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Trial registered on ANZCTR


Registration number
ACTRN12617000969369
Ethics application status
Approved
Date submitted
20/06/2017
Date registered
5/07/2017
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Multivitamin and Mineral Supplement Bioavailability and Metabolic Effects in Ageing
Scientific title
Acute Multivitamin and Mineral Supplement Bioavailability and Metabolic Effects in Healthy, Young and Elderly Adults
Secondary ID [1] 292045 0
None
Universal Trial Number (UTN)
U1111-1196-7964
Trial acronym
VIOME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Digestion and metabolism 303444 0
Ageing 303743 0
Condition category
Condition code
Diet and Nutrition 302852 302852 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One tablet of multivitamin and mineral supplement to be consumed with a standard breakfast meal on one morning. Subjects will be fasted overnight prior to the intervention. The tablet will be consumed in full in the presence of the researchers to confirm compliance, to be ingested within 20 minutes. No additionally food or drink will be consumed during the 4 hour intervention. The multivitamin and mineral tablet to be consumed is Centrum Advance.

Centrum Advance Ingredients
Vitamin A (As Retinyl Acetate) 300mcg (Retinal Equivalents)
Lutein 500mcg
Lycopene 600mcg
Betacarotene 1.8mg
Vitamin B1 2.18mg
Vitamin B2 3.2mg
Nicotinamide 15mg
Vitamin B6 6mg
Vitamin B12 22mcg
Vitamin C 90mg
Vitamin D3 15mcg
Vitamin E 50mg
Vitamin K1 25mg
Biotin 45mcg
Folic Acid 400mcg
Calcium Pantothenate 10.8mg
Calcium (As Calcium Carbonate 135.3mg, Calcium Hydrogen Phosphate 64.7mg) 200mg
Phosphorus (As Calcium Hydrogen Phosphate) 50mg
Potassium (As Sulfate) 80mg
Chromium (As Chloride) 35mcg
Copper (As Sulfate) 0.5mg
Iodine (As Potassium Iodide) 150mcg
Iron (As Ferrous Fumarate) 5mg
Magnesium (As Oxide) 50mg
Manganese (As Sulfate) 3.5mg
Selenium (As Sodium Selenate) 55mcg
Zinc (As Oxide) 7.5mg
Intervention code [1] 298171 0
Lifestyle
Intervention code [2] 298412 0
Treatment: Other
Comparator / control treatment
Young adults 19-30 years
Control group
Active

Outcomes
Primary outcome [1] 302247 0
Difference in plasma vitamin B12 concentrations after consumption between old and young using HPLC
Timepoint [1] 302247 0
Baseline and hourly for 4 hours at intervention visit
Secondary outcome [1] 335276 0
Differences in plasma vitamin status after consumption between old and young using LC-MS, enzymatic colorimetric assay and LC-MS. Changes in individual vitamins and vitamers will be measured, and will include vitamins B1, B2, B3, B5, B6, B7, folic acid and their derivatives,
Timepoint [1] 335276 0
Baseline and hourly for 4 hours at intervention visit
Secondary outcome [2] 335278 0
Differences in plasma mineral concentrations after consumption between old and young using enzymatic colorimetric assays and ICP-MS. These will include targeted measurement of calcium, iron, magnesium, phosphorus, chloride, potassium, and non-targeted analyses of elements and minerals present in plasma.
Timepoint [2] 335278 0
Baseline and hourly for 4 hours at intervention visit
Secondary outcome [3] 335280 0
Differences in plasma metabolites after consumption between old and young using enzymatic colorimetric assays and non-targeted LC-MS, GC-MS and NMR. Measurements of total cholesterol, HDL-cholesterol and LDL-cholesterol will be included, as well as non-targeted analyses of metabolites..
Timepoint [3] 335280 0
Baseline and hourly for 4 hours at intervention visit
Secondary outcome [4] 335436 0
Differences in urinary vitamin status after consumption between old and young using LC-MS, enzymatic colorimetric assay and LC-MS. Changes in individual vitamins and vitamers will be measured, and will include vitamins B1, B2, B3, B5, B6, B7, folic acid and their derivatives,
Timepoint [4] 335436 0
Measured in baseline urine samples, and a continuously collected urine sample over the 4 hours post-ingestion
Secondary outcome [5] 335437 0
Differences in urinary minerals concentrations after consumption between old and young using enzymatic colorimetric assays and ICP-MS. These will include targeted measurement of calcium, iron, magnesium, phosphorus, chloride, potassium, and non-targeted analyses of elements and minerals present in urine.
Timepoint [5] 335437 0
Measured in baseline urine samples, and a continuously collected urine sample over the 4 hours post-ingestion
Secondary outcome [6] 335438 0
Differences in urinary metabolites after consumption between old and young using enzymatic colorimetric assays, LC-MS, GC-MS, ICP-MS and NMR. Targeted measurements of creatinine, urea, and uric acid will be included, as well an non-targeted metabolites..
Timepoint [6] 335438 0
Measured in baseline urine samples, and a continuously collected urine sample over the 4 hours post-ingestion
Secondary outcome [7] 336570 0
Differences in plasma glucose level after consumption between old and young using enzymatic colorimetric assay
Timepoint [7] 336570 0
Baseline and hourly for 4 hours at intervention visit
Secondary outcome [8] 336571 0
Differences in plasma insulin concentration after consumption between old and young using radio-immunoassay assay
Timepoint [8] 336571 0
Baseline and hourly for 4 hours at intervention visit
Secondary outcome [9] 336572 0
Differences in plasma triglyceride level after consumption between old and young using enzymatic colorimetric assay
Timepoint [9] 336572 0
Baseline and hourly for 4 hours at intervention visit

Eligibility
Key inclusion criteria
Young adults – males and females aged 19-30 years
Elderly adults – males and females aged 65-76 years
Healthy BMI (18-30 kg/m2)
Self-reported not consuming dietary supplements within 3 weeks
No history of gastrointestinal disease or metabolic disease
Minimum age
19 Years
Maximum age
76 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Are currently consuming multivitamin and mineral supplements
Are diagnosed with gastrointestinal disease (i.e. celiac, Crohn’s, colitis, etc.) or pre-existing metabolic disease
Are currently taking medications expected to interfere with normal digestive or metabolic processes including proton pump inhibitors, laxatives, etc.
Have a medical history precluding a healthy state: history of myocardial infarction, angina, stroke, cancer or pre-existing diabetes, self-reported alcohol intake exceeding a moderate intake (>28 units per week)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Bio-availability
Statistical methods / analysis
Two way repeated measures ANOVA will be used to determine differences in the primary endpoint. Subject group (Young vs Elderly) will be a between subject factor and time (pre/post treatment) will be a within subject factor. Principal components analysis and a multiway analysis of variance and regression models appropriate for the secondary endpoints will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8918 0
New Zealand
State/province [1] 8918 0
Auckland

Funding & Sponsors
Funding source category [1] 296576 0
University
Name [1] 296576 0
University of Auckland
Address [1] 296576 0
University of Auckland Research Office
Level 10, Building 620
49 Symonds Street
Suburb/Town: Auckland
Postcode:1010
Country [1] 296576 0
New Zealand
Funding source category [2] 296802 0
Commercial sector/Industry
Name [2] 296802 0
AgResearch Ltd.
Address [2] 296802 0
University of Auckland Research Office
Level 10, Building 620
49 Symonds Street
Suburb/Town: Auckland
Postcode:1010
Country [2] 296802 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland Research Office
Level 10, Building 620
49 Symonds Street
Suburb/Town: Auckland
Postcode:1010
Country
New Zealand
Secondary sponsor category [1] 295533 0
Commercial sector/Industry
Name [1] 295533 0
AgResearch Ltd.
Address [1] 295533 0
Grasslands Research Centre
Tennet Drive
Palmerston North
Postcode: 4442
Country [1] 295533 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297799 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 297799 0
University of Auckland Research Office
Level 10, Building 620
49 Symonds Street
Suburb/Town: Auckland
Postcode:1010
Ethics committee country [1] 297799 0
New Zealand
Date submitted for ethics approval [1] 297799 0
23/05/2017
Approval date [1] 297799 0
20/06/2017
Ethics approval number [1] 297799 0
019392

Summary
Brief summary
Micronutrient deficiency can occur in adults if their diet is unbalanced or inadequate. The elderly are at a higher risk for nutritional deficiencies. Factors such as changes in digestion, metabolism and absorption of food due to ageing, limited food choices due to weakened teeth and restrictions to physical movement may account for this. Dietary supplements can aid in reaching adequate levels of micronutrient in adults. Among these, the largest category is combinations of vitamins and minerals that are formulated to deliver a large percentage (typically 50-100%) of the recommended daily intake (RDI). Yet, the clear difference in bioavailability of micronutrient from supplements between young and elderly adults have not been established.
This study aims to investigate whether the bioavailability of a vitamin and mineral supplement is changed in the elderly, and to look at whether changes in bioavailability have an effect on metabolic processes. We hypothesise that the ageing will impair the bioavailability of vitamins and minerals, and that the metabolic profile will reflect these impairments..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75134 0
Prof David Cameron-Smith
Address 75134 0
The Liggins Institute
University of Auckland
Building 505
Grafton, Auckland
1023
Country 75134 0
New Zealand
Phone 75134 0
+6499231336
Fax 75134 0
+6493738763
Email 75134 0
d.cameron-smith@auckland.ac.nz
Contact person for public queries
Name 75135 0
Prof David Cameron-Smith
Address 75135 0
The Liggins Institute
University of Auckland
Building 505
Grafton, Auckland
1023
Country 75135 0
New Zealand
Phone 75135 0
+6499231336
Fax 75135 0
+6493738763
Email 75135 0
d.cameron-smith@auckland.ac.nz
Contact person for scientific queries
Name 75136 0
Prof David Cameron-Smith
Address 75136 0
The Liggins Institute
University of Auckland
Building 505
Grafton, Auckland
1023
Country 75136 0
New Zealand
Phone 75136 0
+6499231336
Fax 75136 0
+6493738763
Email 75136 0
d.cameron-smith@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary