Chronic Sucrose Intake, Markers of Health and Biomarker Identification

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Disturbance; Dietary Exposure
• Intervention / Treatment: Dietary supplement: sucrose

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle Upon Tyne, United Kingdom, NE1 7ST
    • Northumberland Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 19-64, healthy diagnosis

Exclusion Criteria:

• gastrointestinal issues, doesn't consume sugar

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; vehicle only for one week	Dietary supplement: sucrose; pure sucrose in water in addition to habitual diet
Experimental: 40g sucrose ingestion; 40g sucrose treatment on top of habitual diet for one week	Dietary supplement: sucrose; pure sucrose in water in addition to habitual diet
Experimental: 80g sucrose ingestion; 80g sucrose treatment on top of habitual diet for one week	Dietary supplement: sucrose; pure sucrose in water in addition to habitual diet
Experimental: 120g sucrose ingestion; 120g sucrose treatment on top of habitual diet for one week	Dietary supplement: sucrose; pure sucrose in water in addition to habitual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Measurement of systolic and diastolic blood pressure	change in blood pressure following one week intervention
Metabolome	Metabolite profiling of urine samples, obtaining a profile of approximately 5000 metabolite intensities in urine	change in the urinary metabolome following one week intervention
Body composition	measurement of body mass index	change in body mass index following one week intervention
Body composition	measurement of percentage body fat	change in percentage body fat following one week intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northumbria University
• Investigators: Principal Investigator: John Lodge, PhD, Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 15738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No