Chronic Sucrose Intake, Markers of Health and Biomarker Identification

Metabolic Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04486105
• Other study ID #: 15738
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: July 2020
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age 19-64, healthy diagnosis

Exclusion Criteria:

• gastrointestinal issues, doesn't consume sugar

Related Conditions & MeSH terms

• Dietary Exposure
• Metabolic Disturbance

Intervention

Dietary Supplement:
• sucrose
pure sucrose in water in addition to habitual diet

Locations

Country	Name	City	State
United Kingdom	Northumberland Building	Newcastle Upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Measurement of systolic and diastolic blood pressure	change in blood pressure following one week intervention
Primary	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
Primary	Body composition	measurement of body mass index	change in body mass index following one week intervention
Primary	Body composition	measurement of percentage body fat	change in percentage body fat following one week intervention
Secondary	food diary analysis	measurement of energy, macro and micronutrient intakes from 3-day food diaries	change in dietary intake following the week intervention