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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960335
• Other study ID #: whey-1001-192
• Status: Completed
• Phase: N/A
• First received: October 5, 2013
• Last updated: October 9, 2013
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2013
• Source: Skidmore College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy, overweight or obese, inactive

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Health & Exercise Sciences Department, Human Nutrition and Metabolism Laboratory, Skidmore College	Saratoga Springs	New York

Sponsors (1)

Lead Sponsor	Collaborator
Skidmore College

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in visceral fat		baseline and 17 weeks