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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

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Dietary Supplement: Whey Protein Dietary Supplement: Whey Protein and Resistance Exericse Other: Whey Protein and RISE exercise routine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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.
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.

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.
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.

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.
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.

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.




Primary Outcome Measures :
  1. change in visceral fat [ Time Frame: baseline and 17 weeks ]


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy, overweight or obese, inactive

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960335


Locations
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United States, New York
Health & Exercise Sciences Department, Human Nutrition and Metabolism Laboratory, Skidmore College
Saratoga Springs, New York, United States, 12866
Sponsors and Collaborators
Skidmore College
Investigators
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Principal Investigator: Paul J Arciero, Doctorate Skidmore College
Publications:
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Responsible Party: Paul Arciero, Professor, Health and Exercise Sciences Department, Director Human Nutrition and Metabolism Laboratory, Skidmore College
ClinicalTrials.gov Identifier: NCT01960335    
Other Study ID Numbers: whey-1001-192
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013
Keywords provided by Paul Arciero, Skidmore College:
whey protein intake
obesity
visceral fat
resistance exercise training
sprint interval training
endurance exercise training
yoga training
healthy eating
healthy lifestyle strategies
leptin
hunger
Additional relevant MeSH terms:
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Overweight
Body Weight