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

Sponsor

Skidmore College (Other)

Overall Status

Completed

CT.gov ID

NCT01960335

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

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 :

Jan 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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.

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

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

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.

Outcome Measures

Primary Outcome Measures

change in visceral fat [baseline and 17 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy, overweight or obese, inactive

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health & Exercise Sciences Department, Human Nutrition and Metabolism Laboratory, Skidmore College	Saratoga Springs	New York	United States	12866

Sponsors and Collaborators

Skidmore College

Investigators

Principal Investigator: Paul J Arciero, Doctorate, Skidmore College

Study Documents (Full-Text)

None provided.

More Information

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.

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:

Oct 10, 2013

Last Update Posted:

Oct 10, 2013

Last Verified:

Oct 1, 2013

Keywords provided by Paul Arciero, Professor, Health and Exercise Sciences Department, Director Human Nutrition and Metabolism Laboratory, 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:

Overweight

Study Results

No Results Posted as of Oct 10, 2013