NCT02211391

Brief Summary

Single macronutrients will be consumed before sleep by obese men. Overnight lipolysis will be measured with the microdialysis technique by measuring glycerol concentration and blood flow in abdominal adipose tissue. Morning fat oxidation will be measured with indirect calorimetry. The investigators hypothesize that carbohydrate intake will blunt the overnight lipolysis rate compared to casein protein and a non-caloric placebo. The investigators also hypothesize that casein and placebo will not be significantly different from each other in terms of overnight lipolysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1.1 years

First QC Date

August 4, 2014

Last Update Submit

August 10, 2015

Conditions

Obesity

Keywords

Nighttime EatingProteinObesityLipolysisMetabolism

Outcome Measures

Primary Outcomes (1)

  • Lipolysis

    Measuring lipolysis using the microdialysis technique. Samples will be collected at various time intervals Vial 1: 30 minute; 2.0 uL/min flow rate Vial 2: 4 hours; 0.3 uL/min flow rate Vial 3: Overnight; 0.3 uL/min flow rate (before taking nighttime supplement) Vial 4: Morning sample #1; 2.0 uL/min flow rate (upon waking) Vial 5: Morning sample #2; 2.0 uL/min flow rate (arrive to lab) Blood flow will be measured using the Ethanol technique

    Change from day 1 to day 2 to day 3 of testing

Secondary Outcomes (1)

  • Resting Metabolic Rate (RMR)

    Change from day 1 to day 2 to day 3

Other Outcomes (2)

  • Appetite

    Change from Baseline to day 1, 2, and 3

  • Blood hormones

    Change from Baseline to day 1, 2, and 3

Study Arms (2)

Casein Protein

EXPERIMENTAL

Casein protein (30g) will be consumed as the last food/caloric beverage and within 30 minute of sleep

Other: Casein Protein

Non-caloric Placebo

PLACEBO COMPARATOR

The non-caloric placebo beverage will will be consumed as the last food/caloric beverage and within 30 minute of sleep

Other: Non-caloric placebo

Interventions

Casein ProteinOTHER

The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined

Casein Protein
Non-caloric placeboOTHER

The effect of a non-caloric placebo consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined

Non-caloric Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy, sedentary overweight or obese (BMI ≥25 kg/m\^2; body fat ≥ 25% ) men

You may not qualify if:

  • Men that have been exercising for more than 2 days per week for more than 45 minutes per session (within the past 6 months), have uncontrolled hypertension (Blood Pressure (BP)\>160/100 mmHg, diagnosed cardiovascular disease, stroke, diabetes, thyroid or kidney dysfunction, take cholesterol medication, or have any allergies to milk products will be excluded. Smokers will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Science and Medicine, Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael J Ormsbee, PhD

    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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 7, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(1)