Metabolic Effects of Honey or Fructose:Glucose Mixtures

NCT ID: NCT02747446

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

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

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Honey

added sugar: diet with 25% acacia honey

Group Type: EXPERIMENTAL

added sugar

Intervention Type: DIETARY_SUPPLEMENT

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

Fructose:glucose mixture

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

Group Type: EXPERIMENTAL

added sugar

Intervention Type: DIETARY_SUPPLEMENT

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

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

added sugar

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• health volunteer

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Agroscope Liebfeld Posieux, Liebfeld-Bern Switzerland

UNKNOWN

Sponsor Role: collaborator

Luc Tappy, MD

OTHER

Sponsor Role: lead

Responsible Party

Luc Tappy, MD

Professor of Physiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luc Tappy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Locations

CHUV-clinical research center

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

154/12

Identifier Type: -

Identifier Source: org_study_id