Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001316493
Ethics application status
Approved
Date submitted
14/09/2016
Date registered
20/09/2016
Date last updated
20/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a combined Vitamin D, Omega 3, Co-enzyme Q10, Zeaxanthin, Lutein and Astaxanthin supplement (Lester’s Oil) on Healthy people
Scientific title
Effects of a combined Vitamin D, Omega 3, Co-enzyme Q10, Zeaxanthin, Lutein and Astaxanthin supplement (Lester’s Oil) on Healthy people
Secondary ID [1] 290154 0
Nil known
Universal Trial Number (UTN)
U1111-1187-5726
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 300274 0
Fatty acid profiles 300285 0
Condition category
Condition code
Diet and Nutrition 300141 300141 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 300142 300142 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double blinded, randomised, placebo controlled, cross-over trial
This trial will involve 30 healthy participants who will be randomised to two treatment groups, each group consisting of 15 participants. In the first group, the 15 participants will take the nutrient supplement (Lester's Oil) or placebo for 4 weeks. Each nutrient capsule is made up mainly of six ingredients: vitamin D:25-OH (500IU), long chain PUFA-Omega-3 from fish oil [more than 500mg] as well as CoQ10 (50mg), zeaxanthin (0.82mg), lutein (3mg) and astaxanthin (500mcg). Each nutrient capsule also contains natural mixed tocopherols, vitamin E with ascorbyl palmitate (1mg) and is enclosed in a soft gel composed of gelatin, glycerine soft gel, beeswax and natural annatto. This will follow with a 4 week period of no supplementation and then another four week period of taking a similarly encapsulated ‘medium-chain tryglyceride oil’ placebo. The placebo was a Medium Chain triglyceride oil – [MCT- 8+10 Triglyceride] (MCT). Its major components were FAD - C6:0 Caproic 0.0 2.0%; FAD - C8:0 Caprylic 50.0 -80.0 %; FAD - C10:0 Capric 20.0 -50.0 %; FAD - C12:0 Lauric 0.03.0 %.
Two capsules of the nutrient supplement or placebo were taken daily, (orally), with the participants lunch or dinner meal

The second group will take the encapsulated ‘medium-chained oil’ placebo for the first four weeks, followed by a four week period of no supplementation. The nutrient supplement will then be taken for the remaining four weeks,

All participants are blinded to the treatment regime they are on.

The levels of CoQ10 were determined in serum for each trial participant at each collection point as a measure of dietary uptake and compliance in the study. Participants were also asked to return their containers of left over capsules (more capsules than needed by the study were given) and these were counted as another indicator of compliance.
Intervention code [1] 295904 0
Treatment: Other
Comparator / control treatment
The placebo used is a medium-chain tryglyceride oil’ (MCT-8+10 Triglycerides)
Two capsules of the placebo were taken daily, (orally), with the participants lunch or dinner meal
Control group
Placebo

Outcomes
Primary outcome [1] 299627 0
The measurement of vitamin D from serum samples at four time points.
The method used for analysis was isotope-dilution liquid chromatography-tandem mass spectrometry (LCMS) of serum 25(OH)D concentration
Timepoint [1] 299627 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Primary outcome [2] 299644 0
Inflammation Biomarkers at four time points
1.C-reactive protein (CRP) levels in blood plasma were measured using the CRP assay kit from Roche
2. Faecal calproctectin The calprotectin scoring was analysed using Bühleman’s Quantum Blue calprotectin quantitative lateral flow assay
Timepoint [2] 299644 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Primary outcome [3] 299645 0
Measurement of availability of Omega-3 PUFA as measured by lipid profiling ( FAME's analysis) from serum at four time points.
Timepoint [3] 299645 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Secondary outcome [1] 327710 0
Quality of Life Questionnaire using the ‘Single Numeric Rating Score’. The scale has been reported to show excellent correlation with the Crohn’s disease activity index (CDAI) (R2 = 0.59, p\0.0001), the IBD Questionnaire (IBDQ) (R2 =0.66, p\0.0001), and the Harvey Bradshaw Index (HBI) (R2 = 0.32, p\0.0001) as reported by Surti B, Spiegel B, Ippoliti A, Vasiliauskas EA, Simpson P, Shih DQ, et al. Assessing health status in inflammatory bowel disease using a novel single-item numeric rating scale. Dig Dis Sci. 2012:1-9.
Timepoint [1] 327710 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Secondary outcome [2] 327711 0
Measuring diet quality using 'The Food Variety Score' as reported by Savige G, Hsu-Hage B, Wahlqvist M. Food variety as nutritional therapy. Current therapeutics. 1997;38(3):57-67.
Timepoint [2] 327711 0
The score was completed at the end of each week of the trial for 12 weeks
Secondary outcome [3] 327725 0
Measurement of Carotenoids
Serum aliquots were evaluated by UPLC/LCMS at four time points
Timepoint [3] 327725 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Secondary outcome [4] 327726 0
Lipid peroxidation
Plasma samples were assayed for oxidised LDL by enzyme-linked immunosorbent assay (ELISA; Mercodia Version 12.0, lot 23328; Winston-Salem, NC, USA), as described by the manufacturer at four time points.
Timepoint [4] 327726 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Secondary outcome [5] 327727 0
lipids (HDL, Cholesterol, Chol/HDL-Ratio, LDL and Triglycerides.)
Plasma samples for these lipids were measured at four time points:

Plasma samples were out sourced to a Medical Laboratory for analysis
Timepoint [5] 327727 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Secondary outcome [6] 327734 0
Co-enzyme Q10 (Ubiquinone)
Serum aliquots were evaluated for Co-enzyme Q10 (Ubiquinone) by LC-MS at four time points.
Timepoint [6] 327734 0
Time Points
T1 -at the start of the intervention of Phase One
T2 - at the end of the intervention of Phase One
T3 -at the beginning of the intervention of Phase Two which was also at the end of the washout period
T4 - at the end of the intervention of Phase Two and the end of the trial
Secondary outcome [7] 327737 0
Complete Blood Count
The following measures were included : Haemoglobin, Red Cell Count, Haemocrit, Mean cell volume , Mean cell haemoglobin , Red cell distribution width, Platelet Count, Immature granulocytes, White Cell Count, Neutrophils , Basophils, Eosinophils, Monocytes and Lymphocytes and measured at two time points:

Plasma samples for these were out sourced to a Medical Laboratory for analysis
Timepoint [7] 327737 0
Time Points
T1 -at the start of the intervention of Phase One

T4 - at the end of the intervention of Phase Two and the end of the trial
Secondary outcome [8] 327741 0
Faecal and symptom Diary
Observations:
1. Frequency of bowel movements
2. Consistency (hard=4, medium=3, soft=2, runny=1).
3. Ease (hard=3, ok=2, easy=1),
4. Volume (lots=3, medium=2, small=1),
Using the Bristol Stool Chart as a guide and as has been previously described by Rush EC, Patel M, Plank LD, Ferguson LR. Kiwifruit promotes laxation in the elderly. Asia Pac J Clin Nutr. 2002;11(2):164-8.
Timepoint [8] 327741 0
Completed daily after every bowel movement through the whole trial of 12 weeks

Eligibility
Key inclusion criteria
Free from any major illnesses or chronic conditions
Not currently taking any Vitamin D, fish oil/flax seed oil supplements, or eating more than 4 servings of oily fish (salmon, mackerel) each week.
Be able to fast overnight and be able to attending the study clinic
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A history of cancer in last 5 years excluding non- melanoma skin cancers
A history of gastrointestinal disorders (Ulcerative colitis, Crohns Disease or Irritable Bowel Syndrome)
Prescribed medication changes in last 3 months prior to the trial
Have taken antibiotics in the month prior to the study commences
On blood thinning medication (e.g. Aspirin)
Pregnancy
Smoking more than 10 pack years

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
General linear mixed model
The number of participants selected for this trial was based on the Jorgensen’s et al. ‘Vitamin D3 treatment in Crohn’s disease–a randomized double-blind placebo-controlled study’ (Jorgensen SP, Agnholt J, Glerup H, Lyhne S, Villadsen GE, Hvas CL, et al. Clinical trial: vitamin D3 treatment in Crohn’s disease–a randomized double-blind placebo-controlled study. Aliment Pharmacol Ther. 2010;32(3):377-83) .This data indicates that the difference in the response of matched pairs is normally distributed with standard deviation 4. If the true difference in the mean response of matched pairs is 27 we will be able to reject the null hypothesis that this response difference is zero with probability (power) 1.000. The Type I error probability associated with this test of this null hypothesis is 0.05. Based on these prior data, the proposed numbers are appropriate to detect a true difference in the key outcome measure (vitamin D level). (R: A language and environment for statistical computing [Internet]. Vienna: R Foundation for Statistical Computing, Vienna, Austria.; 2013 [cited February 2014]. Available from: http://www.R-project.org/.)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/02/2014
Date of last participant enrolment
Anticipated
Actual
17/03/2014
Date of last data collection
Anticipated
Actual
17/06/2014
Sample size
Target
30
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 8228 0
New Zealand
State/province [1] 8228 0
Auckland

Funding & Sponsors
Funding source category [1] 294523 0
University
Name [1] 294523 0
University Of Auckland
Country [1] 294523 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Discipline of Nutrition and Dietetics,
Faculty of Medical and Health Sciences,
University of Auckland,
85 Park Rd.,
Grafton Campus, Auckland, New Zealand 1142
Country
New Zealand
Secondary sponsor category [1] 293386 0
Commercial sector/Industry
Name [1] 293386 0
About Health
Address [1] 293386 0
Khyber Pass Rd,
Newmarket, Auckland 1023
Country [1] 293386 0
New Zealand
Secondary sponsor category [2] 293400 0
Commercial sector/Industry
Name [2] 293400 0
Ministry of Business, Innovation and Employment
Address [2] 293400 0
15 Stout Street, Wellington 6011

PO Box 1473, Wellington 6140
Country [2] 293400 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295956 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 295956 0
Ministry of Health,Ethics department, Freyberg Building,
Reception-Ground Floor,
20 Aitken Street,
Wellington 6011
New Zealand
Ethics committee country [1] 295956 0
New Zealand
Date submitted for ethics approval [1] 295956 0
28/11/2013
Approval date [1] 295956 0
13/02/2014
Ethics approval number [1] 295956 0
NTY/11/11/109/AM06

Summary
Brief summary
Introduction:
Diet is a key component in the disease susceptibility of individuals. Vitamin D, omega 3 polyunsaturated fatty acids, Co-enzyme Q10 and carotenoids are associated with immune regulatory functions. Vitamin D supplementation, omega 3 fatty acids and antioxidants have been shown to be beneficial in reducing inflammation especially in people with inflammatory disorders e.g. inflammatory bowel disease.

Study Design:
Double blinded, randomised, with cross-over. The study population (n=30) was recruited from Auckland, New Zealand. The intervention , the nutrient supplement, Lester's Oil - Registered trade mark) or the control (the medium chain triglyceride-[MCT- 8+10 Triglycerides] was for four weeks, followed by a washout of four weeks followed by the control or intervention for four weeks.

Methods
Blood, urine and faecal samples were collected before and after each 4 week intervention from the participants and inflammatory markers (C-reactive protein and faecal calprotectin), vitamin D:25-OH, plasma lipid metabolic profiling (FAMES), lipid profiles, Co-enzyme Q10, carotenoids, lipid peroxidation, and full blood count measures were taken. A food variety score (FVS), Quality of Life (QoL) and stool questionnaires were also conducted. The QoL score was measured using a numeric scale from 1 – 10. The FVS was a list of foods and participants indicated which ones were eaten over each seven day time period. The stool chart measured daily frequency, ease, volume and consistency of each stool on a number scale. The outcomes of interest were measured at baseline, and the end of each phase or at the end of the trial.
Trial website
Trial related presentations / publications
Publication:
Medium Chain Triglyceride Oil, an intended placebo with unexpected adverse effects. Ferguson, LR; Laing, B; Ellett, S; Marlow, G; Jesuthasan, A; Karunasinghe, N and Eyres, L. Ann Clin Lab Res.,2016, 4 (3)105. DOI 10.21767/2386-5180.1000105
Presentations:
1. The effects of a Vitamin D, Omega 3, Co-enzyme Q10, Zeaxanthin, Lutein and Astaxanthin supplement (Lester’s Oil (Registered trade Mark) on Healthy people. Part One: Effects on Inflammatory Markers and Lipids. Laing, B; Ellett, S; Marlow, G; Jesuthasan, A; Han, DY and Ferguson, LR. ‘Queenstown Research week’. 23rd-29th August 2014
2. The Effects of a Nutrient Supplement on Fatty Acid Concentrations and an Inflammation Marker on Healthy People' Laing, B; Aggio, R; Ellett, S; Marlow, G; Jesuthasan, A; Agnew, M and Ferguson, LR. Nutrition Society of New Zealand and the Nutrition Society of Australia Joint Scientific Meeting 'Past, Present and Future: 100 Years of Nutrition' 2-4 Dec 2015, Wellington 2015
Public notes

Contacts
Principal investigator
Name 69050 0
Prof Lynnette R Ferguson
Address 69050 0
Discipline of Nutrition and Dietetics,
Faculty of Medical and Health Sciences,
University of Auckland,
85 Park Road,
Grafton Campus,
Auckland,
New Zealand 1142
Country 69050 0
New Zealand
Phone 69050 0
+64 9 9236372
Fax 69050 0
+64 9 3737502
Email 69050 0
[email protected]
Contact person for public queries
Name 69051 0
Ms Bobbi Laing
Address 69051 0
Discipline of Nutrition and Dietetics,
Faculty of Medical and Health Sciences,
University of Auckland,
85 Park Road,
Grafton Campus,
Auckland,
New Zealand 1142
Country 69051 0
New Zealand
Phone 69051 0
+64 9 923 7528
Fax 69051 0
+64 9 3737502
Email 69051 0
[email protected]
Contact person for scientific queries
Name 69052 0
Ms Bobbi Laing
Address 69052 0
Discipline of Nutrition and Dietetics,
Faculty of Medical and Health Sciences,
University of Auckland,
85 Park Road,
Grafton Campus,
Auckland,
New Zealand 1142
Country 69052 0
New Zealand
Phone 69052 0
+64 9 923 7528
Fax 69052 0
+64 9 3737502
Email 69052 0
[email protected]

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