Chronic Sucrose Intake, Markers of Health and Biomarker Identification

NCT ID: NCT04486105

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Dietary Exposure Metabolic Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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control

vehicle only for one week

Group Type PLACEBO_COMPARATOR

sucrose

Intervention Type DIETARY_SUPPLEMENT

pure sucrose in water in addition to habitual diet

40g sucrose ingestion

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

Group Type EXPERIMENTAL

sucrose

Intervention Type DIETARY_SUPPLEMENT

pure sucrose in water in addition to habitual diet

80g sucrose ingestion

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

Group Type EXPERIMENTAL

sucrose

Intervention Type DIETARY_SUPPLEMENT

pure sucrose in water in addition to habitual diet

120g sucrose ingestion

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

Group Type EXPERIMENTAL

sucrose

Intervention Type DIETARY_SUPPLEMENT

pure sucrose in water in addition to habitual diet

Interventions

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sucrose

pure sucrose in water in addition to habitual diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 19-64, healthy diagnosis

Exclusion Criteria

* gastrointestinal issues, doesn't consume sugar
Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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John Lodge

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Lodge, PhD

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

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Northumberland Building

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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15738

Identifier Type: -

Identifier Source: org_study_id

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