Clinical trial NCT04597788: Efficacy of Protein Supplemented Very Low Calorie Meals on Weight Loss
Official title: The Role of Protein Supplemented Very Low Calorie Medical Meals on Weight and Metabolic Changes Among People With Obesity: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Sarcopenic Obesity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2020-10-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial will evaluate the efficacy and safety of protein supplemented very low calorie meals on weight loss and weight loss maintenance among people with obesity.

Detailed description: Approximately 30% of the Korean population has obesity or abdominal obesity and is often accompanied by obesity related complications such as cardiovascular disease, diabetes, osteoarthritis and even some types of cancer. However, there are not many lifestyle modification treatments available that have long-term effects other than drugs and surgical treatments in the management of obesity.

Preserving muscle mass should also be considered in weight loss especially for elderly adults with obesity, because decreased muscle mass and strength can negatively affect morbidity and mortality in the elderly.

Therefore, the investigators want to evaluate the effectiveness and safety of the protein supplemented very low calorie meals on weight loss, body composition as well as metabolic changes compared with traditional low calorie low fat diet in people with obesity.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI ) more than 25 kg/m2 or
* Waist circumference more than 90 cm in men or 85 cm in women

Exclusion Criteria:

* History of treatment with anti-obesity drugs or participation in another weight loss program in previous 6 months
* Weight changes more than 3 kg during the 6 months before participation
* Unstable cardiovascular events during the 6 months before participation
* Uncontrolled mood disorder
* History of eating disorder
* History of alcohol use disorder
* History of gallstone
* Chronic renal failure (estimated glomerular filtration less than 30 ml/min)

Primary outcomes:
measure: Changes in weight
timeFrame: 12 months
Secondary outcomes:
measure: Changes in body composition
timeFrame: 12 months
measure: Changes in systolic and diastolic blood pressure
timeFrame: 12 months
measure: Changes in triglyceride
timeFrame: 12 months
measure: Changes in glucose
timeFrame: 12 months
measure: Changes in high density lipoprotein (HDL) Cholesterol
timeFrame: 12 months
measure: Changes in low density lipoprotein (LDL) Cholesterol
timeFrame: 12 months
measure: Changes in liver enzyme
timeFrame: 12 months
measure: Changes in insulin resistance
timeFrame: 12 months
measure: Changes in obesity related quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: