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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
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).
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.
University Hospital Aintree
Liverpool, United Kingdom
Magnitude of weight loss (in kg)
Time frame: 6 months
Resting metabolic rate (RMR)
The measurement of number of calories that the body burns at rest in 24 hours, expressed as kcal/day
Time frame: 6 months
Respiratory Quotient (RQ)
The ratio of carbon dioxide production to oxygen consumption and reflects the relative contribution of fat, carbohydrate, and protein in the oxidation fuel mixture.
Time frame: 6 months
Secretion of gut hormones (GLP-1, GIP, PYY)
Secretion of appetite regulating gut hormone (GLP-1, GIP, PYY) in fasting and post-prandial phase
Time frame: 6 months
Glycaemic variability
Change from baseline in the swings in blood glucose levels, expressed as the mean amplitude of glycaemic excursion (MAGE)
Time frame: 6 months
Insulin sensitivity
Change from baseline in the measure of insulin rise in response to blood sugar levels, expressed as the homeostasis model assessment (HOMA). HOMA estimates steady state beta cell function and insulin sensitivity as percentages of the normal reference population.
Time frame: 6 months
Sensory Neuropathy Testing in Prediabetic Obese Individuals
Change from baseline in vibration perception threshold measurement using the neurothesiometer
Time frame: 6 months
Douleur Neuropathique en4 Questions (DN4)
Change from baseline in Douleur Neuropathique en4 Questions (DN4) using seven interview questions and three physical tests.
Time frame: 6 months
Visual analogue score
Change from baseline in visual analogue score of pain, expressed as Units on a scale of 0 to 100. where 0 is worst possible health and 100 is the best possible health.
Time frame: 6 months
modified Total Neuropathy Score
Change from baseline in modified Total Neuropathy Score (mTNS) questionnaire expressed as the average of the five components
Time frame: 6 months
Brief Pain Inventory Short Form
Change from baseline in brief pain inventory short form (BPI-SF) scored as the mean of the seven interference items.
Time frame: 6 months
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