Chronic Sucrose Intake, Markers of Health and Biomarker Identification

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.

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

Conditions
-----------------
Dietary Exposure, Metabolic Disturbance

Intervention / Treatment
-----------------
* Dietary Supplement: sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19-64, healthy diagnosis Exclusion Criteria: gastrointestinal issues, doesn't consume sugar

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>vehicle only for one week | Dietary Supplement: sucrose<br>* pure sucrose in water in addition to habitual diet<br>|
| Experimental: 40g sucrose ingestion<br>40g sucrose treatment on top of habitual diet for one week | Dietary Supplement: sucrose<br>* pure sucrose in water in addition to habitual diet<br>|
| Experimental: 80g sucrose ingestion<br>80g sucrose treatment on top of habitual diet for one week | Dietary Supplement: sucrose<br>* pure sucrose in water in addition to habitual diet<br>|
| Experimental: 120g sucrose ingestion<br>120g sucrose treatment on top of habitual diet for one week | Dietary Supplement: sucrose<br>* pure sucrose in water in addition to habitual diet<br>|

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 |