Chronic Sucrose Intake, Markers of Health and Biomarker Identification

Northumbria University

Status: Unknown

Conditions: Dietary Exposure; Metabolic Disturbance

Treatments: Dietary Supplement: sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT04486105

15738

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 19-64, healthy diagnosis

Exclusion criteria

• gastrointestinal issues, doesn't consume sugar

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

control

Placebo Comparator group

Description:

vehicle only for one week

Treatment:

Dietary Supplement: sucrose

40g sucrose ingestion

Experimental group

Description:

40g sucrose treatment on top of habitual diet for one week

Treatment:

Dietary Supplement: sucrose

80g sucrose ingestion

Experimental group

Description:

80g sucrose treatment on top of habitual diet for one week

Treatment:

Dietary Supplement: sucrose

120g sucrose ingestion

Experimental group

Description:

120g sucrose treatment on top of habitual diet for one week

Treatment:

Dietary Supplement: sucrose