Clinical trial NCT02333916: Effect of Exercise and Training on Fat Oxidation During Overfeeding - the FeedEX Study
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overfeeding and Exercise
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Change in 24-hour fat balance with overfeeding after training
timeFrame: Baseline and 3 months
measure: Change in 24-hour fat balance with overfeeding and exercise after training
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in 24-hour fat oxidation with overfeeding and exercise in inactive men
timeFrame: Day 3 and day 4 (baseline stay in respiration chamber)
measure: Change in 24-hour carbohydrate oxidation with overfeeding and exercise in inactive men
timeFrame: Day 3 and day 4 (baseline stay in respiration chamber)
measure: Change in 24-hour fat balance with overfeeding and exercise in inactive men
timeFrame: Day 3 and day 4 (baseline stay in respiration chamber)
measure: Change in 24-hour fat oxidation with overfeeding and exercise in active men
timeFrame: Day 3 and day 4 (stay in respiration chamber at 3 months)
measure: Change in 24-hour carbohydrate oxidation with overfeeding and exercise in active men
timeFrame: Day 3 and day 4 (stay in respiration chamber at 3 months)
measure: Change in 24-hour fat balance with overfeeding and exercise in active men
timeFrame: Day 3 and day 4 (stay in respiration chamber at 3 months)
measure: Change in 24-hour carbohydrate oxidation with overfeeding after training
timeFrame: Baseline and 3 months
measure: Change in 24-hour carbohydrate oxidation with overfeeding and exercise after training
timeFrame: Baseline and 3 months
measure: Change in fat oxidation after training assessed in energy balance
timeFrame: Baseline and 3 months
measure: Change in carbohydrate oxidation after training assessed in energy balance
timeFrame: Baseline and 3 months
measure: Energy expenditure with overfeeding in inactive men
timeFrame: 4 days at baseline
measure: Energy expenditure with overfeeding in active men
timeFrame: 4 days at 3 months
measure: Insulin sensitivity
timeFrame: Baseline, 2 weeks (pre-training), 3 months (post-training)
measure: adipocyte size
timeFrame: Baseline, 2 weeks (pre-training), 3 months (post-training)
measure: Genes involved in lipid metabolism
timeFrame: Baseline, 2 weeks (pre-training), 3 months (post-training)
measure: Change in body composition
timeFrame: Baseline and 3 months
measure: Change in cardiorespiratory fitness
timeFrame: Baseline, after 6-7 weeks of training and 3 months
measure: Change in energy expenditure in free-living conditions
timeFrame: Baseline and 3 months
measure: Validity of Actigraph GT3X accelerometer
timeFrame: Two 14-day periods (baseline and 3 months)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Wim Saris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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