Metabolic Effects of Honey or Fructose:Glucose Mixtures (HONEY)

April 22, 2016 updated by: Luc Tappy, MD

Effects of a Dietary Honey or Isomolar Fructose:Glucose Mixture on Glucose Tolerance and Blood Lipid Profile in Healthy Male Volunteers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eight health males volunteers will be studied three times in a randomized order

  • Honey: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, 25% acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing honey; on day 8, they will have a 75g oral glucose4 + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
  • FG: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, and 25% of a fructose:glucose mixture matching the composition of acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing fructose and glucose; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
  • Control: volunteers will be fed a weight-maintenance diet containg 5% sugars, 45% starch, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch with no added sugar; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, CH-1011
        • CHUV-clinical research center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • health volunteer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Honey
added sugar: diet with 25% acacia honey
Dietary supplement: added sugar
isocaloric substitution of added sugars (honey or FG) for starch
Experimental: Fructose:glucose mixture
added sugar: Diet with 25% energy as a fructose:glucose mixture
Dietary supplement: added sugar
isocaloric substitution of added sugars (honey or FG) for starch
No Intervention: control
no intervention: Diet with 45% starch and no honey or added sugars

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
plasma total triglyceride profile
Time Frame: 7-day dietary intervention
plasma triglyceride concentrations measured before and after ingestion of a breakfast and a lunch
7-day dietary intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
glucose tolerance
Time Frame: 7-day dietary intervention
plasma glucose and insulin concentration and suppression of endogenous glucose production after ingestion of 75 g glucose
7-day dietary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luc Tappy, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agroscope Liebfeld Posieux, Liebfeld-Bern Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 154/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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