ObesityNCT01830946
Nighttime Macronutrient Choice and Combined Resistance and High-intensity Interval Training
A study testing Whey Protein, Combined Resistance and High-Intensity Interval training and Casein Protein in people with Obesity, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Whey Protein, Combined Resistance and High-Intensity Interval training and Casein Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Whey Protein, Combined Resistance and High-Intensity Interval training, Casein Protein
- Keywords
- Protein, Metabolism, Nighttime eating, Exercise Training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinOther
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.
Combined Resistance and High-Intensity Interval trainingOther
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.
Casein ProteinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein and Exercise Training | Experimental | 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). Receives: Other: Whey Protein; Other: Combined Resistance and High-Intensity Interval training |
| Carbohydrate and Exercise Training | Placebo comparator | 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). Receives: Other: Combined Resistance and High-Intensity Interval training |
| Casein Protein and Exercise Training | Experimental | 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). Receives: Other: Combined Resistance and High-Intensity Interval training; Other: Casein Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
Measuring fat mass and lean mass from dual-energy x-ray absorptiometry.
Measured: 4 weeks
Metabolism
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
Measured: 4 weeks
Secondary outcomes (4)
Blood biomarkers
Under sterile conditions 20 milliliters of blood was drawn from a forearm antecubital vein and analyzed for blood biomarkers.
Measured: 4 weeks
Arterial Stiffness
Measured using pulse wave velocity of the aorta, systemic, and legs
Measured: 4 weeks
Appetite
Measured by a visual analog scale
Measured: 4 weeks
Strength
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Ormsbee, Florida State University
- Investigators
- Michael J Ormsbee, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830946
- Sponsor's protocol ID
- HSC2011.7210
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ormsbee MJ, Kinsey AW, Eddy WR, Madzima TA, Arciero PJ, Figueroa A, Panton LB. The influence of nighttime feeding of carbohydrate or protein combined with exercise training on appetite and cardiometabolic risk in young obese women. Appl Physiol Nutr Metab. 2015 Jan;40(1):37-45. doi: 10.1139/apnm-2014-0256.
PubMed 25409324Figueroa A, Wong A, Kinsey A, Kalfon R, Eddy W, Ormsbee MJ. Effects of milk proteins and combined exercise training on aortic hemodynamics and arterial stiffness in young obese women with high blood pressure. Am J Hypertens. 2014 Mar;27(3):338-44. doi: 10.1093/ajh/hpt224. Epub 2013 Dec 3.
PubMed 24300595
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01830946
- Acronym / sponsor ID
- HSC2011.7210
- Conditions
- Obesity
- Keywords
- Protein, Metabolism, Nighttime eating, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey Protein and Exercise Training | Experimental | Other: Whey Protein, Other: Combined Resistance and High-Intensity Interval trainingThis 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). |
| Carbohydrate and Exercise Training | Placebo comparator | Other: Combined Resistance and High-Intensity Interval trainingThis 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). |
| Casein Protein and Exercise Training | Experimental | Other: Combined Resistance and High-Intensity Interval training, Other: Casein ProteinThis 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey ProteinWhey 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 | Whey Protein and Exercise Training |
| Combined Resistance and High-Intensity Interval trainingCompleted 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 | Carbohydrate and Exercise Training, Casein Protein and Exercise Training, Whey Protein and Exercise Training |
| Casein ProteinCasein 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 | Casein Protein and Exercise Training |
Primary outcome
Body Composition
Time frame: 4 weeks
Measuring fat mass and lean mass from dual-energy x-ray absorptiometry.
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
4 secondary outcomes
Blood biomarkers
Time frame: 4 weeks
Arterial Stiffness
Time frame: 4 weeks
Appetite
Time frame: 4 weeks
Strength
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- Derived from this study: PubMed 25409324Ormsbee MJ, Kinsey AW, Eddy WR, Madzima TA, Arciero PJ, Figueroa A, Panton LB. The influence of nighttime feeding of carbohydrate or protein combined with exercise training on appetite and cardiometabolic risk in young obese women. Appl Physiol Nutr Metab. 2015 Jan;40(1):37-45. doi: 10.1139/apnm-2014-0256.
- Derived from this study: PubMed 24300595Figueroa A, Wong A, Kinsey A, Kalfon R, Eddy W, Ormsbee MJ. Effects of milk proteins and combined exercise training on aortic hemodynamics and arterial stiffness in young obese women with high blood pressure. Am J Hypertens. 2014 Mar;27(3):338-44. doi: 10.1093/ajh/hpt224. Epub 2013 Dec 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Ormsbee, Ph.D. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein, Combined Resistance and High-Intensity Interval training and Casein Protein in people with Obesity, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01830946, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.