Metabolic Effects of Honey or Fructose:Glucose Mixtures

Healthy Clinical Trial

— HONEY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747446
• Other study ID #: 154/12
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 22, 2016
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2016
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• health volunteer

Exclusion Criteria:

• BMI < 19.5

• BMI > 25

• Smoker

• Any disease

• current treatment with any drug

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• added sugar
isocaloric substitution of added sugars (honey or FG) for starch

Locations

Country	Name	City	State
Switzerland	CHUV-clinical research center	Lausanne	VD

Sponsors (2)

Lead Sponsor	Collaborator
Luc Tappy, MD	Agroscope Liebfeld Posieux, Liebfeld-Bern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma total triglyceride profile	plasma triglyceride concentrations measured before and after ingestion of a breakfast and a lunch	7-day dietary intervention	No
Secondary	glucose tolerance	plasma glucose and insulin concentration and suppression of endogenous glucose production after ingestion of 75 g glucose	7-day dietary intervention	No