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Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study (P+RISE)

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whey Protein
Whey Protein and Resistance Exericse
Whey Protein and RISE exercise routine
Sponsored by
Skidmore College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring whey protein intake, obesity, visceral fat, resistance exercise training, sprint interval training, endurance exercise training, yoga training, healthy eating, healthy lifestyle strategies, leptin, hunger

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy, overweight or obese, inactive

Exclusion Criteria:

  • smoker, exercise-trained, recent weight loss, heavy caffeine-consumer

Sites / Locations

  • Health & Exercise Sciences Department, Human Nutrition and Metabolism Laboratory, Skidmore College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Whey Protein Only

Whey Protein and Resistance Exericse

Whey Protein and RISE exercise routine

Arm Description

Ingestion of whey protein only (20 grams per serving) consumed 3X/day along with ad libitum diet for a total of 60 grams per day. One serving was consumed within 1 hour of waking in the morning; a second serving was consumed mid-afternoon; and a third serving was consumed within 2 hours of going to sleep at night.

Ingestion of whey protein (20 grams per serving) 3X/day: one serving within an hour of waking in morning; a second serving mid-afternoon or within 1 hour immediately following a resistance exercise bout on exercise days; and a third serving within 2 hours of going to bed at night.

Ingestion of whey protein (20 gram serving) 3X/day: one serving within an hour of waking in the morning; a second serving mid-afternoon or within 1 hour immediately following the RISE exercise bout; and a third serving within 2 hours of going to bed at night.

Outcomes

Primary Outcome Measures

change in visceral fat

Secondary Outcome Measures

Full Information

First Posted
October 5, 2013
Last Updated
October 9, 2013
Sponsor
Skidmore College
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1. Study Identification

Unique Protocol Identification Number
NCT01960335
Brief Title
Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study
Acronym
P+RISE
Official Title
Whey Protein With and Without Exercise Training Enhances Total and Regional Body Composition, Insulin, Leptin, and Blood Pressure in Overweight and Obese Adults - The P+RISE Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skidmore College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Dietary manipulation is proving to be an effective lifestyle strategy to combat the obesity epidemic. Increased dietary protein is one effective strategy. For example, increased whey protein ingestion with and without exercise training is associated with enhanced weight loss, body composition and subjective hunger in overweight and obese individuals. Our findings suggest that the effects of whey protein ingestion occur independent of a calorie-restricted diet and to a greater extent in individuals following a combined exercise program of resistance exercise, sprint intervals, stretching/yoga/pilates, and aerobic exercise training compared to standard resistance training.
Detailed Description
This study was a 16 week whey protein and exercise training intervention in middle aged overweight/obese adults. Subjects were randomized into 3 groups: Whey protein only consumed as 20 grams per serving three times per day (total 60 grams per day) (WP); Whey protein and resistance exercise training (WP-RT); and Whey protein and combined exercise training (P+RISE). All outcomes, including the primary outcome of visceral fat was measured at baseline (week 0) and post-intervention (week 17) in all study subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
whey protein intake, obesity, visceral fat, resistance exercise training, sprint interval training, endurance exercise training, yoga training, healthy eating, healthy lifestyle strategies, leptin, hunger

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whey Protein Only
Arm Type
Active Comparator
Arm Description
Ingestion of whey protein only (20 grams per serving) consumed 3X/day along with ad libitum diet for a total of 60 grams per day. One serving was consumed within 1 hour of waking in the morning; a second serving was consumed mid-afternoon; and a third serving was consumed within 2 hours of going to sleep at night.
Arm Title
Whey Protein and Resistance Exericse
Arm Type
Experimental
Arm Description
Ingestion of whey protein (20 grams per serving) 3X/day: one serving within an hour of waking in morning; a second serving mid-afternoon or within 1 hour immediately following a resistance exercise bout on exercise days; and a third serving within 2 hours of going to bed at night.
Arm Title
Whey Protein and RISE exercise routine
Arm Type
Experimental
Arm Description
Ingestion of whey protein (20 gram serving) 3X/day: one serving within an hour of waking in the morning; a second serving mid-afternoon or within 1 hour immediately following the RISE exercise bout; and a third serving within 2 hours of going to bed at night.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein
Intervention Description
Whey protein provided in 20 gram servings administered three times per day. once in the morning upon waking; a second serving in the mid-afternoon; and a third serving within 2 hours of going to sleep at night.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein and Resistance Exericse
Intervention Description
Subjects will receive 20 grams of whey protein three times per day along with 4 days per week of resistance exercise training throughout the 16 week intervention.
Intervention Type
Other
Intervention Name(s)
Whey Protein and RISE exercise routine
Intervention Description
Subjects will consume 20 grams of whey protein three times per day (total of 60 grams) and perform a combination of exercise involving functional resistance exercise (R); sprint intervals (I); stretching/pilates/yoga (S); and endurance exercise (E); RISE four days per week.
Primary Outcome Measure Information:
Title
change in visceral fat
Time Frame
baseline and 17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy, overweight or obese, inactive Exclusion Criteria: smoker, exercise-trained, recent weight loss, heavy caffeine-consumer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Arciero, Doctorate
Organizational Affiliation
Skidmore College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health & Exercise Sciences Department, Human Nutrition and Metabolism Laboratory, Skidmore College
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21677076
Citation
Baer DJ, Stote KS, Paul DR, Harris GK, Rumpler WV, Clevidence BA. Whey protein but not soy protein supplementation alters body weight and composition in free-living overweight and obese adults. J Nutr. 2011 Aug;141(8):1489-94. doi: 10.3945/jn.111.139840. Epub 2011 Jun 15.
Results Reference
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Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study

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