NCT03029364

Brief 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 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: 1\) Whether whole body fat use during exercise is altered in individuals with overweight or obesity compared to lean individuals 3\) The intra-individual variability in whole-body fat use at rest and during exercise 4\) 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:

  1. 1.To explore whether whole body fat use is associated with body composition
  2. 2.To explore associations between whole-body fat use and physiological, metabolic, lifestyle and genetic variables
  3. 3.To assess the intra-individual variability of whole-body fat use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

January 14, 2017

Last Update Submit

May 11, 2024

Conditions

Keywords

Maximal Fat OxidationExerciseIntra-individual variabilityDeterminantsWhole-body fat oxidationBody composition

Outcome Measures

Primary Outcomes (1)

  • 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

    7 - 14 days

Secondary Outcomes (37)

  • Maximal rate of whole-body fat oxidation (g/min)

    7-14 days

  • FATmax (% of maximum oxygen consumption)

    7 - 14 days

  • FATmax (% of Watt max)

    7 - 14 days

  • FATmax (% of Heart Rate max)

    7 - 14 days

  • Whole-body substrate oxidation rates (Carbohydrates and Lipid) during exercise

    7 - 14 days

  • +32 more secondary outcomes

Study Arms (1)

Male and Female Adults

Completion of Study Protocol

Behavioral: Study Protocol

Interventions

Study ProtocolBEHAVIORAL

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.

Male and Female Adults

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

Related Publications (21)

  • 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.

    PMID: 10905472BACKGROUND
  • Kelley 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.

    PMID: 2123890BACKGROUND
  • ANDRES 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.

    PMID: 13319506BACKGROUND
  • Goodpaster 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.

    PMID: 28467922BACKGROUND
  • Rynders 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.

    PMID: 28543022BACKGROUND
  • van 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.

    PMID: 11579177BACKGROUND
  • Romijn 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.

    PMID: 8214047BACKGROUND
  • Lanzi 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.

    PMID: 24523934BACKGROUND
  • Perez-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.

    PMID: 11547220BACKGROUND
  • Kelley 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.

    PMID: 10600804BACKGROUND
  • Shook 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.

    PMID: 26603877BACKGROUND
  • Seidell 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.

    PMID: 1328091BACKGROUND
  • Hopkins 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.

    PMID: 23666018BACKGROUND
  • Barwell 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.

    PMID: 19501861BACKGROUND
  • Dandanell 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.

    PMID: 28546468BACKGROUND
  • Blaize AN, Potteiger JA, Claytor RP, Noe DA. Body fat has no effect on the maximal fat oxidation rate in young, normal, and overweight women. J Strength Cond Res. 2014 Aug;28(8):2121-6. doi: 10.1519/JSC.0000000000000512.

    PMID: 24796985BACKGROUND
  • Croci I, Hickman IJ, Wood RE, Borrani F, Macdonald GA, Byrne NM. Fat oxidation over a range of exercise intensities: fitness versus fatness. Appl Physiol Nutr Metab. 2014 Dec;39(12):1352-9. doi: 10.1139/apnm-2014-0144. Epub 2014 Aug 1.

    PMID: 25356842BACKGROUND
  • Ara I, Larsen S, Stallknecht B, Guerra B, Morales-Alamo D, Andersen JL, Ponce-Gonzalez JG, Guadalupe-Grau A, Galbo H, Calbet JA, Helge JW. Normal mitochondrial function and increased fat oxidation capacity in leg and arm muscles in obese humans. Int J Obes (Lond). 2011 Jan;35(1):99-108. doi: 10.1038/ijo.2010.123. Epub 2010 Jun 15.

    PMID: 20548301BACKGROUND
  • Horowitz JF, Klein S. Oxidation of nonplasma fatty acids during exercise is increased in women with abdominal obesity. J Appl Physiol (1985). 2000 Dec;89(6):2276-82. doi: 10.1152/jappl.2000.89.6.2276.

    PMID: 11090579BACKGROUND
  • Goodpaster BH, Wolfe RR, Kelley DE. Effects of obesity on substrate utilization during exercise. Obes Res. 2002 Jul;10(7):575-84. doi: 10.1038/oby.2002.78.

    PMID: 12105277BACKGROUND
  • Ellis AC, Hyatt TC, Hunter GR, Gower BA. Respiratory quotient predicts fat mass gain in premenopausal women. Obesity (Silver Spring). 2010 Dec;18(12):2255-9. doi: 10.1038/oby.2010.96. Epub 2010 May 6.

    PMID: 20448540BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and buffy coat layer extraction from blood samples. Skeletal muscle and adipose tissue (fat) samples. Urine sample for immediate analysis and disposal.

MeSH Terms

Conditions

Motor Activity

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Javier T Gonzalez, PhD

    University of Bath

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (Assistant Professor) in Human Physiology

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 24, 2017

Study Start

January 8, 2018

Primary Completion

May 28, 2019

Study Completion

May 11, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations