Effects of Milk Proteins on Protein Synthesis in Healthy... | NCT02168218

Studies
Effects of Milk Proteins on Protein Synthesis in Healthy Male Subjects Fed a Hypercaloric, High Sucrose Diet

NCT02168218

Sponsor

University of Lausanne

Status

Completed

Last Update Posted

May 4, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

7-day overfeeding

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

May 2018

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

Dec 2013

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jun 5, 2014

First Submission Date that Met QC Criteria

Jun 16, 2014

First Posted Date

Jun 20, 2014Estimated

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

May 1, 2018

Last Update Posted Date

May 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luc Tappy, MD, Professor of Physiology, University of LausannePrincipal Investigator

Lead Sponsor

University of LausanneOTHER

Collaborators

Name	Class
Insel Gruppe AG, University Hospital Bern	OTHER

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

This study aims at assessing the hypothesis that dietary protein content is a major factor regulating lean body mass gain and energy expenditure during overfeeding, and thus long term body weight gain

To test this hypothesis, healthy normal weight male and female subjects will before and after a 7-day hypercaloric, high-sucrose diet (+40% excess energy as sucrose) and either a low (5% total energy) or a high (20% total energy) protein intake. Each subject will be studied with both low- and high protein diets according to a randomized, crossover study. On each occasion the following measurements will be done in basal conditions (after 2-day isoenergetic, controled diet) and at the end of the 7-day overfeeding:

whole-body protein turnover, oxidation and synthesis in fasting conditions and fed conditions (13C-labelled leucine)
intrahepatic and intramuscular fat concentration (1H-Magnetic Resonance Spectroscopy)
Energy metabolism in fasted and fed conditions (indirect calorimetry)
plasma concentration of glucose, non-esterified fatty acids, total triglyceride, very-low density lipoprotein (VLDL)-triglyceride, insulin, glucagon, growth hormone (GH), insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein (IGFBP) 1,2 and 3 in fasting and fed conditions The effects of high-protein and low-protein sucrose overfeeding on whole body protein synthesis will be compared using two-way ANOVA; relationships between changes in whole body protein synthesis on one hand, and intrahepatic/intramuscular fat concentrations, total energy expenditure, and plasma concentration of metabolic variables on the other hand, will be evaluated by linear regression analysis

Detailed Description

Not provided

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high protein	Experimental	20% protein diet	Other: 7-day overfeeding
low protein	Active Comparator	7.5% protein diet	Other: 7-day overfeeding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
7-day overfeeding	Other	7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements	high protein low protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
whole body protein synthesis	Whole body protein synthesis, protein turnover, and protein oxidation will be calculated using 13C-labelled leucine infusion in both fasted and fed conditions	after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet

Secondary Outcomes

Measure	Description	Time Frame
intrahepatic and intramuscular fat concentration	Intrahepatic and intramuscular fat concentration will be measured by in-vivo 1H-Magnetic Resonance Spectroscopy	after two days of a run-in, isocaloric low sucrose diet and after 7 days of a hypercaloric, high sucrose diet
Energy expenditure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

good apparent health
low physical activity
non-smokers

Exclusion Criteria:

vegans or following any special diet
consumption of > 3 dl/day sweetened beverages
changes in body > +/- 3Kg over the past 3 months
contra-indications to magnetic resonance spectroscopy
drug or substance abuse
consumption > 10g/day alcohol
lactose intolerance

Accepts Healthy Volunteers

Yes

Sex

All

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

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

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Browse Branches

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