Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04321590
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2020-03-23
Brief Title:
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study OBHEALTH_PS
Sponsor:
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Organization:
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study Overview
Official Title:
Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions Hyperglycemia and Dyslipemia
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBHEALTH_PS
Brief Summary:
Randomized double blind parallel study to assess the effect of a dietary supplement combining polyphenols hydroxycinnamates from green coffee and a soluble dietary fiber oat beta-glucans in obeseoverweight subjects
Detailed Description:
This pilot study intends to select the best combination of beta-glucan and a green coffee bean phenolic extract Four different supplements were formulated containing 3 or 5 g of two types of beta-glucan with 35 and 70 b-glucan content together with 600 mg of the green coffee bean extract Blind sachets were prepared containing half the daily dose of the supplement
60 overweightobese male and female volunteers BMI 25-35 kgm2 18-60 y old were recruited and randomly assigned to one of the four intervention groups Volunteers were instructed to consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily during 6 weeks
At the beginning and at the end of the study volunteers came to the Human Nutrition Unit at the research center after an overnight fast Urine and blood samples were obtained blood pressure was measured and anthropometric measurements were performed Dietary and physical activity records were collected
60 overweightobese male and female volunteers BMI 25-35 kgm2 18-60 y old were recruited and randomly assigned to one of the four intervention groups Volunteers were instructed to consume one sachet half an hour before lunch and dinner dissolved in 250 mL water daily during 6 weeks
At the beginning and at the end of the study volunteers came to the Human Nutrition Unit at the research center after an overnight fast Urine and blood samples were obtained blood pressure was measured and anthropometric measurements were performed Dietary and physical activity records were collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None