Change in Total Body Fat Mass Percentage Loss Versus Body Weight Clinical Trial
| NCT number | NCT04149158 |
| Other study ID # | SNTCT2015 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2015 |
| Est. completion date | September 2017 |
| Verified date | October 2019 |
| Source | Fytexia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study aims to evaluate effects of a 16-week supplementation with a polyphenol rich extract, Sinetrol® Xpur, on fat mass accumulation and body weight management improvement.Subjects were overweight or obese and received polyphenol supplement or placebo. A 4-week follow-up as performed to evaluate its effect after supplementation stop.
| Status | Completed |
| Enrollment | 77 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 25 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - overweight or obese (25 kg.m-2<BMI<42.5kg.m-2) - healthy Exclusion Criteria: - metabolic or chronical disease with treatments (i.e.: diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, infectious disease, asthma, anxiety and depression) - food allergy to the ingredients of the product (grapefruit, orange, caffeine, guarana) - involved in the prior 6 months in a chronic treatment program, eating disorders history, subjected to weight reduction by surgery - start or quit smoking, high alcohol consumption - pregnant, breastfeeding, wanting to have a baby, - menopausal women |
| Country | Name | City | State |
|---|---|---|---|
| Spain | UCAM | Murcia |
| Lead Sponsor | Collaborator |
|---|---|
| Fytexia |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in total body fat percentage loss versus bodyweight | week1; week16; week20 |