Dietary ExposureNCT04486105
Chronic Sucrose Intake, Markers of Health and Biomarker Identification
A study testing sucrose in people with Dietary Exposure and Metabolic Disturbance, run by Northumbria University at 1 site in United Kingdom.
Trial summary
With free sugar intake proving to be of a concern within the general public, discovery and validation of a new biomarker will allow for more consistent measurement of sucrose intake. Furthermore, using a multi-omic approach the investigators will identify metabolic perturbations to the metabolome and proteome. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure, Metabolic Disturbance
- What is being tested?
- sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19-64, healthy diagnosis
Who cannot join
- gastrointestinal issues, doesn't consume sugar
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumberland Building
Newcastle upon Tyne, NE1 7ST
About this study
Official title: Investigation of Sucrose-induced Metabolic Adaptation and Biomarkers of Chronic Sucrose Intake in Humans Using a Multi-omic Approach
With free sugar intake proving to be of a concern within the general public, discovery and validation of a new biomarker will allow for more consistent measurement of sucrose intake. Furthermore, using a multi-omic approach the investigators will identify metabolic perturbations to the metabolome and proteome.
Read the detailed description
Excessive free sugar intake is of concern within the general public, as intakes have been associated with weight gain and cardiovascular disease. Average intakes are over double that of the 5% of total energy intake that is recommended by the Science Advisory Committee on Nutrition, but intakes are calculated from observational measures that lack sensitivity and discovery and validation of a new biomarker from biological fluids may allow for more specific measurement and a better understanding of intake:disease relationships. Furthermore, understanding the biochemistry of sucrose intake will allow the identification of damage occurrence and alternative metabolic pathways, as well as novel protein damage that occur with chronic sucrose exposure.
This study aims to identify a biomarker of chronic sucrose consumption using metabolite profiling technology. The study will be composed of a randomised controlled intervention trial, in which participants will be required to consume an amount of sucrose (0-120g/d) every day for 7 days and provide biofluid samples (urine and blood) before the initiation, during and following the intervention; that will undergo metabolic analysis. Furthermore, participants will have their anthropometrics and dietary intake monitored throughout the study. The biomarker will also be validated against the dietary information and correlated with indices of health and sucrose-induced damage. The investigators will also monitor the feasibility and acceptability of chronic sucrose intake during the intervention.
- Conditions
- Dietary Exposure, Metabolic Disturbance
- Being tested
- sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucroseDietary supplement
pure sucrose in water in addition to habitual diet
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | vehicle only for one week Receives: Dietary Supplement: sucrose |
| 40g sucrose ingestion | Experimental | 40g sucrose treatment on top of habitual diet for one week Receives: Dietary Supplement: sucrose |
| 80g sucrose ingestion | Experimental | 80g sucrose treatment on top of habitual diet for one week Receives: Dietary Supplement: sucrose |
| 120g sucrose ingestion | Experimental | 120g sucrose treatment on top of habitual diet for one week Receives: Dietary Supplement: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measurement of systolic and diastolic blood pressure
Measured: change in blood pressure following one week intervention
Metabolome
Metabolite profiling of urine samples, obtaining a profile of approximately 5000 metabolite intensities in urine
Measured: change in the urinary metabolome following one week intervention
Body composition
measurement of body mass index
Measured: change in body mass index following one week intervention
Body composition
measurement of percentage body fat
Measured: change in percentage body fat following one week intervention
Secondary outcomes (1)
food diary analysis
measurement of energy, macro and micronutrient intakes from 3-day food diaries
Measured: change in dietary intake following the week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jan 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lodge, Northumbria University
- Investigators
- John Lodge, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486105
- Sponsor's protocol ID
- 15738
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Sucrose-induced Metabolic Adaptation and Biomarkers of Chronic Sucrose Intake in Humans Using a Multi-omic Approach
- ClinicalTrials.gov ID
- NCT04486105
- Acronym / sponsor ID
- 15738
- Conditions
- Dietary Exposure, Metabolic Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With free sugar intake proving to be of a concern within the general public, discovery and validation of a new biomarker will allow for more consistent measurement of sucrose intake. Furthermore, using a multi-omic approach the investigators will identify metabolic perturbations to the metabolome and proteome.
Detailed description
Excessive free sugar intake is of concern within the general public, as intakes have been associated with weight gain and cardiovascular disease. Average intakes are over double that of the 5% of total energy intake that is recommended by the Science Advisory Committee on Nutrition, but intakes are calculated from observational measures that lack sensitivity and discovery and validation of a new biomarker from biological fluids may allow for more specific measurement and a better understanding of intake:disease relationships. Furthermore, understanding the biochemistry of sucrose intake will allow the identification of damage occurrence and alternative metabolic pathways, as well as novel protein damage that occur with chronic sucrose exposure.
This study aims to identify a biomarker of chronic sucrose consumption using metabolite profiling technology. The study will be composed of a randomised controlled intervention trial, in which participants will be required to consume an amount of sucrose (0-120g/d) every day for 7 days and provide biofluid samples (urine and blood) before the initiation, during and following the intervention; that will undergo metabolic analysis. Furthermore, participants will have their anthropometrics and dietary intake monitored throughout the study. The biomarker will also be validated against the dietary information and correlated with indices of health and sucrose-induced damage. The investigators will also monitor the feasibility and acceptability of chronic sucrose intake during the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Dietary Supplement: sucrosevehicle only for one week |
| 40g sucrose ingestion | Experimental | Dietary Supplement: sucrose40g sucrose treatment on top of habitual diet for one week |
| 80g sucrose ingestion | Experimental | Dietary Supplement: sucrose80g sucrose treatment on top of habitual diet for one week |
| 120g sucrose ingestion | Experimental | Dietary Supplement: sucrose120g sucrose treatment on top of habitual diet for one week |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 19-64, healthy diagnosis
Key exclusion criteria (1 listed)
- gastrointestinal issues, doesn't consume sugar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sucrosepure sucrose in water in addition to habitual diet | Dietary supplement | 120g sucrose ingestion, 40g sucrose ingestion, 80g sucrose ingestion, control |
Primary outcome
Blood pressure
Time frame: change in blood pressure following one week intervention
Measurement of systolic and diastolic blood pressure
Metabolome
Time frame: change in the urinary metabolome following one week intervention
Metabolite profiling of urine samples, obtaining a profile of approximately 5000 metabolite intensities in urine
Body composition
Time frame: change in body mass index following one week intervention
measurement of body mass index
Body composition
Time frame: change in percentage body fat following one week intervention
measurement of percentage body fat
1 secondary outcome
food diary analysis
Time frame: change in dietary intake following the week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Lodge, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sucrose in people with Dietary Exposure and Metabolic Disturbance, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: change in blood pressure following one week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.