Clinical trial NCT04486105: Chronic Sucrose Intake, Markers of Health and Biomarker Identification
Official title: Investigation of Sucrose-induced Metabolic Adaptation and Biomarkers of Chronic Sucrose Intake in Humans Using a Multi-omic Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dietary Exposure
Metabolic Disturbance
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 19-64, healthy diagnosis

Exclusion Criteria:

* gastrointestinal issues, doesn't consume sugar

Primary outcomes:
measure: Blood pressure
timeFrame: change in blood pressure following one week intervention
measure: Metabolome
timeFrame: change in the urinary metabolome following one week intervention
measure: Body composition
timeFrame: change in body mass index following one week intervention
measure: Body composition
timeFrame: change in percentage body fat following one week intervention
Secondary outcomes:
measure: food diary analysis
timeFrame: change in dietary intake following the week intervention
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northumberland Building
Study officials:
affiliation: Northumbria University
name: John Lodge, PhD
role: PRINCIPAL_INVESTIGATOR
References: