NCT01830946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

April 10, 2013

Last Update Submit

April 11, 2013

Conditions

Keywords

ProteinMetabolismNighttime eatingExercise Training

Outcome Measures

Primary Outcomes (2)

  • Body Composition

    Measuring fat mass and lean mass from dual-energy x-ray absorptiometry.

    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

    4 weeks

Secondary Outcomes (4)

  • Blood biomarkers

    4 weeks

  • Arterial Stiffness

    4 weeks

  • Appetite

    4 weeks

  • Strength

    4 weeks

Study Arms (3)

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).

Other: Whey ProteinOther: 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).

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).

Other: Combined Resistance and High-Intensity Interval trainingOther: Casein Protein

Interventions

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.

Whey Protein and Exercise 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.

Carbohydrate and Exercise TrainingCasein Protein and Exercise TrainingWhey Protein and Exercise Training

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.

Casein Protein and Exercise Training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Obesity

Interventions

Whey ProteinsHigh-Intensity Interval Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michael J Ormsbee, Ph.D.

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

September 1, 2011

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations