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

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ClinicalTrials.gov Identifier: NCT01960335
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : October 10, 2013
Sponsor:
Information provided by (Responsible Party):
Paul Arciero, Skidmore College

Tracking Information
First Submitted Date  ICMJE October 5, 2013
First Posted Date  ICMJE October 10, 2013
Last Update Posted Date October 10, 2013
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
change in visceral fat [ Time Frame: baseline and 17 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whey Protein Intake With and Without Exercise on Visceral Fat: The P+RISE Study
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Dietary Supplement: Whey Protein
    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.
  • Dietary Supplement: Whey Protein and Resistance Exericse
    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.
  • Other: Whey Protein and RISE exercise routine
    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.
Study Arms  ICMJE
  • Active Comparator: Whey Protein Only
    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.
    Intervention: Dietary Supplement: Whey Protein
  • Experimental: Whey Protein and Resistance Exericse
    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.
    Interventions:
    • Dietary Supplement: Whey Protein
    • Dietary Supplement: Whey Protein and Resistance Exericse
  • Experimental: Whey Protein and RISE exercise routine
    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.
    Interventions:
    • Dietary Supplement: Whey Protein
    • Other: Whey Protein and RISE exercise routine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2013)
79
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy, overweight or obese, inactive

Exclusion Criteria:

  • smoker, exercise-trained, recent weight loss, heavy caffeine-consumer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960335
Other Study ID Numbers  ICMJE whey-1001-192
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Paul Arciero, Skidmore College
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Skidmore College
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul J Arciero, Doctorate Skidmore College
PRS Account Skidmore College
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP