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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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)
Sponsored by
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Hydroxycinnamates, Beta-glucan, Green coffee bean extract, Dietary supplement

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Smokers
  • Pregnant women
  • Medication/consumption of vitamins, dietary supplements, etc.

Sites / Locations

  • Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

3 g 35% beta-glucan

5 g 35% beta-glucan

3 g 70% beta-glucan

5 g 70% beta-glucan

Arm Description

Supplement containing 3 g of 35% oat beta-glucan

Supplement containing 5 g of 35% oat beta-glucan

Supplement containing 3 g of 70% oat beta-glucan

Supplement containing 5 g of 70% oat beta-glucan

Outcomes

Primary Outcome Measures

Anthropometric changes
Modification in body weight/percentage body fat

Secondary Outcome Measures

Modification in blood lipids
Change in total or LDL-cholesterol levels or triglyceride levels

Full Information

First Posted
March 23, 2020
Last Updated
March 24, 2020
Sponsor
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Collaborators
Ministerio de Economía y Competitividad, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04321590
Brief Title
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 obese/overweight 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Hydroxycinnamates, Beta-glucan, Green coffee bean extract, Dietary supplement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel, double blind study
Masking
ParticipantInvestigator
Masking Description
Blind sachets
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 g 35% beta-glucan
Arm Type
Experimental
Arm Description
Supplement containing 3 g of 35% oat beta-glucan
Arm Title
5 g 35% beta-glucan
Arm Type
Experimental
Arm Description
Supplement containing 5 g of 35% oat beta-glucan
Arm Title
3 g 70% beta-glucan
Arm Type
Experimental
Arm Description
Supplement containing 3 g of 70% oat beta-glucan
Arm Title
5 g 70% beta-glucan
Arm Type
Experimental
Arm Description
Supplement containing 5 g of 70% oat beta-glucan
Intervention Type
Dietary Supplement
Intervention Name(s)
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)
Other Intervention Name(s)
35% oat beta-glucan (PromOat(R)Beta Glucan from Tite&Lile; 70% beta-glucan from Garuda Int. Ltd.; green coffee bean extract from Pharmafoods S-L-
Intervention Description
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
Primary Outcome Measure Information:
Title
Anthropometric changes
Description
Modification in body weight/percentage body fat
Time Frame
End of 6-week intervention
Secondary Outcome Measure Information:
Title
Modification in blood lipids
Description
Change in total or LDL-cholesterol levels or triglyceride levels
Time Frame
End of 6-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Overweight/obese subjects (BMI 25-35 kg/m2) Exclusion Criteria: Smokers Pregnant women Medication/consumption of vitamins, dietary supplements, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Bravo, Biologist
Organizational Affiliation
Research Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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