Healthy subjects with overweight or mild obesity and with metabolic syndrome. Nutritional, Metabolic, Endocrine
Conditions
Interventions
The active product is a food supplement containing Hops extract (Humulus Lupulus L.), while the placebo contains the same excipients without the active ingredients.
A restricted randomization list wil
Sponsors
ROELMI HPC S.R.L., Via Celeste Milani 24/26 – 21040 Origgio (VA), Italy
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 64 years (extremes included) 4. Subjects with overweight or mild obesity * 5. Subjects with metabolic syndrome** 6. Subjects registered with national health service 7. Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated Personnel 8. Subjects able to understand the language used in the investigation center and the information given by the Principal Investigator or designated personnel 9. Subjects able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements 10. Subjects who commit not to change their daily routine or lifestyle during the study*** 11. Subjects on 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 12. Subjects informed about the test procedures who have signed a consent form and privacy agreement. * At the recruitment, BMI between 25 kg/m² and 34.9 kg/m² (overweight and obesity class I). According to the World Health Organization (WHO) BMI Classification ** According to the International Diabetes Federation (IDF). At least three out of five required: 1. Large waist circumference (= 94 cm for males and = 80 cm for females) 2. Low HDL cholesterol levels (<40 mg/dl for males and <50 mg/dl for females) 3. High triglyceride levels (= 150 mg/dl) 4. High fasting glucose levels (= 100 mg/dl) 5. High blood pressure (= 130/85 mmHg) *** Subjects will maintain a weekly diary to record their dietary habits and physical activity
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Female subjects who consume = 140 g/week of alcohol and male subjects who consume = 210 g/week of alcohol**** 3. Subjects with any acute, chronic, or progressive disease or 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***** 4. Subjects participating or planning to participate in other clinical trials 5. Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 6. Subjects that have food intolerances or food allergies to ingredients of the study product 7. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator ****** 8. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month) 9. Subjects admitted to a health or social facility 10. Subjects planning a hospitalization during the study 11. Subjects not able to be contacted in case of emergency 12. Subjects deprived of freedom by administrative or legal decision or under guardianship 13. Subjects who have or have had a history of alcohol or drug addiction 14. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 15. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) **** According to the American Association for the Study of Liver Diseases guidelines for nonalcoholic fatty liver disease ***** Including severe hepatic or kidney disease, serious infections, and malignancies ****** Including medications to manage blood glucose levels (e.g., metformin, sulfonylureas, DPP-4 Inhibitors, GLP-1 Agonists), lipid disorders (e.g., statins, fibrates, niacin), high blood pressure (e.g., ACE Inhibitors, Angiotensin II Receptor Blockers, Beta-Blockers, Calcium Channel Blockers), as well as treatments for weight control and any food supplements intended for metabolic syndrome (MetS). Corticosteroids, antidepressants, antipsychotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Waist circumference measured using a tape (cm) at baseline, 56 and 84 days;Body weight measured using a scale (kg) at baseline, 56 and 84 days;Body Mass Index (BMI) measured using the formula: BMI = weight / height^2 at baseline, 56 and 84 days;Total cholesterol (TC) measured using blood analysis (mg/dl) at baseline, 56 and 84 days;High-density lipoprotein cholesterol (HDL-C) measured using blood analysis (mg/dl) at baseline, 56 and 84 days;Low-density lipoprotein cholesterol (LDL-C) measured using blood analysis (mg/dl) at baseline, 56 and 84 days;Triglycerides (TG) measured using blood analysis (mg/dl) at baseline, 56 and 84 days;Fasting glucose (FG) measured using blood analysis (mg/dl) at baseline, 56 and 84 days;Fasting Insulin (FI) measured using blood analysis (µU/ml) at baseline, 56 and 84 days;Glycated hemoglobin (HbA1c) measured using blood analysis (% or mmol/l) at baseline and 84 days;Previous primary outcome(s): 1. Waist circumference measured using a tape (cm) at baseline, 56 and 84 days. 2. Body weight measured using a scale (kg) at baseline, 56 and 84 days. 3. Body Mass Index (BMI) measured using the formula: BMI = weight / height^2 at baseline, 56 and 84 days. 4. Total cholesterol (TC) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. 5. High-density lipoprotein cholesterol (HDL-C) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. 6. Low-density lipoprotein cholesterol (LDL-C) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. 7. Triglycerides (TG) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. 8. Fasting glucose (FG) measured using blood analysis (mg/dl) at baseline, 56 and 84 days. 9. Fasting Insulin (FI) measured using blood analysis (µU/ml) at baseline, 56 and 84 days. 10. Glycated hemoglobin (HbA1c) measured using blood analysis (% or mmol/l) at baseline, 56 and 84 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) measured using a specific mathematical formula at baseline, 56 and 84 days.;Visceral Adiposity Index (VAI) measured using a specific mathematical formula at baseline, 56 and 84 days.;High-sensitivity C-Reactive Protein (hs-CRP) measured using blood analysis at baseline, 56 and 84 days. | — |
Countries
Italy
Contacts
Public ContactRoberta;Eleonora Villa;Spartà
;
Outcome results
None listed