Overweight and ObesityOBHEALTH_PSNCT04321590

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

A study testing 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) in people with Overweight and Obesity, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity
What is being tested?: 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)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSpain
Study dates: 11 Sep 2017to 20 Oct 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Madrid, 28040

Other trials in Spain

About this study

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

Read the 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.

Conditions: Overweight and Obesity
Being tested: 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)
Keywords: Hydroxycinnamates, Beta-glucan, Green coffee bean extract, Dietary supplement
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
Also called 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-
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

Study groups in NCT04321590
Study group	Role	What they receive
3 g 35% beta-glucan	Experimental	Supplement containing 3 g of 35% oat beta-glucan Receives: 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 Receives: 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 Receives: 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 Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

Anthropometric changes
Modification in body weight/percentage body fat
Measured: End of 6-week intervention

Secondary outcomes (1)

Modification in blood lipids
Change in total or LDL-cholesterol levels or triglyceride levels
Measured: End of 6-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 201720 Oct 2017

First posted25 Mar 2020
Study start11 Sep 2017
Primary completion20 Oct 2017
Study completion20 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, parallel, double blind study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04321590
Sponsor's protocol ID: AGL2015-69986-R_PS
Acronym: OBHEALTH_PS
Status last verified: Mar 2020
First submitted: 23 Mar 2020
Last updated: 25 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of New Products Combining Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity and Associated Dysfunctions (Hyperglycemia and Dyslipemia)
ClinicalTrials.gov ID: NCT04321590
Acronym / sponsor ID: OBHEALTH_PS / AGL2015-69986-R_PS
Conditions: Overweight and Obesity
Keywords: Hydroxycinnamates, Beta-glucan, Green coffee bean extract, Dietary supplement
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Instituto de Ciencia y Tecnología de Alimentos y NutriciónOther government
Collaborators: Ministerio de Economía y Competitividad, Spain
Study start: 11 Sep 2017 (actual)
Primary completion: 20 Oct 2017 (actual)
Study completion: 20 Oct 2017 (actual)
First posted: 25 Mar 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
Model description: Randomized, parallel, double blind study

Arm	Type	Receives
3 g 35% beta-glucan	Experimental	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)Supplement containing 3 g of 35% oat beta-glucan
5 g 35% beta-glucan	Experimental	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)Supplement containing 5 g of 35% oat beta-glucan
3 g 70% beta-glucan	Experimental	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)Supplement containing 3 g of 70% oat beta-glucan
5 g 70% beta-glucan	Experimental	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)Supplement containing 5 g of 70% oat beta-glucan

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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)Also: 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-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	Dietary supplement	3 g 35% beta-glucan, 3 g 70% beta-glucan, 5 g 35% beta-glucan, 5 g 70% beta-glucan

Primary outcome

Anthropometric changes
Time frame: End of 6-week intervention
Modification in body weight/percentage body fat

1 secondary outcome

Modification in blood lipids
Time frame: End of 6-week intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
Individual participant dataSharing planned: No

Related trials for Overweight and Obesity

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Bravo, Biologist principal investigator

Research Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anthropometric changes (time frame: End of 6-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.