Energy Expenditure From ECAL Indirect Calorimeter in a Multicomponent Weight Management Service

NCT03638895 | Completed DMC

• 1 other identifier: UoL001379
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.

Conditions

Obesity; Severe Obesity; Sleep Apnoea

Keywords

weight management; obesity; severe obesity; structured dietary intervention; calorie restriction; indirect calorimetry; resting energy expenditure; resting metabolic rate; respiratory quotient; substrate oxidation; glycemic variability; insulin sensitivity; peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Magnitude of weight loss (in kg)

  6 months

Secondary Outcomes (10)

• Resting metabolic rate (RMR)

  6 months

• Respiratory Quotient (RQ)

  6 months

• Secretion of gut hormones (GLP-1, GIP, PYY)

  6 months

• Glycaemic variability

  6 months

• Insulin sensitivity

  6 months

Study Arms (2)

ECAL group

ACTIVE COMPARATOR

Intervention group (ECAL) - practitioners and participants receive measured energy information from ECAL indirect calorimeter including resting energy expenditure and respiratory quotient to diagnose, manage and advise on modification of caloric restriction and physical activity level. Energy information also allows participant and practitioner to monitor and compare changes to their metabolic health throughout the duration of intervention.

Device: ECAL Indirect Calorimeter

SC group

PLACEBO COMPARATOR

Standard care (SC) - participants receive standard care (diet, exercise \& behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention.

Behavioral: Diet, exercise & behaviour modification therapy

Interventions

ECAL Indirect Calorimeter DEVICE

The ECAL is an open-circuit portable indirect calorimeter that measures both volume of CO2 expired and O2 consumed using a small mixing chamber. Participants will breathe through a mouthpiece with a nose clip applied whilst lying in a restful and comfortable position for 15 minutes. ECAL device will provide breath-by-breath measurements of the resting energy expenditure and respiratory quotient which will allow both practitioners and participants to monitor their metabolic health and compare the effect of dietary and physical activity intervention over the course of the structured intensive lifestyle intervention (24-weeks).

ECAL group

Diet, exercise & behaviour modification therapy BEHAVIORAL

Standard care (SC) - participants receive standard care (diet, exercise \& behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention.

SC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> or equivalent to 30 kg/m2 to - 60 kg/m2
• Stable weight (change of \<5% within 12 weeks before screening based on medical history)
• Subjects are well-motivated, capable and willing to learn how to undergo indirect calorimetry testing
• Willing and able to adhere to prohibitions and restrictions specified within this protocol
• For Subjects participating in the glycaemic variability sub-study:
• Subject understands instructions on the use of continuous glucose monitor sensor and is willing to undergo appropriate training and testing

You may not qualify if:

• Taking weight loss medication within 12 weeks prior to randomisation
• Previous or planned bariatric surgery
• History of Type 1, Type 2 diabetes mellitus, DKA or diabetes secondary to pancreatitis
• Has HbA1c \> or equal to 6.5% or Fasting Plasma Glucose \> or equal to 7.0 mmol/L at screening.
• NOTE: a one-time repeat measurement is allowed, if value of HbA1c and/or FPG is not consistent with prior values
• History of obesity with a known secondary cause (Cushing's disease/syndrome)
• Oral corticosteroid use (except in the short term use of a 7-10 day course)
• Ongoing, inadequately controlled thyroid disorder defined as thyroid-stimulating hormone \> 6 mIU/litre or \< 0.4 mIU/litre
• History of malignancy within 3 years before screening (or diagnosis of malignancy within this period)
• estimated glomerular filtration rate \< 30 ml/min/1.73m2 on serum testing
• Alanine aminotransferase level is \<2.0 times the upper limit of normal or total bilirubin is \>1.5 times the upper limit of normal at screening
• Other major illness likely to preclude participation in the trial
• History of glucagonoma
• A myocardial infarction, unstable angina, revascularisation procedure (stent or bypass graft surgery) or cerebrovascular accident within 12 weeks before screening

Sponsors & Collaborators

• University of Liverpool: lead
• Metabolic Health Solutions UK: collaborator

Study Sites (1)

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

Location

Related Publications (7)

• Wang X, Wang Y, Ding Z, Cao G, Hu F, Sun Y, Ma Z, Zhou D, Su B. Relative validity of an indirect calorimetry device for measuring resting energy expenditure and respiratory quotient. Asia Pac J Clin Nutr. 2018;27(1):72-77. doi: 10.6133/apjcn.032017.02.

  PMID: 29222882 BACKGROUND

• Das SK, Saltzman E, McCrory MA, Hsu LK, Shikora SA, Dolnikowski G, Kehayias JJ, Roberts SB. Energy expenditure is very high in extremely obese women. J Nutr. 2004 Jun;134(6):1412-6. doi: 10.1093/jn/134.6.1412.

  PMID: 15173405 BACKGROUND

• Melo CM, Tirapegui J, Ribeiro SM. [Human energetic expenditure: concepts, assessment methods and relationship to obesity]. Arq Bras Endocrinol Metabol. 2008 Apr;52(3):452-64. doi: 10.1590/s0004-27302008000300005. Portuguese.

  PMID: 18506270 BACKGROUND

• Lam YY, Ravussin E. Indirect calorimetry: an indispensable tool to understand and predict obesity. Eur J Clin Nutr. 2017 Mar;71(3):318-322. doi: 10.1038/ejcn.2016.220. Epub 2016 Nov 16.

  PMID: 27848941 BACKGROUND

• McLay-Cooke RT, Gray AR, Jones LM, Taylor RW, Skidmore PML, Brown RC. Prediction Equations Overestimate the Energy Requirements More for Obesity-Susceptible Individuals. Nutrients. 2017 Sep 13;9(9):1012. doi: 10.3390/nu9091012.

  PMID: 28902175 BACKGROUND

• Alves VG, da Rocha EE, Gonzalez MC, da Fonseca RB, Silva MH, Chiesa CA. Assessement of resting energy expenditure of obese patients: comparison of indirect calorimetry with formulae. Clin Nutr. 2009 Jun;28(3):299-304. doi: 10.1016/j.clnu.2009.03.011. Epub 2009 Apr 23.

  PMID: 19398250 BACKGROUND

• Lim J, Alam U, Cuthbertson D, Wilding J. Design of a randomised controlled trial: does indirect calorimetry energy information influence weight loss in obesity? BMJ Open. 2021 Mar 24;11(3):e044519. doi: 10.1136/bmjopen-2020-044519.

  PMID: 33762240 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Sleep Apnea Syndromes; Insulin Resistance; Peripheral Nervous System Diseases

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John Wilding, DM FRCP

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double (Participant, Practitioner) Energy expenditure information (resting energy expenditure \& respiratory quotient) is withheld from participant and practitioner providing care to participants in the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine & Honorary Consultant Physician, Obesity and Endocrinology Research, Theme Lead for Metabolism and Nutrition

Model Details: Parallel assignment

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 20, 2018
• Study Start: November 28, 2018
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)