Clinical trial NCT04192357: A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
Official title: A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
name: CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
First posted: 2019-12-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 65 years
* BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2
* Interested in being enrolled in a weight loss program
* Available to comply with study protocol and sign informed consent

Exclusion Criteria:

* Pregnant, breastfeeding or planning to become pregnant within the study period.
* Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)
* Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)
* Subjects with renal impairment
* Subjects with chronic liver disease other than non-alcoholic hepatic steatosis
* Subjects with autoimmune diseases and/or chronic use of corticosteroids.
* Use of weight loss medications/other nutritional supplements
* Subjects with psychiatric or neurological illness
* Subjects sensitive to any component of supplements
* Subjects with surgery or hospitalization in the last 30 days
* Subjects prescribed with 5 or more drugs
* Previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study
* Subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent)
* Subjects with history of drug, alcohol or other substances abuse.
* Eating behavior disorders
* Pacemaker carrier
* Urinary incontinence
* Vegetarians or vegans
* Subjects underwent bariatric surgery
* Type 1 or type 2 diabetes mellitus
* Altered blood clotting
* Severe heart failure

Primary outcomes:
measure: Change in weight
timeFrame: 18 months
Secondary outcomes:
measure: Change in total fat mass
timeFrame: 18 months
measure: Change in waist circumference
timeFrame: 18 months
measure: Change in body mass index
timeFrame: 18 months
measure: Change in systolic and diastolic blood pressure
timeFrame: 18 months
measure: Change in intestinal microbiota
timeFrame: 18 months
measure: Change in fasting plasma glucose concentrations
timeFrame: 18 months
measure: Change in fasting plasma insulin concentrations
timeFrame: 18 months
measure: Change in fasting plasma triglycerides concentrations
timeFrame: 18 months
measure: Change in fasting plasma low density lipoprotein (LDL) concentrations
timeFrame: 18 months
measure: Change in fasting plasma high density lipoprotein (HDL) concentrations
timeFrame: 18 months
measure: Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations
timeFrame: 18 months
measure: Change in alanine aminotransferase (ALT) concentrations
timeFrame: 18 months
measure: Change in aspartate aminotransferase (AST) concentrations
timeFrame: 18 months
measure: Change in gamma-glutamyl transpeptidase (GGT) concentrations
timeFrame: 18 months
measure: Change in HOMA-IR
timeFrame: 18 months
measure: Change in creatinine concentrations
timeFrame: 18 months
measure: Change in vitamin D concentrations
timeFrame: 18 months
measure: Change in high-sensitivity C-reactive protein (hs-CRP) concentrations
timeFrame: 18 months
measure: Change in sodium concentrations
timeFrame: 18 months
measure: Change in potassium concentrations
timeFrame: 18 months
measure: Change in magnesium concentrations
timeFrame: 18 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: NOVA Medical School, NOVA University of Lisbon
Study officials:
affiliation: CINTESIS, NOVA Medical School
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
References: