Chronic Sucrose Intake, Markers of Health and Biomarker Identification

NCT04486105 | Unknown

• 1 other identifier: 15738
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Exposure; Metabolic Disturbance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• food diary analysis

  change in dietary intake following the week intervention

Study Arms (4)

control

PLACEBO COMPARATOR

vehicle only for one week

Dietary Supplement: sucrose

40g sucrose ingestion

EXPERIMENTAL

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

Dietary Supplement: sucrose

80g sucrose ingestion

EXPERIMENTAL

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

Dietary Supplement: sucrose

120g sucrose ingestion

EXPERIMENTAL

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

Dietary Supplement: sucrose

Interventions

sucrose DIETARY_SUPPLEMENT

pure sucrose in water in addition to habitual diet

120g sucrose ingestion; 40g sucrose ingestion; 80g sucrose ingestion; control

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 19-64, healthy diagnosis

You may not qualify if:

• gastrointestinal issues, doesn't consume sugar

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumberland Building

Newcastle upon Tyne, NE1 7ST, United Kingdom

Location

MeSH Terms

Interventions

Sucrose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• John Lodge, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: RCT

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 24, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)