Overfeeding and ExerciseFeedEXNCT02333916

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

A study testing overfeeding + exercise pre-training, fitness training and overfeeding + exercise post-training in people with Overfeeding and Exercise, run by Maastricht University Medical Center at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for: Overfeeding and Exercise
What is being tested?: overfeeding + exercise pre-training, fitness training and overfeeding + exercise post-training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteNetherlands
Study dates: Jun 2014to Apr 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Maastricht University
Maastricht, Limburg, 6200

Other trials in Netherlands

About this 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

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.

Conditions: Overfeeding and Exercise
Being tested: overfeeding + exercise pre-training, fitness training, overfeeding + exercise post-training
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

overfeeding + exercise pre-trainingOther
fitness trainingBehavioural
overfeeding + exercise post-trainingOther

Study groups in NCT02333916
Study group	Role	What they receive
Overfeeding + exercise pre/post training	Experimental	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. Receives: Other: overfeeding + exercise pre-training; Behavioral: fitness training; Other: overfeeding + exercise post-training

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Baseline and 3 months
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)
Measured: Baseline and 3 months

Secondary outcomes (19)

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
Measured: Day 3 and day 4 (baseline stay in respiration chamber)
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
Measured: Day 3 and day 4 (baseline stay in respiration chamber)
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
Measured: Day 3 and day 4 (baseline stay in respiration chamber)
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
Measured: 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
Carbohydrate oxidation measured by indirect calorimetry in respiration chamber on day 4 compared to day 3 after the training period
Measured: 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
Fat balance (calculated as the difference between metabolisable fat intake and fat oxidation) on day 4 compared to day 3 after the training period
Measured: Day 3 and day 4 (stay in respiration chamber at 3 months)
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)
Measured: Baseline and 3 months
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)
Measured: Baseline and 3 months
Change in fat oxidation after training assessed in energy balance
Measured: Baseline and 3 months
Change in carbohydrate oxidation after training assessed in energy balance
Measured: Baseline and 3 months
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.
Measured: 4 days at baseline
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.
Measured: 4 days at 3 months
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)
Measured: Baseline, 2 weeks (pre-training), 3 months (post-training)
adipocyte size
Fat biopsy taken these time points
Measured: Baseline, 2 weeks (pre-training), 3 months (post-training)
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(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
Measured: Baseline, 2 weeks (pre-training), 3 months (post-training)
Change in body composition
Measured using body weight, underwater weighing and deuterium dilution, before and after the fitness training
Measured: Baseline and 3 months
Change in cardiorespiratory fitness
Cardiorespiratory fitness estimated as the maximal oxygen uptake (VO2max) assessed using an incremental test on a bicycle ergometer
Measured: Baseline, after 6-7 weeks of training and 3 months
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)
Measured: Baseline and 3 months
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
Measured: Two 14-day periods (baseline and 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Apr 2015

First posted7 Jan 2015 (estimated)
Study startJun 2014
Primary completionApr 2015

Why it stopped: Recruitment target could not be met

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Overfeeding and ExerciseStudies of the same condition, open and under way.
More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02333916
Sponsor's protocol ID: NL47945.068.14
Acronym: FeedEX
Status last verified: Apr 2015
First submitted: 30 Dec 2014
Last updated: 23 Sep 2015
Results posted: No
Data monitoring committee: Yes

Publications

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. doi: 10.1111/j.1467-789X.2006.00273.x.
PubMed 17300276
Bouchard C, Tremblay A, Despres JP, Nadeau A, Lupien PJ, Theriault 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. doi: 10.1056/NEJM199005243222101.
PubMed 2336074
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. doi: 10.1093/ajcn/56.4.641.
PubMed 1414963
Joosen AM, Bakker AH, Westerterp KR. Metabolic efficiency and energy expenditure during short-term overfeeding. Physiol Behav. 2005 Aug 7;85(5):593-7. doi: 10.1016/j.physbeh.2005.06.006.
PubMed 16039676
Lammert O, Grunnet N, Faber P, Bjornsbo 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.
PubMed 11029975
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. doi: 10.1126/science.283.5399.212.
PubMed 9880251
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. doi: 10.1093/ajcn/33.5.978.
PubMed 7369169
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. doi: 10.1038/sj.ijo.0803146.
PubMed 16247507
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. doi: 10.1093/ajcn/4.2.169. No abstract available.
PubMed 13302165
Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation. 2012 Jul 3;126(1):126-32. doi: 10.1161/CIRCULATIONAHA.111.087213.
PubMed 22753534
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. doi: 10.1093/ajcn/62.1.19.
PubMed 7598063
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. doi: 10.1093/ajcn/64.3.259.
PubMed 8780332
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, Sorensen 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. doi: 10.1210/jc.2005-1598. Epub 2006 Jan 31.
PubMed 16449343
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. doi: 10.1097/00005768-199911001-00025.
PubMed 10593541
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.
PubMed 22556394

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02333916
Acronym / sponsor ID: FeedEX / NL47945.068.14
Conditions: Overfeeding and Exercise
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment target could not be met
Enrolment: 5 participants (actual)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Study start: Jun 2014
Primary completion: Apr 2015 (actual)
First posted: 7 Jan 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Overfeeding + exercise pre/post training	Experimental	Other: overfeeding + exercise pre-training, Behavioral: fitness training, Other: overfeeding + exercise post-trainingoverfeeding + 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.

Who may qualify

Ages: 18 to 30 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Caucasians
Male
Healthy
18-30 years
BMI 21-27.5 kg.m-2

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
overfeeding + exercise pre-training	Other	Overfeeding + exercise pre/post training
fitness training	Behavioural	Overfeeding + exercise pre/post training
overfeeding + exercise post-training	Other	Overfeeding + exercise pre/post training

Primary outcome

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)
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)

19 secondary outcomes

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)
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)
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)
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)
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)
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)
Change in 24-hour carbohydrate oxidation with overfeeding after training
Time frame: Baseline and 3 months
Change in 24-hour carbohydrate oxidation with overfeeding and exercise after training
Time frame: Baseline and 3 months
Change in fat oxidation after training assessed in energy balance
Time frame: Baseline and 3 months
Change in carbohydrate oxidation after training assessed in energy balance
Time frame: Baseline and 3 months
Energy expenditure with overfeeding in inactive men
Time frame: 4 days at baseline
Energy expenditure with overfeeding in active men
Time frame: 4 days at 3 months
Insulin sensitivity
Time frame: Baseline, 2 weeks (pre-training), 3 months (post-training)
adipocyte size
Time frame: 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)
Change in body composition
Time frame: Baseline and 3 months
Change in cardiorespiratory fitness
Time frame: Baseline, after 6-7 weeks of training and 3 months
Change in energy expenditure in free-living conditions
Time frame: Baseline and 3 months
Validity of Actigraph GT3X accelerometer
Time frame: Two 14-day periods (baseline and 3 months)

Results and safety

The study was stopped early (reason given: Recruitment target could not be met). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Background: PubMed 17300276Schokker 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. doi: 10.1111/j.1467-789X.2006.00273.x.
Background: PubMed 2336074Bouchard C, Tremblay A, Despres JP, Nadeau A, Lupien PJ, Theriault 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. doi: 10.1056/NEJM199005243222101.
Background: PubMed 1414963Diaz 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. doi: 10.1093/ajcn/56.4.641.
Background: PubMed 16039676Joosen AM, Bakker AH, Westerterp KR. Metabolic efficiency and energy expenditure during short-term overfeeding. Physiol Behav. 2005 Aug 7;85(5):593-7. doi: 10.1016/j.physbeh.2005.06.006.
Background: PubMed 11029975Lammert O, Grunnet N, Faber P, Bjornsbo 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.
Background: PubMed 9880251Levine 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. doi: 10.1126/science.283.5399.212.
Background: PubMed 7369169Norgan 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. doi: 10.1093/ajcn/33.5.978.
Background: PubMed 16247507Joosen 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. doi: 10.1038/sj.ijo.0803146.
Background: PubMed 13302165MAYER 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. doi: 10.1093/ajcn/4.2.169. No abstract available.
Background: PubMed 22753534Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation. 2012 Jul 3;126(1):126-32. doi: 10.1161/CIRCULATIONAHA.111.087213.
Background: PubMed 7598063Horton 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. doi: 10.1093/ajcn/62.1.19.
Background: PubMed 8780332Jebb 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. doi: 10.1093/ajcn/64.3.259.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wim Saris, MD, PhD principal investigator

Maastricht University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment target could not be met). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour fat balance with overfeeding after training (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02333916, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.