ClinicalTrials.gov
ClinicalTrials.gov Menu

Nighttime Macronutrient Choice and Combined Resistance and High-intensity Interval Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01830946
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
Michael J. Ormsbee, Florida State University

Brief Summary:

Obesity is recognized as a major public health concern because of its link to potential fatal complications arising from metabolic and cardiovascular diseases. Despite many pharmacological advances in this field, lifestyle strategies that emphasize proper nutrient intake and physical activity continue to be the primary strategy for individuals to fight obesity. However, controversy exists regarding the type and timing of exercise and specific nutrient intake to maximize fat loss, muscle gain, and beneficial cardio-metabolic adaptations derived from these lifestyle interventions. Furthermore, limited data exists investigating the impact of nutrient timing at times other than immediately before or after exercise and no studies have examined time-of-day nutritional intake in overweight or obese individuals.In addition, many individuals attempting to improve body composition and cardio-metabolic health are concerned with what food choices are appropriate in the late evening to support positive physiological adaptations. However, research-based information examining this topic is scarce.

The investigators hypothesize that consumption of a protein beverage in the late evening before sleep will improve body composition, cardio-metabolic health, and adaptations to exercise more than an isocaloric placebo beverage. The investigators also hypothesize that the different digestion and absorption kinetics of whey and casein proteins will elicit different effects on the measures variables.


Condition or disease Intervention/treatment Phase
Obesity Other: Whey Protein Other: Combined Resistance and High-Intensity Interval training Other: Casein Protein Not Applicable

Detailed Description:

The purpose of this study is to examine the effect of consumption of a protein beverage in the late evening before sleep along with the combination of resistance and high-intensity interval training on improving body composition, muscle strength and overall health compared to a carbohydrate placebo beverage in overweight and obese individuals. Specifically, we will be measuring heart rate, blood pressure, body composition, resting metabolism, maximal strength,cardiovascular function, hormones levels, blood lipid profile, appetite, mood state, and dietary intake. Specific aims of the study are:

To determine if acute ingestion of a liquid ready-to-drink protein supplement (30g whey or casein protein per serving) consumed in the late evening before sleep will alter the physiological milieu to favor anabolism and alter lipolysis and fat oxidation more than the carbohydrate placebo (34g of maltodextrin per serving).

To determine if 4 weeks of daily protein supplementation (same supplement as above) in the late evening along with 3 days of exercise training per week will improve body composition, blood lipid profile, strength, cardiovascular risk profile more than a placebo beverage.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Nighttime Macronutrient Choice and Combined Resistance and High-Intensity Interval Training on Body Composition, Cardiovascular Health, Resting Metabolism, Appetite and Strength in Overweight and Obese Adults
Study Start Date : September 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Experimental: Whey Protein and Exercise Training
This arm involves 4 weeks of consuming a whey protein supplement late in the evening before bed along with combined resistance and high-intensity interval training 3 days per week for 4 weeks (two days of resistance training and one day of high-intensity interval training).
Other: Whey Protein
Whey protein will be consumed every night of the week as the last food or caloric beverage prior to sleep in the evening at least two hours after dinner but no more than 30 minutes before bed.

Other: Combined Resistance and High-Intensity Interval training
Completed 3 d/wk for 4 wks (2 d of Resistance Training (RT) and 1 d of High-Intensity Interval Training (HITT)). RT exercises were chest press, seated row,leg press, shoulder press, leg extension, and leg curl (3 total sets: 2 sets of 10 repetitions and a 3rd set to muscular exhaustion with a load equaling 75-85% of 1-Repetition Maximum(RM)). All exercises and sets were separated by 90-120 sec of rest. HIIT training was completed on commerical cardiovascular equipment and requires subjects to rate their perceived exertion on a scale from 1 to 10 (1= resting quietly, 5= a warm-up level, 10= an all-out exertion). Subjects warmed-up for 2 min at level 5 and increased their exertion each min for 3 min until level 9 is perceived and then recover at level 6 for 1 min. This pattern was repeated 4 times, where the 4th cycle subjects increased their last min of exertion to level 10, followed by 1-min recovery at the initial warm-up level 5.

Placebo Comparator: Carbohydrate and Exercise Training
This arm involves 4 weeks of consuming a carbohydrate placebo late in the evening before bed along with combined resistance and high-intensity interval training 3 days per week for 4 weeks (two days of resistance training and one day of high-intensity interval training).
Other: Combined Resistance and High-Intensity Interval training
Completed 3 d/wk for 4 wks (2 d of Resistance Training (RT) and 1 d of High-Intensity Interval Training (HITT)). RT exercises were chest press, seated row,leg press, shoulder press, leg extension, and leg curl (3 total sets: 2 sets of 10 repetitions and a 3rd set to muscular exhaustion with a load equaling 75-85% of 1-Repetition Maximum(RM)). All exercises and sets were separated by 90-120 sec of rest. HIIT training was completed on commerical cardiovascular equipment and requires subjects to rate their perceived exertion on a scale from 1 to 10 (1= resting quietly, 5= a warm-up level, 10= an all-out exertion). Subjects warmed-up for 2 min at level 5 and increased their exertion each min for 3 min until level 9 is perceived and then recover at level 6 for 1 min. This pattern was repeated 4 times, where the 4th cycle subjects increased their last min of exertion to level 10, followed by 1-min recovery at the initial warm-up level 5.

Experimental: Casein Protein and Exercise Training
This arm involves 4 weeks of consuming a casein protein supplement late in the evening before bed along with combined resistance and high-intensity interval training 3 days per week for 4 weeks (two days of resistance training and one day of high-intensity interval training).
Other: Combined Resistance and High-Intensity Interval training
Completed 3 d/wk for 4 wks (2 d of Resistance Training (RT) and 1 d of High-Intensity Interval Training (HITT)). RT exercises were chest press, seated row,leg press, shoulder press, leg extension, and leg curl (3 total sets: 2 sets of 10 repetitions and a 3rd set to muscular exhaustion with a load equaling 75-85% of 1-Repetition Maximum(RM)). All exercises and sets were separated by 90-120 sec of rest. HIIT training was completed on commerical cardiovascular equipment and requires subjects to rate their perceived exertion on a scale from 1 to 10 (1= resting quietly, 5= a warm-up level, 10= an all-out exertion). Subjects warmed-up for 2 min at level 5 and increased their exertion each min for 3 min until level 9 is perceived and then recover at level 6 for 1 min. This pattern was repeated 4 times, where the 4th cycle subjects increased their last min of exertion to level 10, followed by 1-min recovery at the initial warm-up level 5.

Other: Casein Protein
Casein protein will be consumed every night of the week as the last food or caloric beverage prior to sleep in the evening at least two hours after dinner but no more than 30 minutes before bed.




Primary Outcome Measures :
  1. Body Composition [ Time Frame: 4 weeks ]
    Measuring fat mass and lean mass from dual-energy x-ray absorptiometry.

  2. Metabolism [ Time Frame: 4 weeks ]
    Measured using indirect calorimetry, a non-invasive test that involves lying down on a padded table for 30-minutes with a mouth piece and nose clip


Secondary Outcome Measures :
  1. Blood biomarkers [ Time Frame: 4 weeks ]
    Under sterile conditions 20 milliliters of blood was drawn from a forearm antecubital vein and analyzed for blood biomarkers.

  2. Arterial Stiffness [ Time Frame: 4 weeks ]
    Measured using pulse wave velocity of the aorta, systemic, and legs

  3. Appetite [ Time Frame: 4 weeks ]
    Measured by a visual analog scale

  4. Strength [ Time Frame: 4 weeks ]
    Assessed by having the subject progressed towards the maximum weight that they can lift 1-time through a full range of motion and all attempts and will be supervised by trained personnel



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women
  • Sedentary(exercises <2 days per week for more than 40 minutes per session within the past 6 months)
  • overweight or obese (BMI ≥ 25)

Exclusion Criteria:

  • Those that exercise for more than 2 days per week for more than 40 minutes per session (within the past 6 months),
  • Those that have uncontrolled hypertension (Blood Pressure (BP)>160/100 mmHg)
  • Those that take BP medications
  • Those diagnosed cardiovascular disease
  • Those diagnosed with stroke
  • Those diagnosed with diabetes
  • Those diagnosed with thyroid dysfunction
  • Those diagnosed with kidney dysfunction
  • Those with any musculoskeletal complications that would impede exercise
  • Those that smoke heavily (>20 cigarettes per day)
  • Those that take cholesterol medication
  • Those that take nutritional supplements (except for a multivitamin)
  • Those with any allergies to milk products

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): NCT01830946


Locations
United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Investigators
Principal Investigator: Michael J Ormsbee, Ph.D. Florida State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael J. Ormsbee, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier: NCT01830946     History of Changes
Other Study ID Numbers: HSC2011.7210
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by Michael J. Ormsbee, Florida State University:
Protein
Metabolism
Nighttime eating
Exercise Training

Additional relevant MeSH terms:
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action