Clinical trial NCT01830946: Nighttime Macronutrient Choice and Combined Resistance and High-intensity Interval Training
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Protein
Metabolism
Nighttime eating
Exercise Training
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Body Composition
timeFrame: 4 weeks
measure: Metabolism
timeFrame: 4 weeks
Secondary outcomes:
measure: Blood biomarkers
timeFrame: 4 weeks
measure: Arterial Stiffness
timeFrame: 4 weeks
measure: Appetite
timeFrame: 4 weeks
measure: Strength
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Michael J Ormsbee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.