Protect - The Impact of a High Protein Diet on Preservati... | NCT01915030

Studies
Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass

NCT01915030

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Aug 2, 2013Estimated

Enrollment

61Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

High protein diet
standard protein diet

Countries

Netherlands

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

Jul 2013

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

Jun 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jul 31, 2012

First Submission Date that Met QC Criteria

Jul 30, 2013

First Posted Date

Aug 2, 2013Estimated

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

Jul 30, 2013

Last Update Posted Date

Aug 2, 2013Estimated

Name	Class
Maastricht University	OTHER
Top Institute Food and Nutrition	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

The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.

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

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High protein diet	Experimental	High protein diet during caloric restriction	Other: High protein diet
Standard protein diet	Placebo Comparator	Standard protein diet during caloric restriction	Other: standard protein diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High protein diet	Other	controlled feeding trail. Both arms are caloric restricted	High protein diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Body composition	DEXA scan	baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Physical performance	Short Physical Performance Battery (SPPB), maximum score is 12. Leg strength by 1 Repetition Maximum, both leg extension and leg press Handgrip strength Time to walk 400m	baseline and 12 weeks
Blood related parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Overweight and obese subjects (BMI 27-40 kg/m2)
Waist circumference male:≥ 102 cm, female: ≥ 88 cm
Willingness and ability to comply with the protocol

Exclusion Criteria:

Renal insufficiency
Co-morbidities
Type 1 & 2 diabetics (Fasting glucose level ≥ 7 mmol/L)
Cancer
COPD
Participation in weight loss program 3 months before the intervention
Participation of any heavy resistance-type exercise training (>1 wk) the last 2 y.
Intentional or unintentional weight loss (> 3 kg in the last 3 months)
Severe loss appetite
Diagnosed allergy to milk products
Gastric bypass
Supplements or medication use for weight loss
Participation in any other intervention trial
Women can only participate if they are postmenopausal (last period ≥ a year ago)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

70 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
Lisette de Groot, professor	Prof. Wageningen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wageningen University		Wageningen	Gelderland	6703HD	Netherlands

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

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073600	Diet, High-Protein

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

Not provided

Browse Branches

Not provided