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

NCT ID: NCT04321590

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2017-10-20

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel, double blind study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Blind sachets

Study Groups

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3 g 35% beta-glucan

Supplement containing 3 g of 35% oat beta-glucan

Group Type EXPERIMENTAL

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)

Intervention Type DIETARY_SUPPLEMENT

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

5 g 35% beta-glucan

Supplement containing 5 g of 35% oat beta-glucan

Group Type EXPERIMENTAL

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)

Intervention Type DIETARY_SUPPLEMENT

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

3 g 70% beta-glucan

Supplement containing 3 g of 70% oat beta-glucan

Group Type EXPERIMENTAL

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)

Intervention Type DIETARY_SUPPLEMENT

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

5 g 70% beta-glucan

Supplement containing 5 g of 70% oat beta-glucan

Group Type EXPERIMENTAL

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)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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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-

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Smokers
* Pregnant women
* Medication/consumption of vitamins, dietary supplements, etc.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role collaborator

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

OTHER_GOV

Sponsor Role lead

Responsible Party

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Laura Bravo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Bravo, Biologist

Role: PRINCIPAL_INVESTIGATOR

Research Professor

Locations

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Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AGL2015-69986-R_PS

Identifier Type: -

Identifier Source: org_study_id

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