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Clinical Trials/NCT04486105
NCT04486105UnknownNot Applicable

Investigation of Sucrose-induced Metabolic Adaptation and Biomarkers of Chronic Sucrose Intake in Humans Using a Multi-omic Approach

Northumbria University2 sites in 1 country60 target enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
2
Primary Endpoint
Blood pressure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 19-64, healthy diagnosis

Exclusion Criteria

  • gastrointestinal issues, doesn't consume sugar

Outcomes

Primary Outcomes

Blood pressure

Time Frame: change in blood pressure following one week intervention

Measurement of systolic and diastolic blood pressure

Body composition

Time Frame: change in percentage body fat following one week intervention

measurement of percentage body fat

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

Secondary Outcomes

  • food diary analysis(change in dietary intake following the week intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Lodge

Associate Professor

Northumbria University

Study Sites (2)

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