Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001036707
Ethics application status
Approved
Date submitted
19/07/2022
Date registered
25/07/2022
Date last updated
9/01/2023
Date data sharing statement initially provided
25/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the best way to measure what people eat? Comparing self-reported habitual and actual dietary intakes with metabolite markers of dietary intakes.
Scientific title
Comparing self-reported habitual and actual dietary intakes with metabolite markers of dietary intakes in healthy adults: a randomised crossover feeding study
Secondary ID [1] 307458 0
Nil
Universal Trial Number (UTN)
U1111-1280-1666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adequacy of dietary intake 326842 0
Condition category
Condition code
Diet and Nutrition 324055 324055 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three interventions in the proposed study, each two days long. The first day of each intervention is a standardisation day, the second is a day where all foods of known amounts are provided. For the standardisation days, participants will be instructed to eat, move, and sleep as they normally would, with no extremes in physical activity or other behaviours. This advice will be given for the first day of each of the three interventions. In the morning of each standardisation day participants will start to collect a 24-hour urine sample and complete it the following morning. On each intervention day, participants will provide a fasted blood sample, as well as collect another 24-hour urine sample over the course of the day. Following the blood sample, participants will then present to the metabolic facility to complete a 24-hour recall of food eaten the day before, and eat their breakfast of a prepared food while under observation. Participants will receive and eat all meals (breakfast, lunch, and dinner) in this manner on each intervention day. Meals are prepared and administered by a Dietitian within two-hour windows for each breakfast, lunch, and dinner. On intervention days, participants will be provided with snack foods of known weights to consume outside of the facility if they feel hunger, or wish to eat more. In the morning of the day after each intervention day, participants return any unconsumed snacks, their completed their 24-hour urine samples, provide a fasted blood sample and complete a 24-hour recall. The three interventions will be separated by at least three days washout, so that study requirements are not too onerous on participants.

Trial recruitment will be run out of the University of Otago Dunedin campus, in New Zealand. The interventions differ in the food provided each day for meals and snacks. In one intervention: meals will be of whole grains, seafood, and dairy while snacks will be of vegetables, red meat, nuts and seeds. On this day no fruit, chicken, egg, or legumes will be consumed. In a second intervention: meals will be of vegetables, red meat, nuts and seeds while snacks will be of fruit, chicken, egg, and legume. No whole grains, seafood, or dairy will be consumed. In a third intervention: meals will be of fruit, chicken, egg, and legumes while snacks will be of whole grains, seafood, and dairy. No vegetables, red meats, and nuts and seeds will be consumed. The meals provided each day will provide slightly less energy intake (kJ) than participants require each day, to ensure they are consumed in full, with access to the snack foods unrestricted per day to allow participants to eat until full or for other reasons. The purpose of these three interventions is to see how metabolite biomarkers of dietary intakes change in fasted plasma and 24 hour urine in response to foods of known values, as well as compare the metabolite measures with self-reported dietary assessment techniques: a food frequency questionnaire and three 24-hour recalls captured on intervention days.
Intervention code [1] 323912 0
Lifestyle
Intervention code [2] 324083 0
Early detection / Screening
Comparator / control treatment
Each participant will act as their own comparator/control group as this is a crossover study, while blood and 24 hour urine samples reflecting the preceding standardisation day will allow us to look at metabolite concentration change on intake of known foods in known amounts.
Control group
Active

Outcomes
Primary outcome [1] 331842 0
Metabolite markers of vegetable and fruit intake, including composite markers and those specific to just one specific food will be measured in fasting blood and 24 hour urine samples. There are hundreds of potential markers, examples of known markers are proline betaine, 4-hydroxyphenylacetic acid, and S-allylcysteine. We will also capture the metabolite mass to be able to comment in the future on markers of vegetable and fruit intakes not yet identified in the literature.
Timepoint [1] 331842 0
Fasted blood sample taken the morning after each of the three intervention days, 24 hour urine samples taken over the intervention day.
Primary outcome [2] 332065 0
Metabolite markers of protein based foods, including composite markers and those specific to just one specific food will be measured in fasting blood and 24 hour urine samples. There are hundreds of potential markers, examples of known markers are diadzein, Indole-3-lactic acid, carnitine. We will also capture the metabolite mass to be able to comment in the future on markers of protein-based foods not yet identified in the literature.
Timepoint [2] 332065 0
Fasted blood sample taken the morning after each of the three intervention days, 24 hour urine samples taken over the intervention day.
Primary outcome [3] 332066 0
Metabolite markers of cereal and pseudocereal (grain) intake, including composite markers and those specific to just one specific grain will be measured in fasting blood and 24 hour urine samples. There are hundreds of potential markers, examples of known markers are alkylresorcinols and avenacosides. We will also capture the metabolite mass to be able to comment in the future on markers of grain intakes not yet identified in the literature.
Timepoint [3] 332066 0
Fasted blood sample taken the morning after each of the three intervention days, 24 hour urine samples taken over the intervention day.
Secondary outcome [1] 411372 0
Metabolite markers of other consumed foods and nutrients (e.g. caffeine, resveratrol, and ethyl glucuronide, as well as exploratory markers yet to be identified) measured in fasting blood and 24 hour urine samples.
Timepoint [1] 411372 0
Fasted blood sample taken the morning after each of the three intervention days, 24 hour urine samples taken over the intervention day.
Secondary outcome [2] 412124 0
Self-reported dietary intake as captured by a 24-hour dietary recall.
Timepoint [2] 412124 0
24 hour diet recall taken the morning after each of the three standardisation days, and after each of the intervention days.

Eligibility
Key inclusion criteria
Adults aged 18-40 willing to adhere with the study requirements to standardise their lifestyle habits (physical activity, food choice, alcohol intake and sleep routine) over the three weeks of the data capture, eat the prepared foods on three feeding days, record or report their dietary intakes both habitually and on six days, provide six fasted plasma and 24-hour urine samples
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with food sensitivities, food allergies, or eating disorders that might interfere with their ability to adhere with the study requirements. Those with gastro-intestinal issues (e.g., IBS, IBD, etc.), renal issues and liver issues (i.e. any health issues affecting digestion, metabolism and clearance) or other characteristics that might interfere with their ability to adhere with the study requirements.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation of intervention order by computer (built into REDCap online portal).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of intervention order using a computerised sequence generation, stratified by sex (F/M).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As an exploratory study in a new research area, there are insufficient data available from previous studies to conduct a robust power calculation. We have instead based our sample size on those used in previous studies. Five previous studies considered measurement of 8- 58 participants in either crossover or parallel studies. Given the numbers and findings from these five studies, we have set our sample size at 21 participants completing all three interventions, however we will recruit 24 participants to account for potential drop out.

Demographic data collected at baseline will be used to describe the participants using mean values or percentages. Correlations between the known dietary intakes on intervention days and objective markers (metabolite concentrations in fasting plasma and 24-hour urine samples) as well as known dietary intakes and self-reported intakes reflecting the intervention days will be generated. Correlations between metabolite markers and self reported intakes on standardisation days as well as habitual intake will also be generated. Changes values of metabolite markers between the first (standardisation) and second (feeding) day of each intervention will be assessed.

The primary triad comparison will be the 24-hour recall, the true dietary intake (as reference) and the metabolite markers from urine for each of the days where foods are provided. An additional triad is the same 24-hour recall and reference but with the metabolite markers in fasted plasma samples. As a measure of habitual intake, Food Frequency Questionnaire (FFQ) values will be used to rank and quantify participants food intakes to compare with ranking and quantification of metabolite concentrations in the first of the standardisation day blood and urine samples. Statistical analyses will also be carried out by considering an order effect regarding learning or fatigue.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2022
Actual
30/08/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
19/10/2022
Date of last data collection
Anticipated
21/11/2022
Actual
19/11/2022
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 24854 0
New Zealand
State/province [1] 24854 0
Otago

Funding & Sponsors
Funding source category [1] 311729 0
Government body
Name [1] 311729 0
Health Research Council of New Zealand (Emerging First grant)
Country [1] 311729 0
New Zealand
Funding source category [2] 311731 0
Other
Name [2] 311731 0
Riddet Centre of Research Excellence
Country [2] 311731 0
New Zealand
Primary sponsor type
University
Name
Universilty of Otago
Address
362 Leith Street, Dunedin North, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 313191 0
None
Name [1] 313191 0
Address [1] 313191 0
Country [1] 313191 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311177 0
The University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 311177 0
Ethics committee country [1] 311177 0
New Zealand
Date submitted for ethics approval [1] 311177 0
03/06/2022
Approval date [1] 311177 0
08/07/2022
Ethics approval number [1] 311177 0
H22/075

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120226 0
Dr Andrew Reynolds
Address 120226 0
Department of Medicine
9th Floor Dunedin Hospital
201 Great King Street, Central Dunedin, Dunedin 9016
Country 120226 0
New Zealand
Phone 120226 0
+64 027 956 5826
Fax 120226 0
Email 120226 0
[email protected]
Contact person for public queries
Name 120227 0
Andrew Reynolds
Address 120227 0
Department of Medicine
9th Floor Dunedin Hospital
201 Great King Street, Central Dunedin, Dunedin 9016
Country 120227 0
New Zealand
Phone 120227 0
+64 027 956 5826
Fax 120227 0
Email 120227 0
[email protected]
Contact person for scientific queries
Name 120228 0
Andrew Reynolds
Address 120228 0
Department of Medicine
9th Floor Dunedin Hospital
201 Great King Street, Central Dunedin, Dunedin 9016
Country 120228 0
New Zealand
Phone 120228 0
+64 027 956 5826
Fax 120228 0
Email 120228 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Potential for de-identified information relating to objective measures of dietary intake (metabolite measures), self-reported measures of dietary intake (24 hour recall and Food Frequency Questionnaire), and the true intake values of food consumed on intervention days can be shared on reasonable request.
When will data be available (start and end dates)?
After publication of the stated trial, up to 10 years following publication of the stated trial.
Available to whom?
Researchers with a methodologically sound proposal - or case by case basis at discretion of Principal Investigator (Dr Andrew Reynolds, [email protected])
Available for what types of analyses?
Analyses of currently unidentified markers of dietary intakes.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr Andrew Reynolds, [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.