NCT02478541

Brief Summary

High levels of fatty substances in the blood increase the risk of developing coronary heart disease and having a heart attack. The investigators know a lot about one of these fatty substances, cholesterol. However, there is another fatty substance in the blood called triglyceride. The investigators do not understand much about what regulates the rate at which the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s). The investigators are developing new techniques to measure these processes in healthy people. Ultimately a deeper understanding of the regulation of this process might lead to the development of new treatments for fat accumulation in the liver and high blood fat levels and related disorders. The present study is an investigation of how these processes relate to various bodily characteristics such as thinness and fatness and the distribution of fat in the body.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 20, 2017

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

June 15, 2015

Last Update Submit

January 19, 2017

Conditions

Hypertriglyceridaemia

Keywords

triglyceridesglucosefructosefatty acids

Outcome Measures

Primary Outcomes (1)

  • Plasma Triglycerides

    Postprandial plasma triglyceride concentrations will be measured biochemically, on a clinical analyser by taking regular blood samples from participants for a period of up to 7 hours after participants have consumed the test meal.

    7 hours

Secondary Outcomes (1)

  • Plasma glucose

    7 hours

Study Arms (2)

Sugar Study_low fructose

ACTIVE COMPARATOR

Consumption of a single test meal that contains fat and a sugary drink made with a low amount of fructose and high amount of glucose

Other: Sugar study

Sugar Study_high fructose

ACTIVE COMPARATOR

Consumption of a single test meal that contains fat and a sugary drink made with a high amount of fructose and low amount of glucose

Other: Sugar study

Interventions

Sugar studyOTHER

Subjects are given a single test meal on two study days that has a sugary drink that varies in the amount of fructose and glucose it contains. They consume the same amount of fat on both study days.

Sugar Study_high fructoseSugar Study_low fructose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • BMI \>19 \<35kg/m2
  • No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism

You may not qualify if:

  • Age \<18 or \>65 years
  • Body mass index \<19 or \>35kg/m2
  • A blood haemoglobin \<120mg/dL
  • Any metabolic condition or relevant drug therapy
  • People who do not tolerate fructose
  • Smoking
  • History of alcoholism or a greater than recommended alcohol intake
  • Pregnant or nursing mothers
  • Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months
  • History of severe claustrophobia
  • Presence of metallic implants, pacemaker
  • Haemorrhagic disorders
  • Anticoagulant treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Centre for Diabetes, Endocrinology and Metabolism

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Leanne Hodson, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 23, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

January 20, 2017

Record last verified: 2016-11

Locations

GB(1)