NCT01866215

Brief Summary

A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced dyslipidemia.This study will evaluate

  1. 1.how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed before fructose ingestion 1b) when exercise is performed after fructose ingestion Metabolic effects of exercise will be assessed in healthy male subjects by measuring fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled fructose meals
  2. 2.how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion after exercise Healthy male subjects will be fed various fructose, glucose, lipid and whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The effects of meals' composition will be assessed after 24 hours by measuring intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

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

May 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

May 27, 2013

Last Update Submit

June 3, 2014

Conditions

Keywords

gluconeogenesisde novo lipogenesisintramyocellular lipidsmuscle glycogenfructose

Outcome Measures

Primary Outcomes (3)

  • Plasma triglyceride

    measurement of total and VLDL-TG concentrations in study 1

    measurements in fasting conditions and every hour from 7:00 am to 4:00 pm (up to 9 hours)

  • intramyocellular lipids

    Measurement by 1H-MRS in muscle vastus lateralis in study 2

    after glycogen/intramyocellular lipid depleting exercise and after 24 hour controlled feeding post exercise

  • Fructose conversion into lipids

    Estimated from 13C palmitate-VLDL concentration

    measured from 7:00 am to 4:00 pm in study 1 (up to 9 hours)

Secondary Outcomes (4)

  • Fructose conversion into glucose

    measured between 7:00 am and 4:oo pm (up to 9 hours)

  • intramyocellular glycogen concentrations

    after glycogen/intramyocellular lipid depleting exercise and after 24 hour controlled feeding post exercise

  • fructose oxidation

    measured from 7:00 am to 4:00 pm in study 1 (up to 9 hours)

  • exogenous lipid oxidation

    measured from 7:00 am to 4:00 pm in study 2 (up to 9 hours)

Study Arms (5)

Study1a

EXPERIMENTAL

exercice performed 90 min before 13C fructose meal ingestion

Other: exercise

study 1b

EXPERIMENTAL

exercise performed 90 min after 13C fructose meal ingestion

Other: exercise

study 1c

NO INTERVENTION

no exercise

study 2a

EXPERIMENTAL

meals containing fructose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise

Dietary Supplement: fructose

study 2b

ACTIVE COMPARATOR

meals containing glucose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise

Dietary Supplement: glucose

Interventions

cycling at 100W during 60 min

Study1astudy 1b
fructoseDIETARY_SUPPLEMENT

isocaloric nutrition with fructose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise

study 2a
glucoseDIETARY_SUPPLEMENT

isocaloric nutrition with glucose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise

study 2b

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males
  • years old
  • kg/m2\>BMI\>25kg/m2
  • moderate to high usual physical activity
  • non-smokers

You may not qualify if:

  • family history of diabetes mellitus
  • ECG anomaly
  • any medication
  • participation to blood spending or other clinical study in the 3 months before the beginning of this study
  • consumption of drugs
  • consumption of more than 50g alcool/week
  • family history of food intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

Related Publications (2)

  • Rosset R, Lecoultre V, Egli L, Cros J, Dokumaci AS, Zwygart K, Boesch C, Kreis R, Schneiter P, Tappy L. Postexercise repletion of muscle energy stores with fructose or glucose in mixed meals. Am J Clin Nutr. 2017 Mar;105(3):609-617. doi: 10.3945/ajcn.116.138214. Epub 2017 Jan 18.

  • Egli L, Lecoultre V, Cros J, Rosset R, Marques AS, Schneiter P, Hodson L, Gabert L, Laville M, Tappy L. Exercise performed immediately after fructose ingestion enhances fructose oxidation and suppresses fructose storage. Am J Clin Nutr. 2016 Feb;103(2):348-55. doi: 10.3945/ajcn.115.116988. Epub 2015 Dec 23.

MeSH Terms

Interventions

ExerciseFructoseGlucose

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Luc Tappy, MD

    University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physiology

Study Record Dates

First Submitted

May 27, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations