurements. The readings will be recorded in the study diaries.
Timepoint [1] 305081 0
8 weeks

Eligibility
Key inclusion criteria
Mild to moderate hypercholesterolemic men and women (total cholesterol level less than 6.2 mmol/L and triglyceride level less than 2.3 mmol/L), with either overweight or obesity defined by waist circumference >80 cm or Body Mass Index 25-35 kg/m2. Participants will be free of serious medical conditions such as diabetes, heart disease and malignancies, and will be non allergic to dairy or lactose, non-smoking, non-pregnant and non-lactating.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with an allergy to lactose.
Pregnancy or lactation.
Smoking.
Liver, kidney or heart disease.
Type 1 diabetes and type 2 diabetes with insulin medication.
The use of any medication for weight loss.
Unable to participate for 8-week period, including preliminary information visit.
Excessive exercisers, participating in regular physical activity in excess of moderate intensity and duration as defined by NHMRC (2005) Nutrient Reference Values, where Physical Activity Levels (PAL) are greater than or equal to 2.0. That is, participants with a lifestyle primarily involving highly active leisure, significant amounts of sport or strenuous leisure activity (30-60 mins, 4-5 times/week), or heavy occupational work (e.g. high performance athletes, farmers, construction workers, miners, forest workers).
Participants with obesity caused by genetic factors or medication.
Neurological, endocrinological or other major systemic disease, including malignancy.
Acute illness or current evidence of acute or chronic inflammatory or infective disease; treatment for anemia within the past 3 months; cirrhosis or chronic hepatitis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be informed of the study via posters and pamphlets displayed at the Victoria University Nutritional Therapy clinic, the general public, community and centers, health and fitness centers, medical practices and local council offices. A global email using the same text as the flyer will also be sent to all VU staff. The flyer will be posted on campus notice boards and also posted on the VU student electronic noticeboards.
Interested participants will be able to request further information by either contacting Fatemeh Miremadi by phone or email for queries and to request information to participants form. Once prospective participants have had the opportunity to consider the information, they can contact Fatemeh Miremadi to advise of their decision.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this study is a parallel, double-blind, randomized controlled design, we first aim to achieve similar average and standard variation in the different treatment groups for the key baseline parameters ie., gender, age, body weight, plasma cholesterol and TG levels. Once similar groups have been achieved, the treatment will be randomly assigned to each group using for example toss of a coin or dice.



Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
This study is a parallel, double-blind, randomised controlled clinical trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In absence of previous studies directly relevant to the current trial, this sample size is based on 2 previously reported results. Ejtehad et al. (2011) assessed the effect of probiotics on lipid profile in two groups of type 2 diabetes over the period of 6 weeks, recruiting 60 subjects in total. Similarly Sadrzadeh-Yeganeh et al. (2010) assessed the effect of probiotics on lipid profile in 3 parallel groups (total 90 participants) for 6 weeks.

Therefore a sample size of 96 (30 per group+2 subjects extra per group allowing for a drop out) will be recruited for this three groups parallel study to determine the effect of symbiotic yoghurt on lipid profile and blood pressure in mildly to moderately hypercholesterolemic people. This is assuming an expected change of 0.25mmol/l between intervention and control groups and by considering a = 0.05 and a power of 80%, the sample size was estimated to as 30 per group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/10/2013
Actual
7/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1594 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 7471 0
3021 - St Albans
Recruitment postcode(s) [2] 7469 0
3030 - Werribee
Recruitment postcode(s) [3] 7470 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 288127 0
University
Name [1] 288127 0
Victoria University
Country [1] 288127 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Hoppers Lane,
Werribee,VIC,3030
Country
Australia
Secondary sponsor category [1] 286845 0
None
Name [1] 286845 0
Address [1] 286845 0
Country [1] 286845 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290043 0
VU Human Research Ethics Commitee
Ethics committee address [1] 290043 0
Office For Research
Footscray Park Campus, Victoria University
Ballarat Rd Footscray VIC 3011
Ethics committee country [1] 290043 0
Australia
Date submitted for ethics approval [1] 290043 0
28/02/2013
Approval date [1] 290043 0
29/08/2013
Ethics approval number [1] 290043 0
HRE13-039

Summary
Brief summary
The combination of probiotics and prebiotics is known as ‘symbiotic’. This study aims to investigate whether daily consumption of symbiotic yoghurt can improve cholesterol levels and reduce blood pressure in hypercholesterolemic individuals over 8 weeks. A parallel, double-blind, randomised controlled trial involving 96 non- smoking, overweight or obese, aged 30-65 will be recruited and randomly assigned to 3 groups to consume 300g/day of either control, symbiotic or symbiotic yoghurt containing fresh pomegranate juice. Anthropometric measurements and fasting blood samples will be collected at the beginning of the study, week 4 and 8.
Significance: Studies show that hypercholesteremia and hypertension are leading cause of morbidity and mortality in developed countries. Symbiotic food consumption may result in cholesterol and blood pressure reduction, thus reducing the chronic disease incidence. Previously the symbiotic effects have been investigated individually but not synergistically, and little is known about the mechanisms by which probiotics modulate hypocholesterolemic and anti-hypertensive effects. This is the first study examining the synergistic effect of this new symbiotic mixture in hypercholesteremic individuals. The findings will contribute in understanding the mechanisms of action of this symbiotic combination in improving health outcomes as well as new product development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41106 0
Prof Lily Stojanovskaa
Address 41106 0
College of Health and Biomedicine,
Victoria University,
PO Box 14428, Melbourne, Victoria 8001
Country 41106 0
Australia
Phone 41106 0
+ 613 9919 2737
Fax 41106 0
+613 9919 2465
Email 41106 0
Lily.Stojanovska@vu.edu.au
Contact person for public queries
Name 41107 0
Fatemeh Miremadi
Address 41107 0
College of Health and Biomedicine,
Victoria University,
PO Box 14428, Melbourne, Victoria 8001
Country 41107 0
Australia
Phone 41107 0
+613 9919 8109
Fax 41107 0
Email 41107 0
fatemeh.miremadi@live.vu.edu.au
Contact person for scientific queries
Name 41108 0
Michael Mathai
Address 41108 0
College of Health and Biomedicine,
Victoria University,
PO Box 14428, Melbourne, Victoria 8001
Country 41108 0
Australia
Phone 41108 0
+613 9919 2211
Fax 41108 0
Email 41108 0
Michael.Mathai@vu.edu.au

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