Overfeeding and Exercise Clinical Trial
— FeedEXOfficial 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
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 30 Years |
| Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,
Blaak EE, Hul G, Verdich C, Stich V, Martinez A, Petersen M, Feskens EF, Patel K, Oppert JM, Barbe P, Toubro S, Anderson I, Polak J, Astrup A, Macdonald IA, Langin D, Holst C, Sørensen TI, Saris WH. Fat oxidation before and after a high fat load in the obese insulin-resistant state. J Clin Endocrinol Metab. 2006 Apr;91(4):1462-9. Epub 2006 Jan 31. — View Citation
Blair SN, Brodney S. Effects of physical inactivity and obesity on morbidity and mortality: current evidence and research issues. Med Sci Sports Exerc. 1999 Nov;31(11 Suppl):S646-62. — View Citation
Bouchard C, Tremblay A, Després JP, Nadeau A, Lupien PJ, Thériault G, Dussault J, Moorjani S, Pinault S, Fournier G. The response to long-term overfeeding in identical twins. N Engl J Med. 1990 May 24;322(21):1477-82. — View Citation
Diaz EO, Prentice AM, Goldberg GR, Murgatroyd PR, Coward WA. Metabolic response to experimental overfeeding in lean and overweight healthy volunteers. Am J Clin Nutr. 1992 Oct;56(4):641-55. — View Citation
Hagobian TA, Braun B. Interactions between energy surplus and short-term exercise on glucose and insulin responses in healthy people with induced, mild insulin insensitivity. Metabolism. 2006 Mar;55(3):402-8. — View Citation
Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation. 2012 Jul 3;126(1):126-32. doi: 10.1161/CIRCULATIONAHA.111.087213. Review. — View Citation
Horton TJ, Drougas H, Brachey A, Reed GW, Peters JC, Hill JO. Fat and carbohydrate overfeeding in humans: different effects on energy storage. Am J Clin Nutr. 1995 Jul;62(1):19-29. — View Citation
Jebb SA, Prentice AM, Goldberg GR, Murgatroyd PR, Black AE, Coward WA. Changes in macronutrient balance during over- and underfeeding assessed by 12-d continuous whole-body calorimetry. Am J Clin Nutr. 1996 Sep;64(3):259-66. — View Citation
Joosen AM, Bakker AH, Westerterp KR. Metabolic efficiency and energy expenditure during short-term overfeeding. Physiol Behav. 2005 Aug 7;85(5):593-7. — View Citation
Joosen AM, Bakker AH, Zorenc AH, Kersten S, Schrauwen P, Westerterp KR. PPARgamma activity in subcutaneous abdominal fat tissue and fat mass gain during short-term overfeeding. Int J Obes (Lond). 2006 Feb;30(2):302-7. — View Citation
Knudsen SH, Hansen LS, Pedersen M, Dejgaard T, Hansen J, Hall GV, Thomsen C, Solomon TP, Pedersen BK, Krogh-Madsen R. Changes in insulin sensitivity precede changes in body composition during 14 days of step reduction combined with overfeeding in healthy young men. J Appl Physiol (1985). 2012 Jul;113(1):7-15. doi: 10.1152/japplphysiol.00189.2011. Epub 2012 May 3. Erratum in: J Appl Physiol (1985). 2015 Feb 15;118(4):504. — View Citation
Lammert O, Grunnet N, Faber P, Bjørnsbo KS, Dich J, Larsen LO, Neese RA, Hellerstein MK, Quistorff B. Effects of isoenergetic overfeeding of either carbohydrate or fat in young men. Br J Nutr. 2000 Aug;84(2):233-45. — View Citation
Levine JA, Eberhardt NL, Jensen MD. Role of nonexercise activity thermogenesis in resistance to fat gain in humans. Science. 1999 Jan 8;283(5399):212-4. — View Citation
MAYER J, ROY P, MITRA KP. Relation between caloric intake, body weight, and physical work: studies in an industrial male population in West Bengal. Am J Clin Nutr. 1956 Mar-Apr;4(2):169-75. — View Citation
Norgan NG, Durnin JV. The effect of 6 weeks of overfeeding on the body weight, body composition, and energy metabolism of young men. Am J Clin Nutr. 1980 May;33(5):978-88. — View Citation
Plasqui G, Joosen AM, Kester AD, Goris AH, Westerterp KR. Measuring free-living energy expenditure and physical activity with triaxial accelerometry. Obes Res. 2005 Aug;13(8):1363-9. — View Citation
Schokker DF, Visscher TL, Nooyens AC, van Baak MA, Seidell JC. Prevalence of overweight and obesity in the Netherlands. Obes Rev. 2007 Mar;8(2):101-8. — View Citation
Speakman JR. The history and theory of the doubly labeled water technique. Am J Clin Nutr. 1998 Oct;68(4):932S-938S. Review. — View Citation
Walhin JP, Richardson JD, Betts JA, Thompson D. Exercise counteracts the effects of short-term overfeeding and reduced physical activity independent of energy imbalance in healthy young men. J Physiol. 2013 Dec 15;591(24):6231-43. doi: 10.1113/jphysiol.2013.262709. Epub 2013 Oct 28. — View Citation
* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in 24-hour fat balance with overfeeding after training | 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 | No |
| Primary | Change in 24-hour fat balance with overfeeding and exercise after training | 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 | No |
| Secondary | Change in 24-hour fat oxidation with overfeeding and exercise in inactive men | 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) | No |
| Secondary | Change in 24-hour carbohydrate oxidation with overfeeding and exercise in inactive men | 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) | No |
| Secondary | Change in 24-hour fat balance with overfeeding and exercise in inactive men | 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) | No |
| Secondary | Change in 24-hour fat oxidation with overfeeding and exercise in active men | 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) | No |
| Secondary | Change in 24-hour carbohydrate oxidation with overfeeding and exercise in active men | 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) | No |
| Secondary | Change in 24-hour fat balance with overfeeding and exercise in active men | 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) | No |
| Secondary | Change in 24-hour carbohydrate oxidation with overfeeding after training | Day3 24-hour carbohydrate oxidation measured by indirect calorimetry in respiration chamber after training compared to baseline (=before training) | Baseline and 3 months | No |
| Secondary | Change in 24-hour carbohydrate oxidation with overfeeding and exercise after training | Day4 24-hour carbohydrate oxidation measured by indirect calorimetry in respiration chamber after training compared to baseline (=before training) | Baseline and 3 months | No |
| Secondary | Change in fat oxidation after training assessed in energy balance | Baseline and 3 months | No | |
| Secondary | Change in carbohydrate oxidation after training assessed in energy balance | Baseline and 3 months | No | |
| Secondary | Energy expenditure with overfeeding in inactive men | 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 | No |
| Secondary | Energy expenditure with overfeeding in active men | 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 | No |
| Secondary | Insulin sensitivity | 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) | No |
| Secondary | adipocyte size | Fat biopsy taken these time points | Baseline, 2 weeks (pre-training), 3 months (post-training) | No |
| Secondary | Genes involved in lipid metabolism | 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(a/ßd/?), 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) | No |
| Secondary | Change in body composition | Measured using body weight, underwater weighing and deuterium dilution, before and after the fitness training | Baseline and 3 months | No |
| Secondary | Change in cardiorespiratory fitness | 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 | No |
| Secondary | Change in energy expenditure in free-living conditions | Energy expenditure measured over 14 days using doubly-labeled water and two accelerometers (TracmorD and Actigraph GT3X) | Baseline and 3 months | No |
| Secondary | Validity of Actigraph GT3X accelerometer | 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) | No |