Lipid MetabolismNCT03029364
Body Composition and Lipid Metabolism at Rest and During Exercise: A Cross-Sectional Analysis.
An observational study of Lipid Metabolism and Substrate Metabolism, run by University of Bath at 1 site in United Kingdom.
Trial summary
The ability to upregulate fat oxidation at appropriate times such as during fasting, low to moderate intensity exercise and after a high fat meal, is popularly advocated. This is presumably due to the perception that a high capacity to utilise fat may improve (ultra) endurance performance and help in the regulation of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism, Substrate Metabolism, Exercise
- What is being tested?
- Study Protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2018to 11 May 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults
Who may be able to join
- be between 18 - 65 years of age
- male or female
- body mass index between 18.9 - 35 kg/m2
- be able and willing to give informed oral and written consent
- complete and meet the defined criteria of pre-study questionnaires and screens
Who cannot join
- Currently have or have a previous history of metabolic, cardio-pulmonary or musculoskeletal disease
- BMI below 18.9 or above 35 kg/m2
- Have plans to change lifestyle (diet and/or physical activity) during the study period ( 7 - 21 days)
- Unwillingness or unable to sufficiently meet study demands
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
The ability to upregulate fat oxidation at appropriate times such as during fasting, low to moderate intensity exercise and after a high fat meal, is popularly advocated. This is presumably due to the perception that a high capacity to utilise fat may improve (ultra) endurance performance and help in the regulation of body fat and metabolic diseases. In accordance, impaired fat use at rest has been associated with obesity and insulin resistance (Kelley et al., 1999). However, there is inconclusive and / or a lack of systematic evidence, especially in a large diverse range of adults, exploring:
- Whether whole body fat use during exercise is altered in individuals with overweight or obesity compared to lean individuals
- The intra-individual variability in whole-body fat use at rest and during exercise
- Physiological, metabolic, lifestyle and genetic characteristics that are associated with whole-body fat use at rest and during exercise
Read more
Therefore, the objectives of this study are three-fold:
- To explore whether whole body fat use is associated with body composition
- To explore associations between whole-body fat use and physiological, metabolic, lifestyle and genetic variables
- To assess the intra-individual variability of whole-body fat use.
This study is an observational, exploratory cross-sectional study. A wide range of 'healthy' and 'at-risk of metabolic disease' adults will be recruited.
Participants will be asked to visit a laboratory at the University of Bath four times. Visit 1 is a screening and study familiarisation visit. Visits 2 and 3 are to be completed within 7-14 days and involve lifestyle monitoring (dietary and physical activity), a one-off urine and blood sample, assessment of fuel use at rest and during exercise (the latter through an incremental graded cycling exercise test to exhaustion). Visit 4 is to assess body composition via a dual-energy x-ray absorptiometry (DEXA) scan in addition to an optional skeletal muscle and / or fat tissue biopsy.
Read the detailed description
Metabolic flexibility broadly refers to the ability to utilize the right fuel source for energy (primarily either carbohydrate or fat) at the right time (Kelley and Mandarino, 2000). This was first conceptualised at the level of skeletal muscle (Kelley and Mandarino, 1990; Andres et al., 1956). A main tenant originally captured by 'metabolic flexibility' is the predominant utilization of fat as an energy source under rested post-absorptive conditions in 'healthy' individuals (Kelley et al., 1999; Kelley and Mandarino, 1990). Recently, there has been a call to extend the concept of 'metabolic flexibility' to exercising conditions (Goodpaster and Sparks, 2017; Rynders et al., 2017). Similarly to at rest, fat provides an important source of energy during low-to-moderate intensity exercise (van Loon et al., 2001; Romijn et al., 1993). Thus, in healthy individuals at the whole-body and skeletal muscle level, it is robustly characterised and accepted that fat is an important and predominant fuel source for energy under such conditions.
However, it is commonly proposed that a lower reliance upon fat as a fuel source is present in individuals with obesity and type 2 diabetes and consequently, has been implicated in the pathogenesis of such conditions (Rynders et al., 2017; Kelley and Mandarino, 2000). Alternatively, a high capacity to utilize fat under the aforementioned two situations is advocated to be a desirable trait for both athletes and non-athletes, presumably due to the perception that high rates of fat utilization may improve endurance performance and/or assist with the regulation of body fat and metabolic health. As such, much interest has been generated into upregulating fat utilization at appropriate times e.g. during fasting and low-to-moderate intensity exercise.
Correspondingly, lower resting and exercising fat use has been reported in individuals with obesity vs lean (e.g. Lanzi et al., 2014; Perez-Martin et al., 2001; Kelley et al., 1999). Furthermore, greater fat use at rest has been associated with lower future body weight and fat gain / regain (e.g. Shook et al., 2016; Seidell et al., 1992), and during exercise with reduced short term post-exercise energy intake / balance (e.g. Hopkins et al., 2012), exercise-induced fat loss (Barwell et al., 2008) and weight loss / maintenance (Dandadell et al., 2017). Importantly, however, this relationship is not always apparent with similar (e.g. Blaize et a., 2014; Croci et al., 2014) or higher (e.g. Ara et al., 2011; Goodpaster et al., 2002; Horowtiz et al., 2000) rates of fat use at rest and during exercise reported in individuals with obesity compared to lean counterparts. Furthermore, cross-sectional and prospective associations do not always exist between lower fat use and greater body weight / fat mass gain or regain (e.g. Dandanell et al., 2017; Ellis et al., 2010). Thus, despite being popularly advocated, it is currently unclear whether lower fat use at rest or during exercise predisposes or is a characteristic of excess adiposity (i.e. obesity).
The inconsistent findings could partly be due to numerous methodological discrepancies between studies such as participant characteristics, matching of comparative groups, the exercise protocol utilised and / or the assessment of body composition, lipid oxidation and cardio-respiratory fitness levels.
Therefore, through the use of well-established and respected techniques, we aim to comprehensively and systematically explore whether whole-body fat use at rest and during exercise is:
- Altered in individuals with overweight or obesity compared to lean individuals
- Further determinants / factors that may influence fat use
- The intra-individual variation in fat use which will help to more confidently determine the above objectives.
- Conditions
- Lipid Metabolism, Substrate Metabolism, Exercise
- Being tested
- Study Protocol
- Keywords
- Maximal Fat Oxidation, Exercise, Intra-individual variability, Determinants, Whole-body fat oxidation, Body composition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study ProtocolBehavioural
Participants will complete three study protocols 7 - 28 days apart which includes:
- 3 x main trial days (max. 150 mins) involving body composition analysis, indirect calorimetry, a blood sample, optional muscle and / or adipose tissue biopsies and a maximal cardiorespiratory fitness test.
- 2 x lifestyle monitoring periods (physical activity and diet) for the prior 7 days before each main trial day.
- Maintenance of habitual habits, dietary and physical activity behaviour patterns
We are observing biological / health parameters in a group of individuals who will be assessed under resting and exercising conditions. The current study does not involve an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Male and Female Adults | Completion of Study Protocol Receives: Behavioral: Study Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal rate of whole-body fat oxidation (mg/kg FFM/min)
Fat free mass (FFM). Assessed during the incremental stage maximal cardio-respiratory fitness test
Measured: 7 - 14 days
Secondary outcomes (37)
Maximal rate of whole-body fat oxidation (g/min)
Non-adjusted rate. Assessed during the incremental stage maximal cardio-respiratory fitness test
Measured: 7-14 days
FATmax (% of maximum oxygen consumption)
The exercise intensity that maximal rate of whole-body fat oxidation occurs at. Expressed as % of VO2peak). Assessed during the incremental stage maximal cardio-respiratory fitness test.
Measured: 7 - 14 days
FATmax (% of Watt max)
The exercise intensity that maximal rate of whole-body fat oxidation occurs at. Expressed as % of Watt max). Assessed during the incremental stage maximal cardio-respiratory fitness test.
Measured: 7 - 14 days
FATmax (% of Heart Rate max)
The exercise intensity that maximal rate of whole-body fat oxidation occurs at. expressed either as % of heart rate max). Assessed during the incremental stage maximal cardio-respiratory fitness test
Measured: 7 - 14 days
Whole-body substrate oxidation rates (Carbohydrates and Lipid) during exercise
Assessed during the incremental stage maximal cardio-respiratory fitness test via indirect calorimetry of expired gas samples.
Measured: 7 - 14 days
Whole-body substrate oxidation rates (Carbohydrates and Lipid) at rest
Assessed at rest through the participant lying in a semi-supine position via indirect calorimetry of expired gas samples.
Measured: 7 - 14 days
Resting metabolic rate
Assessed at rest through the participant lying in a semi-supine position via indirect calorimetry of expired gas samples.
Measured: 7 - 14 days
Cardiorespiratory fitness (VO2peak)
Assessed during the incremental stage maximal cardio-respiratory fitness test
Measured: 7 - 14 days
Habitual Energy Intake
Participants will be asked to complete a self-weighed food and drink diary before each main trial day (Visit 2 and 3) so that average daily calorie and macronutrient intake can be calculated. The procedure will be explained by the CI. This diet monitoring period must include 3 week-days, at least one 1 weekend day and the immediate 48-hrs prior to the beginning of each main trial (Visit 2 and 3). Additionally, the prior 48-hrs before Visit 2 will be replicated before Visit 3.
Measured: 7 - 21 days
Habitual Energy Expenditure / Physical Activity
Physical activity will be measured by accelerometry and heart-rate monitoring for 7 days before each main trial day (Visit 2 and 3). This procedure will be explained by the CI. ntake can be calculated. The participants physical activity levels for the immediate 48-hrs prior to the beginning of each main trial (Visit 2 and 3) will be asked to be replicated as closely as possible.
Measured: 7 - 21 days
Menstrual Cycle (females only)
Assessed through a self-reported menstrual cycle questionnaire
Measured: 7 - 21 days
Self-reported Physical Activity level
Assessed by the International Physical Activity Questionnaire (long form)
Measured: 7-21 days
Fasting glucose concentration
Assessed via plasma sample extracted from the blood sample
Measured: 7-21 days
Fasting lipid profiles (triglycerides / cholesterol)
Assessed via serum sample extracted from the blood sample
Measured: 7-21 days
Fasting Adipose tissue derived hormone concentrations (leptin, adiponectin)
Assessed via plasma sample extracted from the blood sample
Measured: 7-21 days
Fasting catecholamine concentrations (epinephrine and norepinephrine)
Assessed via plasma sample extracted from the blood sample
Measured: 7-21 days
Fasting sex hormone concentrations (17 beta-estradiol, testosterone, progesterone)
Assessed via serum sample extracted from the blood sample
Measured: 7-21 days
Fasting pancreatic derived hormone concentrations (insulin and glucagon)
Assessed via plasma sample extracted from the blood sample
Measured: 7-21 days
Hydration Status (urine specific gravity)
Assessed via analysis of urine sample with a refractometer
Measured: 7-21 days
Age
Assessed via a participant questionnaire
Measured: 7-21 days
Sex
Assessed via a participant questionnaire
Measured: 7-21 days
Ethnicity
Assessed via a participant questionnaire
Measured: 7-21 days
Smoking Status
Assessed via a participant questionnaire
Measured: 7-21 days
Medication / supplement use
Assessed via a participant questionnaire
Measured: 7-21 days
Dietary pattern / requirements (e.g. vegetarian, vegan, Celiac disease)
Assessed via a participant questionnaire
Measured: 7-21 days
Body Mass (kg)
Assessed via body weighing scales
Measured: 7-21 days
Body Mass Index (kg/m2)
Assessed by dividing body weight in kg by height in metres squared.
Measured: 7-21 days
Waist circumference (cm)
Assessed via use of an anthropometric tape measure
Measured: 7-21 days
Hip Circumference (cm)
Assessed via use of an anthropometric tape measure
Measured: 7-21 days
Body fat percentage
Assessed via a dual energy xray absorptiometry scan at Visit 4.
Measured: 1 day
Body fat localisation
Assessed via a dual energy xray absorptiometry scan at Visit 4.
Measured: 1 day
Lean body mass
Assessed via a dual energy xray absorptiometry scan at Visit 4.
Measured: 1 day
Body fat percentage
Bioelectrical Impedance Analysis from the body weighing scales
Measured: 7-21 days
Genotyping analysis
Genotyping analysis will be assessed through the extraction of the buffy coat layer from the blood sample
Measured: 7 - 21 days
Skeletal Muscle sample (Optional)
The optional muscle sample will be obtained from the quadriceps muscle using the Bergstrom technique on Visit 4.
Measured: 1 day
Adipose Tissue (Fat) sample (Optional)
The optional fat sample will be obtained from the subcutaneous abdominal region (5 cm laterally of the umbilicus) via the 'lipoaspiration' technique on Visit 4.
Measured: 1 day
Fat mass index (body fat in kg/m2)
Assessed by dividing body fat in kg by height in metres squared.
Measured: 7 - 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start8 Jan 2018
- Primary completion28 May 2019
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Lipid MetabolismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
- Investigators
- Javier T Gonzalez, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029364
- Sponsor's protocol ID
- 17/SW/0269
- Status last verified
- May 2024
- First submitted
- 14 Jan 2017
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kelley DE, Mandarino LJ. Fuel selection in human skeletal muscle in insulin resistance: a reexamination. Diabetes. 2000 May;49(5):677-83. doi: 10.2337/diabetes.49.5.677.
PubMed 10905472Kelley DE, Mandarino LJ. Hyperglycemia normalizes insulin-stimulated skeletal muscle glucose oxidation and storage in noninsulin-dependent diabetes mellitus. J Clin Invest. 1990 Dec;86(6):1999-2007. doi: 10.1172/JCI114935.
PubMed 2123890ANDRES R, CADER G, ZIERLER KL. The quantitatively minor role of carbohydrate in oxidative metabolism by skeletal muscle in intact man in the basal state; measurements of oxygen and glucose uptake and carbon dioxide and lactate production in the forearm. J Clin Invest. 1956 Jun;35(6):671-82. doi: 10.1172/JCI103324. No abstract available.
PubMed 13319506Goodpaster BH, Sparks LM. Metabolic Flexibility in Health and Disease. Cell Metab. 2017 May 2;25(5):1027-1036. doi: 10.1016/j.cmet.2017.04.015.
PubMed 28467922Rynders CA, Blanc S, DeJong N, Bessesen DH, Bergouignan A. Sedentary behaviour is a key determinant of metabolic inflexibility. J Physiol. 2018 Apr 15;596(8):1319-1330. doi: 10.1113/JP273282. Epub 2017 Jul 4.
PubMed 28543022van Loon LJ, Greenhaff PL, Constantin-Teodosiu D, Saris WH, Wagenmakers AJ. The effects of increasing exercise intensity on muscle fuel utilisation in humans. J Physiol. 2001 Oct 1;536(Pt 1):295-304. doi: 10.1111/j.1469-7793.2001.00295.x.
PubMed 11579177Romijn JA, Coyle EF, Sidossis LS, Gastaldelli A, Horowitz JF, Endert E, Wolfe RR. Regulation of endogenous fat and carbohydrate metabolism in relation to exercise intensity and duration. Am J Physiol. 1993 Sep;265(3 Pt 1):E380-91. doi: 10.1152/ajpendo.1993.265.3.E380.
PubMed 8214047Lanzi S, Codecasa F, Cornacchia M, Maestrini S, Salvadori A, Brunani A, Malatesta D. Fat oxidation, hormonal and plasma metabolite kinetics during a submaximal incremental test in lean and obese adults. PLoS One. 2014 Feb 11;9(2):e88707. doi: 10.1371/journal.pone.0088707. eCollection 2014.
PubMed 24523934Perez-Martin A, Dumortier M, Raynaud E, Brun JF, Fedou C, Bringer J, Mercier J. Balance of substrate oxidation during submaximal exercise in lean and obese people. Diabetes Metab. 2001 Sep;27(4 Pt 1):466-74.
PubMed 11547220Kelley DE, Goodpaster B, Wing RR, Simoneau JA. Skeletal muscle fatty acid metabolism in association with insulin resistance, obesity, and weight loss. Am J Physiol. 1999 Dec;277(6):E1130-41. doi: 10.1152/ajpendo.1999.277.6.E1130.
PubMed 10600804Shook RP, Hand GA, Paluch AE, Wang X, Moran R, Hebert JR, Jakicic JM, Blair SN. High respiratory quotient is associated with increases in body weight and fat mass in young adults. Eur J Clin Nutr. 2016 Oct;70(10):1197-1202. doi: 10.1038/ejcn.2015.198. Epub 2015 Nov 25.
PubMed 26603877Seidell JC, Muller DC, Sorkin JD, Andres R. Fasting respiratory exchange ratio and resting metabolic rate as predictors of weight gain: the Baltimore Longitudinal Study on Aging. Int J Obes Relat Metab Disord. 1992 Sep;16(9):667-74.
PubMed 1328091Hopkins M, Blundell JE, King NA. Individual variability in compensatory eating following acute exercise in overweight and obese women. Br J Sports Med. 2014 Oct;48(20):1472-6. doi: 10.1136/bjsports-2012-091721. Epub 2013 May 10.
PubMed 23666018Barwell ND, Malkova D, Leggate M, Gill JM. Individual responsiveness to exercise-induced fat loss is associated with change in resting substrate utilization. Metabolism. 2009 Sep;58(9):1320-8. doi: 10.1016/j.metabol.2009.04.016. Epub 2009 Jun 18.
PubMed 19501861Dandanell S, Husted K, Amdisen S, Vigelso A, Dela F, Larsen S, Helge JW. Influence of maximal fat oxidation on long-term weight loss maintenance in humans. J Appl Physiol (1985). 2017 Jul 1;123(1):267-274. doi: 10.1152/japplphysiol.00270.2017. Epub 2017 May 25.
PubMed 28546468
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and Lipid Metabolism at Rest and During Exercise: A Cross-Sectional Analysis.
- ClinicalTrials.gov ID
- NCT03029364
- Acronym / sponsor ID
- 17/SW/0269
- Conditions
- Lipid Metabolism, Substrate Metabolism, Exercise
- Keywords
- Maximal Fat Oxidation, Exercise, Intra-individual variability, Determinants, Whole-body fat oxidation, Body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 24 Jan 2017 (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.
The ability to upregulate fat oxidation at appropriate times such as during fasting, low to moderate intensity exercise and after a high fat meal, is popularly advocated. This is presumably due to the perception that a high capacity to utilise fat may improve (ultra) endurance performance and help in the regulation of body fat and metabolic diseases. In accordance, impaired fat use at rest has been associated with obesity and insulin resistance (Kelley et al., 1999). However, there is inconclusive and / or a lack of systematic evidence, especially in a large diverse range of adults, exploring:
- Whether whole body fat use during exercise is altered in individuals with overweight or obesity compared to lean individuals
- The intra-individual variability in whole-body fat use at rest and during exercise
- Physiological, metabolic, lifestyle and genetic characteristics that are associated with whole-body fat use at rest and during exercise
Therefore, the objectives of this study are three-fold:
- To explore whether whole body fat use is associated with body composition
- To explore associations between whole-body fat use and physiological, metabolic, lifestyle and genetic variables
- To assess the intra-individual variability of whole-body fat use.
This study is an observational, exploratory cross-sectional study. A wide range of 'healthy' and 'at-risk of metabolic disease' adults will be recruited.
Participants will be asked to visit a laboratory at the University of Bath four times. Visit 1 is a screening and study familiarisation visit. Visits 2 and 3 are to be completed within 7-14 days and involve lifestyle monitoring (dietary and physical activity), a one-off urine and blood sample, assessment of fuel use at rest and during exercise (the latter through an incremental graded cycling exercise test to exhaustion). Visit 4 is to assess body composition via a dual-energy x-ray absorptiometry (DEXA) scan in addition to an optional skeletal muscle and / or fat tissue biopsy.
Detailed description
Metabolic flexibility broadly refers to the ability to utilize the right fuel source for energy (primarily either carbohydrate or fat) at the right time (Kelley and Mandarino, 2000). This was first conceptualised at the level of skeletal muscle (Kelley and Mandarino, 1990; Andres et al., 1956). A main tenant originally captured by 'metabolic flexibility' is the predominant utilization of fat as an energy source under rested post-absorptive conditions in 'healthy' individuals (Kelley et al., 1999; Kelley and Mandarino, 1990). Recently, there has been a call to extend the concept of 'metabolic flexibility' to exercising conditions (Goodpaster and Sparks, 2017; Rynders et al., 2017). Similarly to at rest, fat provides an important source of energy during low-to-moderate intensity exercise (van Loon et al., 2001; Romijn et al., 1993). Thus, in healthy individuals at the whole-body and skeletal muscle level, it is robustly characterised and accepted that fat is an important and predominant fuel source for energy under such conditions.
However, it is commonly proposed that a lower reliance upon fat as a fuel source is present in individuals with obesity and type 2 diabetes and consequently, has been implicated in the pathogenesis of such conditions (Rynders et al., 2017; Kelley and Mandarino, 2000). Alternatively, a high capacity to utilize fat under the aforementioned two situations is advocated to be a desirable trait for both athletes and non-athletes, presumably due to the perception that high rates of fat utilization may improve endurance performance and/or assist with the regulation of body fat and metabolic health. As such, much interest has been generated into upregulating fat utilization at appropriate times e.g. during fasting and low-to-moderate intensity exercise.
Correspondingly, lower resting and exercising fat use has been reported in individuals with obesity vs lean (e.g. Lanzi et al., 2014; Perez-Martin et al., 2001; Kelley et al., 1999). Furthermore, greater fat use at rest has been associated with lower future body weight and fat gain / regain (e.g. Shook et al., 2016; Seidell et al., 1992), and during exercise with reduced short term post-exercise energy intake / balance (e.g. Hopkins et al., 2012), exercise-induced fat loss (Barwell et al., 2008) and weight loss / maintenance (Dandadell et al., 2017). Importantly, however, this relationship is not always apparent with similar (e.g. Blaize et a., 2014; Croci et al., 2014) or higher (e.g. Ara et al., 2011; Goodpaster et al., 2002; Horowtiz et al., 2000) rates of fat use at rest and during exercise reported in individuals with obesity compared to lean counterparts. Furthermore, cross-sectional and prospective associations do not always exist between lower fat use and greater body weight / fat mass gain or regain (e.g. Dandanell et al., 2017; Ellis et al., 2010). Thus, despite being popularly advocated, it is currently unclear whether lower fat use at rest or during exercise predisposes or is a characteristic of excess adiposity (i.e. obesity).
The inconsistent findings could partly be due to numerous methodological discrepancies between studies such as participant characteristics, matching of comparative groups, the exercise protocol utilised and / or the assessment of body composition, lipid oxidation and cardio-respiratory fitness levels.
Therefore, through the use of well-established and respected techniques, we aim to comprehensively and systematically explore whether whole-body fat use at rest and during exercise is:
- Altered in individuals with overweight or obesity compared to lean individuals
- Further determinants / factors that may influence fat use
- The intra-individual variation in fat use which will help to more confidently determine the above objectives.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male and Female Adults | – | Behavioral: Study ProtocolCompletion of Study Protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults
Key inclusion criteria (5 listed)
- be between 18 - 65 years of age
- male or female
- body mass index between 18.9 - 35 kg/m2
- be able and willing to give informed oral and written consent
- complete and meet the defined criteria of pre-study questionnaires and screens
Key exclusion criteria (4 listed)
- Currently have or have a previous history of metabolic, cardio-pulmonary or musculoskeletal disease
- BMI below 18.9 or above 35 kg/m2
- Have plans to change lifestyle (diet and/or physical activity) during the study period ( 7 - 21 days)
- Unwillingness or unable to sufficiently meet study demands
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 |
|---|---|---|
| Study ProtocolParticipants will complete three study protocols 7 - 28 days apart which includes: * 3 x main trial days (max. 150 mins) involving body composition analysis, indirect calorimetry, a blood sample, optional muscle and / or adipose tissue biopsies and a maximal cardiorespiratory fitness test. * 2 x lifestyle monitoring periods (physical activity and diet) for the prior 7 days before each main trial day. * Maintenance of habitual habits, dietary and physical activity behaviour patterns We are observing biological / health parameters in a group of individuals who will be assessed under resting and exercising conditions. The current study does not involve an intervention. | Behavioural | Male and Female Adults |
Primary outcome
Maximal rate of whole-body fat oxidation (mg/kg FFM/min)
Time frame: 7 - 14 days
Fat free mass (FFM). Assessed during the incremental stage maximal cardio-respiratory fitness test
37 secondary outcomes
Maximal rate of whole-body fat oxidation (g/min)
Time frame: 7-14 days
FATmax (% of maximum oxygen consumption)
Time frame: 7 - 14 days
FATmax (% of Watt max)
Time frame: 7 - 14 days
FATmax (% of Heart Rate max)
Time frame: 7 - 14 days
Whole-body substrate oxidation rates (Carbohydrates and Lipid) during exercise
Time frame: 7 - 14 days
Whole-body substrate oxidation rates (Carbohydrates and Lipid) at rest
Time frame: 7 - 14 days
Resting metabolic rate
Time frame: 7 - 14 days
Cardiorespiratory fitness (VO2peak)
Time frame: 7 - 14 days
Habitual Energy Intake
Time frame: 7 - 21 days
Habitual Energy Expenditure / Physical Activity
Time frame: 7 - 21 days
Menstrual Cycle (females only)
Time frame: 7 - 21 days
Self-reported Physical Activity level
Time frame: 7-21 days
Fasting glucose concentration
Time frame: 7-21 days
Fasting lipid profiles (triglycerides / cholesterol)
Time frame: 7-21 days
Fasting Adipose tissue derived hormone concentrations (leptin, adiponectin)
Time frame: 7-21 days
Fasting catecholamine concentrations (epinephrine and norepinephrine)
Time frame: 7-21 days
Fasting sex hormone concentrations (17 beta-estradiol, testosterone, progesterone)
Time frame: 7-21 days
Fasting pancreatic derived hormone concentrations (insulin and glucagon)
Time frame: 7-21 days
Hydration Status (urine specific gravity)
Time frame: 7-21 days
Age
Time frame: 7-21 days
Sex
Time frame: 7-21 days
Ethnicity
Time frame: 7-21 days
Smoking Status
Time frame: 7-21 days
Medication / supplement use
Time frame: 7-21 days
Dietary pattern / requirements (e.g. vegetarian, vegan, Celiac disease)
Time frame: 7-21 days
Body Mass (kg)
Time frame: 7-21 days
Body Mass Index (kg/m2)
Time frame: 7-21 days
Waist circumference (cm)
Time frame: 7-21 days
Hip Circumference (cm)
Time frame: 7-21 days
Body fat percentage
Time frame: 1 day
Body fat localisation
Time frame: 1 day
Lean body mass
Time frame: 1 day
Body fat percentage
Time frame: 7-21 days
Genotyping analysis
Time frame: 7 - 21 days
Skeletal Muscle sample (Optional)
Time frame: 1 day
Adipose Tissue (Fat) sample (Optional)
Time frame: 1 day
Fat mass index (body fat in kg/m2)
Time frame: 7 - 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 10905472Kelley DE, Mandarino LJ. Fuel selection in human skeletal muscle in insulin resistance: a reexamination. Diabetes. 2000 May;49(5):677-83. doi: 10.2337/diabetes.49.5.677.
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- Individual participant dataSharing planned: Undecided
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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.
Javier T Gonzalez, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Metabolism and Substrate Metabolism, run by University of Bath at 1 site in United Kingdom.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 May 2024. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximal rate of whole-body fat oxidation (mg/kg FFM/min) (time frame: 7 - 14 days). 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 NCT03029364, which also lists 21 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 14 May 2024.