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

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: added sugar

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: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
plasma total triglyceride profile	plasma triglyceride concentrations measured before and after ingestion of a breakfast and a lunch	7-day dietary intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucose tolerance	plasma glucose and insulin concentration and suppression of endogenous glucose production after ingestion of 75 g glucose	7-day dietary intervention

Collaborators and Investigators

• Sponsor: Luc Tappy, MD
• Collaborators: Agroscope Liebfeld Posieux, Liebfeld-Bern Switzerland

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 21, 2016

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 22, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: fructose, triglyceride, oral glucose tolerance
• Other Study ID Numbers: 154/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED