Study of Protein Metabolism in Healthy Older Subjects

NCT ID: NCT02052232

Last Updated: 2016-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-04-30

Brief Summary

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This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Control protein powder sachet

Group Type ACTIVE_COMPARATOR

Control protein powder sachet

Intervention Type OTHER

mixed with 8 oz. water

Experimental

Experimental protein powder sachet

Group Type EXPERIMENTAL

Experimental protein powder sachet

Intervention Type OTHER

mixed with 8 oz. water

Interventions

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Experimental protein powder sachet

mixed with 8 oz. water

Intervention Type OTHER

Control protein powder sachet

mixed with 8 oz. water

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 60 and ≤ 75 years
* Body Mass Index (BMI) \> 23.0 to \< 30.0
* Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance
* Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study.

Exclusion Criteria

* Diagnosis of diabetes
* Active pursuit of weight loss
* Poorly controlled hypertension or hypotension
* Untreated hypothyroidism or hyperthyroidism
* Anemia or abnormally functioning kidneys or liver
* A significant cardiovascular event within ≤ 6 months; or stated history of congestive heart failure; or evidence of clinically active cardiovascular disease assessed during the screening EKG
* Peripheral arterial disease or other diseases that preclude proper limb blood flow
* Chronic, contagious, infectious disease
* Current infection or corticosteroid treatment within the last 3 months
* Clotting or bleeding disorders, stated history of Deep Vein Thrombosis (DVT) and/or a known hypercoagulable condition
* In condition deemed unsuitable for study based upon study physician assessment
* Surgery requiring \>2 days of hospitalization in the last 3 weeks and/or planned elective surgery requiring \>2 days of hospitalization during the course of the study
* Current active malignant disease or was treated within the last 6 months for cancer
* An amputee
* Obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
* Diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse
* Cannot refrain from taking

* High doses of fish oil, or omega-3 supplements, or high doses of vitamin D
* Medications/dietary supplements/herbals or substances that are considered anabolic, or reduce weight
* Any pulmonary anti-inflammatory medication or bronchodilators on the day of and 48 hours prior to study visits 1 and 2
* NSAIDS or acetaminophen on the day of and 48 hours prior to study visits 1 and 2
* Chronic use of nicotine
* Allergic or intolerant to any ingredient found in the study products
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Tian, PhD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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University of Nottingham

Derby, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BL19

Identifier Type: -

Identifier Source: org_study_id

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