NCT01960335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

October 5, 2013

Last Update Submit

October 9, 2013

Conditions

Keywords

whey protein intakeobesityvisceral fatresistance exercise trainingsprint interval trainingendurance exercise trainingyoga traininghealthy eatinghealthy lifestyle strategiesleptinhunger

Outcome Measures

Primary Outcomes (1)

  • change in visceral fat

    baseline and 17 weeks

Study Arms (3)

Whey Protein Only

ACTIVE COMPARATOR

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 and Resistance Exericse

EXPERIMENTAL

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 ProteinDietary Supplement: Whey Protein and Resistance Exericse

Whey Protein and RISE exercise routine

EXPERIMENTAL

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 ProteinOther: Whey Protein and RISE exercise routine

Interventions

Whey ProteinDIETARY_SUPPLEMENT

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 OnlyWhey Protein and RISE exercise routineWhey 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.

Whey Protein and Resistance Exericse

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.

Whey Protein and RISE exercise routine

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy, overweight or obese, inactive

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Saratoga Springs, New York, 12866, United States

Location

Related 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.

    PMID: 21677076BACKGROUND

MeSH Terms

Conditions

ObesityOverweight

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Paul J Arciero, Doctorate

    Skidmore College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Health and Exercise Sciences Department, Director Human Nutrition and Metabolism Laboratory

Study Record Dates

First Submitted

October 5, 2013

First Posted

October 10, 2013

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

September 1, 2012

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations