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

NCT ID: NCT01830946

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

Whey Protein

Intervention Type OTHER

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 training

Intervention Type OTHER

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.

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).

Group Type PLACEBO_COMPARATOR

Combined Resistance and High-Intensity Interval training

Intervention Type OTHER

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 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).

Group Type EXPERIMENTAL

Combined Resistance and High-Intensity Interval training

Intervention Type OTHER

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 Protein

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Florida State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael J. Ormsbee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael J Ormsbee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida State University

Tallahassee, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25409324 (View on PubMed)

Figueroa 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.

Reference Type DERIVED
PMID: 24300595 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC2011.7210

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Resistance Training in Elderly
NCT00744094 COMPLETED PHASE1/PHASE2