Effect of Exercise and Training on Fat Oxidation During Overfeeding - the FeedEX Study (FeedEX)

September 22, 2015 updated by: Maastricht University Medical Center

Effects of Short-term Overfeeding With or Without Exercise on 24-hour Fat Oxidation and Fat Balance Before and After 10 Weeks of Training - The FeedEX Study

Rationale: Body weight is not well regulated in all individuals. In an obesogenic environment, where overeating is common, some individuals are more prone to weight gain and therefore overweight than others. Yet, the reasons behind this are unclear. "Resistant" individuals often have higher physical activity levels (PALs). It seems that - at higher levels of physical activity and therefore energy expenditure - satiety signals are more precisely regulated, making one better at matching energy intake with expenditure. In other words, active people may not overeat where sedentary people would. However, this does not explain the differences in weight gain observed when subjects all have to overeat (imposed overfeeding). It could be that active people are better able to cope metabolically with the extra calories because of already higher levels of carbohydrate and fat oxidation compared to their inactive counterparts.

Objectives: 1/ To study the effects of overfeeding (normal diet composition) on substrate balance and oxidation and more specifically fat balance and oxidation; 2/ to study the effects of exercise and training on fat oxidation during overfeeding (normal diet composition).

Study design: This controlled intervention study will follow a cross-over design. Each subject will spend 5 nights and 4 days in a respiration chamber on two occasions, separated by a 10-week training period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200
        • Maastricht University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Caucasians
  • Male
  • Healthy
  • 18-30 years
  • BMI 21-27.5 kg.m-2
  • Sedentary lifestyle: the following serve as (non-strict) guidelines: "Low category of activity" according to the short version of the International Physical Activity Questionnaire (IPAQ); VO2max (ml.kg-1.min-1) below: 45 - AGE (yrs) / 3 corresponding to a fitness category below "fair" (i.e. "poor" or "very poor") as defined by Schvartz and Reibold. For example for an 18 year-old male, VO2max below 39 ml.kg-1.min-1.
  • Stable body weight (<5% change in the last 6 months)

Exclusion Criteria:

  • Following a (weight-loss) diet
  • Using medications
  • Smoking
  • Consuming more than 3 units of alcohol per day
  • Diagnosed with any chronic diseases known to affect energy metabolism (intake/expenditure) such as diabetes, cardiovascular disease, cancer, or thyroid disease.
  • Trained or regularly physically active (according to the IPAQ)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Overfeeding + exercise pre/post training

overfeeding + exercise pre-training: day1 energy balance; day2 and day3: energy intake equals 1.25 times day 2 and day 3 energy expenditure respectively, no exercise; day4: 3 cycling bouts to expend 0.25 times day3 energy expenditure + energy intake equals 1.25 times day4 energy expenditure - before training period.

fitness training: 10-week training period (3 times per week at a gym, 30-45 minutes cardio training and 15-30 minutes strength training).

overfeeding + exercise post-training: day1 energy balance; day2 and day3: energy intake equals 1.25 times day 2 and day 3 energy expenditure respectively, no exercise; day4: 3 cycling bouts to expend 0.25 times day3 energy expenditure + energy intake equals 1.25 times day4 energy expenditure - after training period.
Other: overfeeding + exercise pre-training
Behavioral: fitness training
Other: overfeeding + exercise post-training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour fat balance with overfeeding after training
Time Frame: Baseline and 3 months
Day3 24-hour fat balance (calculated as the difference between metabolisable fat intake and fat oxidation measured by indirect calorimetry in respiration chamber) after training compared to baseline (=before training)
Baseline and 3 months
Change in 24-hour fat balance with overfeeding and exercise after training
Time Frame: Baseline and 3 months
Day4 24-hour fat balance (calculated as the difference between metabolisable fat intake and fat oxidation measured by indirect calorimetry in respiration chamber) after training compared to baseline (=before training)
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour fat oxidation with overfeeding and exercise in inactive men
Time Frame: Day 3 and day 4 (baseline stay in respiration chamber)
Fat oxidation measured by indirect calorimetry in respiration chamber on day 4 compared to day 3 at baseline
Day 3 and day 4 (baseline stay in respiration chamber)
Change in 24-hour carbohydrate oxidation with overfeeding and exercise in inactive men
Time Frame: Day 3 and day 4 (baseline stay in respiration chamber)
Carbohydrate oxidation measured by indirect calorimetry in respiration chamber on day 4 compared to day 3 at baseline
Day 3 and day 4 (baseline stay in respiration chamber)
Change in 24-hour fat balance with overfeeding and exercise in inactive men
Time Frame: Day 3 and day 4 (baseline stay in respiration chamber)
Fat balance (calculated as the difference between metabolisable fat intake and fat oxidation) on day 4 compared to day 3 at baseline
Day 3 and day 4 (baseline stay in respiration chamber)
Change in 24-hour fat oxidation with overfeeding and exercise in active men
Time Frame: Day 3 and day 4 (stay in respiration chamber at 3 months)
Fat oxidation measured by indirect calorimetry in respiration chamber on day 4 compared to day 3 after the training period
Day 3 and day 4 (stay in respiration chamber at 3 months)
Change in 24-hour carbohydrate oxidation with overfeeding and exercise in active men
Time Frame: Day 3 and day 4 (stay in respiration chamber at 3 months)
Carbohydrate oxidation measured by indirect calorimetry in respiration chamber on day 4 compared to day 3 after the training period
Day 3 and day 4 (stay in respiration chamber at 3 months)
Change in 24-hour fat balance with overfeeding and exercise in active men
Time Frame: Day 3 and day 4 (stay in respiration chamber at 3 months)
Fat balance (calculated as the difference between metabolisable fat intake and fat oxidation) on day 4 compared to day 3 after the training period
Day 3 and day 4 (stay in respiration chamber at 3 months)
Change in 24-hour carbohydrate oxidation with overfeeding after training
Time Frame: Baseline and 3 months
Day3 24-hour carbohydrate oxidation measured by indirect calorimetry in respiration chamber after training compared to baseline (=before training)
Baseline and 3 months
Change in 24-hour carbohydrate oxidation with overfeeding and exercise after training
Time Frame: Baseline and 3 months
Day4 24-hour carbohydrate oxidation measured by indirect calorimetry in respiration chamber after training compared to baseline (=before training)
Baseline and 3 months
Change in fat oxidation after training assessed in energy balance
Time Frame: Baseline and 3 months
Baseline and 3 months
Change in carbohydrate oxidation after training assessed in energy balance
Time Frame: Baseline and 3 months
Baseline and 3 months
Energy expenditure with overfeeding in inactive men
Time Frame: 4 days at baseline
Energy expenditure measured by indirect calorimetry during a 4-day stay in respiration chamber, with overfeeding on days 2 to 4.
4 days at baseline
Energy expenditure with overfeeding in active men
Time Frame: 4 days at 3 months
Energy expenditure measured by indirect calorimetry during a 4-day stay in respiration chamber, with overfeeding on days 2 to 4, after a 10-week fitness training.
4 days at 3 months
Insulin sensitivity
Time Frame: Baseline, 2 weeks (pre-training), 3 months (post-training)
Based on glucose and insulin plasma concentrations from oral glucose tolerance test, where blood is collected in fasted state at t=0, 30, 60, 90 and 120min after a glucose drink is ingested)
Baseline, 2 weeks (pre-training), 3 months (post-training)
adipocyte size
Time Frame: Baseline, 2 weeks (pre-training), 3 months (post-training)
Fat biopsy taken these time points
Baseline, 2 weeks (pre-training), 3 months (post-training)
Genes involved in lipid metabolism
Time Frame: Baseline, 2 weeks (pre-training), 3 months (post-training)
Using fat biopsies: analysis of genes involved in the lipolytic pathway [ATGL (PNPLA2), HSL (S660/565/563), CGI-58, G0S2, PLIN1, AQP7, GK], in insulin signaling/glucose metabolism [GLUT4, IRS1/IRS2, AKT, pAKT (S473), pIRS1 (S1101)], in fatty acid metabolism [CD36, FABP4 (aP2), FASN, CPT1a/1b, CPT2, ACADL/ACADVL/ACADS/ACADM, ACOX1, OXPHOS (complex I-V), PPAR(α/βδ/γ), PGC1a, PGC1b, SIRT1, AMPK (pAMPK)], and in DAG/ceramide metabolism [DGAT 1/2, GPAT1/GPAM, PLC, SPTLC1 and SPTLC2, CERK, ASAH1 and ASAH2
Baseline, 2 weeks (pre-training), 3 months (post-training)
Change in body composition
Time Frame: Baseline and 3 months
Measured using body weight, underwater weighing and deuterium dilution, before and after the fitness training
Baseline and 3 months
Change in cardiorespiratory fitness
Time Frame: Baseline, after 6-7 weeks of training and 3 months
Cardiorespiratory fitness estimated as the maximal oxygen uptake (VO2max) assessed using an incremental test on a bicycle ergometer
Baseline, after 6-7 weeks of training and 3 months
Change in energy expenditure in free-living conditions
Time Frame: Baseline and 3 months
Energy expenditure measured over 14 days using doubly-labeled water and two accelerometers (TracmorD and Actigraph GT3X)
Baseline and 3 months
Validity of Actigraph GT3X accelerometer
Time Frame: Two 14-day periods (baseline and 3 months)
The Actigraph GT3X accelerometer is worn by each subject twice for 14 days and will be validated against the doubly labeled water technique and compared to the tracmorD accelerometer
Two 14-day periods (baseline and 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Wim Saris, MD, PhD, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 30, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • NL47945.068.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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