NCT02747446

Brief Summary

The metabolic effects of 7-day weight-maintenance diets containing 10% total energy as acacia honey or a fructose:glucose mixture will be assessed in a group of healthy male volunteers. Primary outcome is plasma total triglyceride concentrations after ingestion of standardized breakfast and lunch containing 25% energy as honey or fructose:glucose mixture; secondary outcome is glucose tolerance and suppression of endogenous glucose production after ingestion of 75 g glucose. Results obtained with 10% honey and 10% fructose: glucose mixture diets will be compared to results obtained with a weight-maintenance, isocaloric diet in which starch is substituted for honey or fructose:glucose mixture

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 healthy

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable healthy

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

January 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

April 19, 2016

Last Update Submit

April 22, 2016

Conditions

Healthy

Keywords

fructose, triglyceride, oral glucose tolerance

Outcome Measures

Primary Outcomes (1)

  • plasma total triglyceride profile

    plasma triglyceride concentrations measured before and after ingestion of a breakfast and a lunch

    7-day dietary intervention

Secondary Outcomes (1)

  • glucose tolerance

    7-day dietary intervention

Study Arms (3)

Honey

EXPERIMENTAL

added sugar: diet with 25% acacia honey

Dietary Supplement: added sugar

Fructose:glucose mixture

EXPERIMENTAL

added sugar: Diet with 25% energy as a fructose:glucose mixture

Dietary Supplement: added sugar

control

NO INTERVENTION

no intervention: Diet with 45% starch and no honey or added sugars

Interventions

added sugarDIETARY_SUPPLEMENT

isocaloric substitution of added sugars (honey or FG) for starch

Fructose:glucose mixtureHoney

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • health volunteer

You may not qualify if:

  • BMI \< 19.5
  • BMI \> 25
  • Smoker
  • Any disease
  • current treatment with any drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV-clinical research center

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

MeSH Terms

Interventions

Sugar-Sweetened Beverages

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Physiology

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 21, 2016

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

CH(1)