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

U

University of Liverpool

Status

Completed

Conditions

Sleep Apnoea
Obesity
Severe Obesity

Treatments

Behavioral: Diet, exercise & behaviour modification therapy
Device: ECAL Indirect Calorimeter

Study type

Interventional

Funder types

Other

Identifiers

NCT03638895
UoL001379

Details and patient eligibility

About

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.

Full description

Weight loss is important to improve overall health and reduce risk of obesity-related comorbidities such as diabetes. Numerous studies performed on individuals with predisposed genetic propensity to obesity who are deemed to be metabolically 'thrifty', require further structured intensification of caloric restriction and change in physical activity in order to achieve weight loss. Whether greater weight loss is as a result of smaller reduction in energy expenditure with calorie restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. 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 ECAL device also measures the respiratory quotient (RQ) which is the ratio of the volume of carbon dioxide expired to that of oxygen consumed by the individual for every breath. Previous studies demonstrated variability in role of RQ in predicting weight loss, but individuals who demonstrated an RQ in the lower range (<0.72) were more likely to maintain the weight-loss achieved on a caloric restriction and avoid a weight loss rebound as compared to those with RQ in the higher range (>0.75). This suggests that RQ could prove useful in clinical practice as a prognostic marker for long-term effectiveness of low- and very-low-calorie diets used to induce weight loss. Baltimore Longitudinal Study on Aging shared a similar finding that fasting RQ or respiratory exchange ratio adjusted for age, BMI, and fat free mass was positively related to weight change. 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.

Enrollment

51 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

51 participants in 2 patient groups, including a placebo group

ECAL group
Active Comparator group
Description:
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.
Treatment:
Device: ECAL Indirect Calorimeter
SC group
Placebo Comparator group
Description:
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.
Treatment:
Behavioral: Diet, exercise & behaviour modification therapy

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Jonathan ZM Lim, MBChB; John PH Wilding, DM FRCP

Data sourced from clinicaltrials.gov

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