Chronic Sucrose Intake, Markers of Health and Biomarker Identification

Not Applicable

• Conditions: Dietary Exposure; Metabolic Disturbance
• Interventions: Dietary Supplement: sucrose

• Registration Number: NCT04486105
• Lead Sponsor: Northumbria University

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 Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-12-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 19-64, healthy diagnosis

Exclusion Criteria

• gastrointestinal issues, doesn't consume sugar

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	sucrose	vehicle only for one week
80g sucrose ingestion	sucrose	80g sucrose treatment on top of habitual diet for one week
120g sucrose ingestion	sucrose	120g sucrose treatment on top of habitual diet for one week
40g sucrose ingestion	sucrose	40g sucrose treatment on top of habitual diet for one week

Primary Outcome Measures

Name	Time	Method
Blood pressure	change in blood pressure following one week intervention	Measurement of systolic and diastolic blood pressure
Body composition	change in percentage body fat following one week intervention	measurement of percentage body fat
Metabolome	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 Outcome Measures

Name	Time	Method
food diary analysis	change in dietary intake following the week intervention	measurement of energy, macro and micronutrient intakes from 3-day food diaries

Trial Locations

Locations (1)

Northumberland Building; 🇬🇧 Newcastle Upon Tyne, United Kingdom