Study of the beneficial effects of a combination of food ingredients on cardiovascular risk factors in overweight subjects

Completed

• Conditions: Overweight patients; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN73005547
• Lead Sponsor: KitoZyme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-15
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male and female
2. Aged at least 18 years
3. Caucasian type
4. 255. Stable patient’s weight ± 5% for at least 3 last months and patient’s agreement not to change food habits during the study
6. Menopausal women without or with HRT with a stable rate for at least 3 months
7. Able to understand and to give consent
8. Compliant with treatment

Exclusion Criteria

1. Current cancer treatment
2. Diabetes
3. Severe intestinal problems
4. Autoimmune or chronic inflammatory diseases
5. Unintentional weight loss (> 10% of body weight) during the previous 6 months
6. Particular nutritional practice (vegetarians, vegans, high consumption of fiber)
7. Intake of food supplements
8. History of eating disorders (anorexia, bulimia)
9. Dieting at the time of inclusion
10. Underwent bariatric surgery
11. Consumption in the preceding 6 weeks of antibiotics or probiotics
12. Pregnancy, breastfeeding
13. Active smoker or ex-smoker for less than 2 years
14. Food allergy to one of the components of the supplement
15. Participation in another clinical study at the time of inclusion
16. Usually taking medication: anti-inflammatory drugs, corticosteroids, antiepileptics, neuroleptics, laxatives, antibiotics

Study & Design

• Study Type: Interventional
• Study Design: Not specified