Overweight/mild obese Nutritional, Metabolic, Endocrine
Conditions
Interventions
The product under study consists of a food supplement containing probiotics.
Half of the recruited subjects will be randomized to receive the active product and half of the recruited subjects will be
Sponsors
SynBalance srl
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Asian ethnicity 3. Aged between 18 and 45 years (including extremes) 4. Subjects overweight/mild obese (BMI between 26 and 31.9 kg/m²)* 5. Subjects with large waist (waistline >80 centimetres for women and >85 centimetres for men) 6. Subjects certifying the truthfulness of the personal data disclosed to the investigator 7. Subjects able to understand the language used in the investigation center and the information given by the investigator 8. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 9. Commitment not to change the daily routine or the lifestyle** 10. Stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study 11. Subject is under effective contraception (oral/not oral) therapy if fertile 12. Subjects informed about the test procedures who have signed a consent form and privacy policy *According to “Health standards of the People’s Republic of China”, National Health and Family Planning Commission of the People's Republic of China: Classification BMI Obese BMI = 28.0 kg/m² Overweight 24.0 kg/m² = BMI < 28.0 kg/m² Normal 18.5 kg/m² = BMI < 24.0 kg/m² Underweight BMI < 18.5 kg/m² ** Subjects will keep a food diary to ensure that they do not change their eating habits during the study
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects participating or planning to participate in other clinical trials 3. Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 4. Subjects who are currently using food supplement(s) and/or topical products with the same activity as the study product, or who haven't observed an adequate washout period since stopping use (at least one month) 5. Subjects admitted to a health or social facility 6. Subjects planning a hospitalization during the study 7. Subjects not able to be contacted in case of emergency 8. Subjects deprived of freedom by administrative or legal decision or under guardianship 9. Subjects with a history of drug, alcohol, and other substance abuse 10. Alimentary/Eating disorders (i.e., bulimia, psychogenic eating disorders, etc.) 11. Smokers 12. Subject breastfeeding, pregnant, or not willing to take necessary precautions to avoid pregnancy during the study (for women of childbearing potential) 13. Subjects with any acute, chronic, or progressive disease or skin condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study 14. Subjects that have food intolerances or food allergies or allergy to ingredients of the study product or allergy to any of the ingredients in the product under investigation 15. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Body weight (kg) at baseline, and after 56 days and 84 days of treatment 2. Body Mass Index (kg/m²) at baseline, and after 56 days and 84 days of treatment 3. Waist circumference (cm) at baseline, and after 56 days and 84 days of treatment 4. Hip circumference (cm) at baseline, and after 56 days and 84 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Obesity-related Quality of Life (ORWELL-97) at baseline, and after 56 days and 84 days of treatment 2. Blood parameters at baseline, and after 56 days and 84 days of treatment: 2.1. Total Cholesterol (mmol/l) 2.2. HDL cholesterol (mmol/l) 2.3. LDL cholesterol (mmol/l) 2.4. Triglycerides (mmol/l) 2.5. Fasting Insulin (pmoI/l) 2.6. Fasting Glucose (mmol/l) 2.7. HbA1c (mmol/l) 3. Fecal microbiome analysis at baseline, and after 84 days of treatment 4. Conicity index (CI) at baseline, and after 56 days and 84 days of treatment 5. Visceral Adiposity Index (VAI) at baseline, and after 56 days and 84 days of treatment 6. HOMA index (Homeostasis Model Assessment) at baseline, and after 56 days and 84 days of treatment 7. Self-evaluation questionnaire (polytomous question with four possible answers) after 84 days of treatment 8. Incidence and nature of Adverse Event (AE) and Serious Adverse Event (SAE) after 56 days and 84 days of treatment | — |
Countries
China, Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed