Obesity
Conditions
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.
Interventions
BEHAVIORALWLM3P
18 months behavioral weight loss program divided into three phases (first and second phase of weight loss, during 1 month and 5 months, respectively; and a third phase of weight maintenance, during 12 months).
BEHAVIORALLow-carb diet
18 months behavioral weight loss program divided in two phases (first of weight loss during 6 months and a second phase of weight maintenance during 12 months).
Sponsors
NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | 18 months | Difference between the intervention and control group in the change of weight from baseline to the end of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in waist circumference | 18 months | Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up. |
| Change in body mass index | 18 months | Change in body mass index (calculated as change in kg/m2, weight in kilograms, height in meters) from baseline to the end of follow-up. |
| Change in systolic and diastolic blood pressure | 18 months | Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up. |
| Change in intestinal microbiota | 18 months | Difference between the intervention and control group in the change of intestinal microbiota from baseline to the end of follow-up. Bacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage. |
| Change in fasting plasma glucose concentrations | 18 months | Difference between the intervention and control group in the change of serum glucose concentrations from baseline to the end of follow-up. |
| Change in fasting plasma insulin concentrations | 18 months | Difference between the intervention and control group in the change of serum insulin concentrations from baseline to the end of follow-up. |
| Change in fasting plasma triglycerides concentrations | 18 months | Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up. |
| Change in fasting plasma low density lipoprotein (LDL) concentrations | 18 months | Difference between the intervention and control group in the change of serum low density lipoprotein (LDL) concentrations from baseline to the end of follow-up. |
| Change in fasting plasma high density lipoprotein (HDL) concentrations | 18 months | Difference between the intervention and control group in the change of serum high density lipoprotein (HDL) concentrations from baseline to the end of follow-up. |
| Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations | 18 months | Difference between the intervention and control group in the change of serum glycated hemoglobin A1c (HbA1c) concentrations from baseline to the end of follow-up. |
| Change in total fat mass | 18 months | Difference between the intervention and control group in the change of total fat mass, measured by bioimpedance analysis from baseline to the end of follow-up. |
| Change in aspartate aminotransferase (AST) concentrations | 18 months | Difference between the intervention and control group in the change of aspartate aminotransferase (AST) concentrations from baseline to the end of follow-up. |
| Change in gamma-glutamyl transpeptidase (GGT) concentrations | 18 months | Difference between the intervention and control group in the change of gamma-glutamyl transpeptidase (GGT) concentrations from baseline to the end of follow-up. |
| Change in HOMA-IR | 18 months | Difference between the intervention and control group in HOMA-IR (homeostasis model assessment of insulin resistance) from baseline to the end of follow-up, calculated using the formula: fasting plasma glucose (mmol/L) x Fasting insulin (mIU/L)/22.5. |
| Change in creatinine concentrations | 18 months | Difference between the intervention and control group in the change of creatinine concentrations from baseline to the end of follow-up. |
| Change in vitamin D concentrations | 18 months | Difference between the intervention and control group in the change of vitamin D concentrations from baseline to the end of follow-up. |
| Change in high-sensitivity C-reactive protein (hs-CRP) concentrations | 18 months | Difference between the intervention and control group in the change of high-sensitivity C-reactive protein (hs-CRP) concentrations from baseline to the end of follow-up. |
| Change in sodium concentrations | 18 months | Difference between the intervention and control group in the change of sodium concentrations from baseline to the end of follow-up. |
| Change in potassium concentrations | 18 months | Difference between the intervention and control group in the change of potassium concentrations from baseline to the end of follow-up. |
| Change in magnesium concentrations | 18 months | Difference between the intervention and control group in the change of magnesium concentrations from baseline to the end of follow-up. |
| Change in alanine aminotransferase (ALT) concentrations | 18 months | Difference between the intervention and control group in the change of alanine aminotransferase (ALT) concentrations from baseline to the end of follow-up. |
Countries
Portugal
Outcome results
None listed