Metabolic Effects of Honey or Fructose:Glucose Mixtures | NCT02747446

Studies
Metabolic Effects of Honey or Fructose:Glucose Mixtures

NCT02747446

Sponsor

Luc Tappy, MD

Status

Completed

Last Update Posted

Apr 25, 2016Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

added sugar

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Apr 19, 2016

First Posted Date

Apr 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2016

Last Update Posted Date

Apr 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luc Tappy, MD, Professor of Physiology, University of LausanneSponsor-Investigator

Lead Sponsor

Luc Tappy, MDOTHER

Collaborators

Name	Class
Agroscope Liebfeld Posieux, Liebfeld-Bern Switzerland	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
added sugar	Dietary Supplement	isocaloric substitution of added sugars (honey or FG) for starch	Fructose:glucose mixture Honey

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

health volunteer

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luc Tappy, MD	University of Lausanne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHUV-clinical research center		Lausanne	Canton of Vaud	CH-1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000080845	Sugar-Sweetened Beverages

Ancestor Terms

ID	Term
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

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Browse Branches

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