Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)

Overweight and Obesity Clinical Trial

— OBHEALTH_PS  

Official title:

Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321590
• Other study ID #: AGL2015-69986-R_PS
• Status: Completed
• Phase: N/A
• Start date: September 11, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: March 2020
• Source: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 obese/overweight subjects.

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 overweight/obese male and female volunteers (BMI 25-35 kg/m2, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Overweight/obese subjects (BMI 25-35 kg/m2)

Exclusion Criteria:

• Smokers

• Pregnant women

• Medication/consumption of vitamins, dietary supplements, etc.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)
Dose-response study on the effect of two different types of oat beta-glucan with different b-glucan content (35% vs. 70%) in combination with a green coffee bean extract rich in polyphenols. Consumption of 2 sachets/day (providing 3 or 5 g/d beta-glucan plus 600 mg polyphenols) during 6 weeks

Locations

Country	Name	City	State
Spain	Instituto de Ciencia y Tecnología de Alimentos y Nutrición	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric changes	Modification in body weight/percentage body fat	End of 6-week intervention
Secondary	Modification in blood lipids	Change in total or LDL-cholesterol levels or triglyceride levels	End of 6-week intervention