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Trial record 3 of 4 for:    9880251 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02333916
Recruitment Status : Terminated (Recruitment target could not be met)
First Posted : January 7, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Overfeeding and Exercise Other: overfeeding + exercise pre-training Behavioral: fitness training Other: overfeeding + exercise post-training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. Change in fat oxidation after training assessed in energy balance [ Time Frame: Baseline and 3 months ]
  10. Change in carbohydrate oxidation after training assessed in energy balance [ Time Frame: Baseline and 3 months ]
  11. 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.

  12. 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.

  13. 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)

  14. adipocyte size [ Time Frame: Baseline, 2 weeks (pre-training), 3 months (post-training) ]
    Fat biopsy taken these time points

  15. 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

  16. 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

  17. 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

  18. 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)

  19. 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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333916


Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6200
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Wim Saris, MD, PhD Maastricht University

Additional Information:
Publications:

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02333916     History of Changes
Other Study ID Numbers: NL47945.068.14
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: April 2015