NCT04321590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

March 23, 2020

Last Update Submit

March 24, 2020

Conditions

Overweight and Obesity

Keywords

HydroxycinnamatesBeta-glucanGreen coffee bean extractDietary supplement

Outcome Measures

Primary Outcomes (1)

  • Anthropometric changes

    Modification in body weight/percentage body fat

    End of 6-week intervention

Secondary Outcomes (1)

  • Modification in blood lipids

    End of 6-week intervention

Study Arms (4)

3 g 35% beta-glucan

EXPERIMENTAL

Supplement containing 3 g of 35% oat beta-glucan

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)

5 g 35% beta-glucan

EXPERIMENTAL

Supplement containing 5 g of 35% oat beta-glucan

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)

3 g 70% beta-glucan

EXPERIMENTAL

Supplement containing 3 g of 70% oat beta-glucan

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)

5 g 70% beta-glucan

EXPERIMENTAL

Supplement containing 5 g of 70% oat beta-glucan

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)

Interventions

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)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

Also known as: 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-
3 g 35% beta-glucan3 g 70% beta-glucan5 g 35% beta-glucan5 g 70% beta-glucan

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

beta-glucan, (1-3)(1-4)-

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Bravo, Biologist

    Research Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Blind sachets
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, parallel, double blind study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

September 11, 2017

Primary Completion

October 20, 2017

Study Completion

October 20, 2017

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)