An interventional study of Whey Protein and exercise training and Food Protein and exercise training in Physical Performance, sponsored by Skidmore College. Completed. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by Skidmore College · Not applicable and Interventional
A primary aim of the current proposal is to compare the effect of daily consumption of healthy lean protein as either whey protein (2 meals per day) or whole food (25% of total daily caloric intake) consumed as 6 small meals throughout the day, one of which is consumed immediately following exercise training (within 30 min) and another 2 hours prior to going to bed at night, over a 16 week period on muscle and fat mass, cardiovascular health, aerobic fitness, glucose, insulin, blood lipids, heart rate and muscle strength in overweight men and women.
The primary purpose of this study is to examine the effects of increased healthy protein intake (25% of daily caloric intake as protein; 25% as healthy fats and oils; 50% as complex, unrefined carbohydrates) consumed as 6 small meals during the day in combination with exercise training 4 times per week, over a 16 week period in 25 overweight, but healthy males and females (30-60 yrs old). A secondary purpose is to compare the effects of consuming two of the 6 small meals during the day comprised of whole food protein source servings 20g/serving) with a matched group consuming whey protein for 2 daily protein servings (20g/serving). In the case of both groups, 1 serving will be consumed immediately following exercise [within 30 minutes] and 1 serving will be consumed 2 hours before going to bed. On non-exercise days, all participants will continue to consume 6 small meals per day in the same ratio of 25% lean protein, 25% healthy fats and oils, and 50% complex, unrefined carbohydrates but the groups will differ only in the composition of the last meal of the day consumed 2 hours before going to bed in which one group will consume protein (20g/serving) as whole food protein sources and the other group will consume a single serving of a whey protein supplement. The primary purpose of this study is to quantify changes in the following health outcomes at baseline and 16 weeks: total body muscle mass and fat mass (iDXA); abdominal fat mass (most highly related to cardiovascular and metabolic disease risk); blood sugar (glucose); blood lipids; insulin, aerobic fitness (assessed with a submaximal exercise test); and muscular strength (measured by 1 repetition maximum (RM) of the chest and leg press). The following additional measures will be assessed at baseline and 16 weeks: waist circumference; body weight, heart rate, blood pressure, and hunger (Visual Analog Scales).
Skidmore College is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Six meals per day of 20 grams of protein, two of which were whey protein and 4 days per week of exercise training..
Behavioral: Whey Protein and exercise training
Six meals per day of 20 grams of protein, all of which were whole food protein and 4 days per week of exercise training.
Behavioral: Food Protein and exercise training
Six meals per day four of which were whole food and two of whey protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training
Six meals per day all of which were whole food protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training
Athletic Performance
Changes in one repetition maximum muscular strength of upper and lower body
Time frame: baseline and post 16 week intervention
Total and Regional Body Composition
Changes in total and regional body fat assessed by dual energy xray
Time frame: baseline and post 16 week intervention
Cardiometabolic Hormones
Changes in plasma insulin levels
Time frame: baseline and post 16 week intervention
Aerobic Fitness
Changes in oxygen consumption
Time frame: baseline and post 12 week intervention
Hunger Ratings
Changes in hunger visual analog scale ratings
Time frame: baseline and post 12 week intervention
Blood Lipids
Changes in total, LDL, HDL cholesterol
Time frame: baseline and post 12 week intervention
Blood Pressure
Changes in systolic and diastolic blood pressure
Time frame: baseline and post 12 week intervention
No study locations are listed for this record.
The record gives a start of Dec 2010, a primary completion of Jun 2011 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Skidmore College