Skip to main content
OpenTrials
Completed

NCT Number: NCT01830946

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey Protein

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

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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2013
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.