Daily Protein Intake Distribution and MPS (ARCIII) | NCT02315014

Studies
Daily Protein Intake Distribution and MPS (ARCIII)

NCT02315014

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Dec 11, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Overweight

Interventions

whey protein
placebo

Countries

Not provided

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

Nov 2014

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

Mar 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2014Actual

First Submitted Date

Nov 13, 2014

First Submission Date that Met QC Criteria

Dec 10, 2014

First Posted Date

Dec 11, 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

Dec 10, 2014

Last Update Posted Date

Dec 11, 2014Estimated

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

To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
whey protein	Experimental	whey protein micelles	Other: whey protein
placebo	Placebo Comparator	calorie-free placebo	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
whey protein	Other	whey protein.	whey protein
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
muscle protein synthesis	protein synthesis is evaluated in muscle biopsy tissue	up to 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
body composition is evaluated using DEXA		up to 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Overweight/obese (BMI 27-40 kg/m2)
Non-smokers
Non-diabetic
No history of hyperlipidemia
Not taking medications thought to interfere with study
Considered generally healthy

Exclusion Criteria:

Efforts to lose weight in previous 16 weeks
Hyperlipidemia
Blood pressure ≥ 140/90 mmHg
Smoking
Heart and other organ disease
Type 2 diabetes
Gastrointestinal disease
Orthopedic injury interfering with exercise
Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart Phillips, Ph.D.	McMaster University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000067816	Whey Proteins

Ancestor Terms

ID	Term
D008894	Milk Proteins
D000080224	Animal Proteins, Dietary
D004044	Dietary Proteins
D011506	Proteins

Browse Leaves

Not provided

Browse Branches

Not provided