Overweight/obese adult subjects Nutritional, Metabolic, Endocrine
Conditions
Interventions
Obesity is a complex and multifactorial disease that currently affects more than one-third of the world's population, representing a key risk factor for numerous diseases, such as cardiovascular disea
Sponsors
University of Naples Federico II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18–70 years 2. Overweight/Obese subjects (Body Mass Index 25-45 kg/m²)
Exclusion criteria
Exclusion criteria: 1. Participation in other clinical studies 2. Weight change greater than 3 kg in the last 2 months 3. Cancer or diagnosis of cancer in the last 5 years 4. Acute or chronic inflammatory and metabolic diseases (e.g. Crohn's disease, rheumatoid arthritis, etc.) 5. Patients with type 1 or 2 diabetes, treated with insulin and oral hypoglycaemic drugs 6. Patients with type 2 diabetes, treated with diet alone, can be included in the study 7. Patients taking weight loss medications (e.g. sibutramine, orlistat, rimonabant) and/or history of bariatric surgery 8. Use of hormonal therapies (estrogen, thyroxine, progesterone)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adherence to the low-calorie diet measured using a self-assessment questionnaire based on a 5-point Likert scale to assess compliance with Cinchona intake, and adherence to diet after 4 and 8 weeks 2. Feeling of satiety measured using a self-assessment questionnaire based on a 5-point Likert scale to assess compliance with Cinchona intake, and adherence to diet after 4 and 8 weeks 3. Negative effects measured using a self-assessment questionnaire based on a 5-point Likert scale to assess compliance with Cinchona intake, and adherence to diet after 4 and 8 weeks 4. Serum concentrations of gastrointestinal hormones cholecystokinin and ghrelin measured using Dot-Blot methods after two months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures following are assessed at 0, 4 and 8 weeks: 1. Anthropometric variables measured using height, weight, and waist circumference assessments 2. Body composition measured using bioimpedance analysis (BIA) with a 50 kHz tetrapolar bioelectrical impedance analyser (BIA 101 RJL, Akern Bioresearch, Florence, Italy). Total body water, fat mass and fat-free mass are extrapolated from the resistance and reactance values obtained with the BIA using the specific predictive equations 3. Plasma total cholesterol measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 4. High-density lipoprotein-cholesterol (HDL) measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 5. Low-density lipoprotein-cholesterol (LDL) measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 6. Triglyceride levels measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 7. Aspartate transaminase (AST) measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 8. Creatine levels measured using a Diacron International Free Carpe Diem spectrophotometer (Grosseto, Italy), and commercially available kits from Diacron International 9. Serum cholecystokinin and ghrelin levels measured using commercial active ELISA kits (Hangzhou East Biopharm Co, LTD, USA) | — |
Countries
Italy
Contacts
Public ContactBarbara De Conno
Outcome results
None listed