Overweight/ObesityOBHEALTHNCT05009615
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)
A study testing Green coffee extract, Beta glucan and Green coffee + beta-glucan in people with Overweight/Obesity and Insulin Resistance, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
Trial summary
The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight/Obesity, Insulin Resistance
- What is being tested?
- Green coffee extract, Beta glucan and Green coffee + beta-glucan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 3 Dec 2018to 14 Dec 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Men and women, with BMI between 25-35 kg/m2
- Fasting blood glucose between 6,11-6,94 mmol/L (110-125 mg/dL) and/or
- Blood glucose between 7,77-11,04 mmol/L (140-199 mg/dL) 2 h after an oral glucose overload
Who cannot join
- Having other chronic pathologies different from overweight/obesity and prediabetes.
- On prescription drugs, hormones or dietary supplements (e.g. dietary fibre, pollen, vitamin complexes, etc.)
- Vegetarian
- Smoking
- Known hypersensibility/allergy to any of the tests products
- Pregnant women
- On dietary regimen or physical training to lose weight
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Madrid, 28040
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)
The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.
Read the detailed description
In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was followed by a 4-week wash-out.
Blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. Physical activity was controlled by accelerometry (1 week during each intervention stage). Energy expenditure was measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was determined by subjective (VAS) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage.
In a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted metabolomic analysis was carried out in these samples. In these volunteers, incretins and hormones were also determined in blood samples.
- Conditions
- Overweight/Obesity, Insulin Resistance
- Being tested
- Green coffee extract, Beta glucan, Green coffee + beta-glucan
- Keywords
- Obesity, Non-communicable diseases, Polyphenols, Soluble dietary fiber, Nutraceutical
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green coffee extractDietary supplement
150 mg polyphenols from green coffee, twice daily
Beta glucanDietary supplement
2.5 g BG twice daily
Green coffee + beta-glucanDietary supplement
150 mg polyphenols from green coffee + 2.5 g BG, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Green coffee extract | Experimental | Nutraceutical containing a decaffeinated green coffee extract rich in phenolic compounds (hydroxycinnamates). Participants received powdered sachets containing 300 mg of GC extract twice daily for 8 weeks Receives: Dietary Supplement: Green coffee extract |
| Beta-glucan | Experimental | Nutraceutical containing a oat beta-glucan. Participants received powdered sachets containing 2.5 g of BG twice daily for 8 weeks Receives: Dietary Supplement: Beta glucan |
| Green coffee + Beta-glucan | Experimental | Nutraceutical containing both green coffee extract and beta-glucan. Participants received powdered sachets containing 2.5 g of BG plus 300 mg of GC extract twice daily for 8 weeks Receives: Dietary Supplement: Green coffee + beta-glucan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change of body weight (estimated 2.5 kg) at the end of the intervention
Measured: 8 weeks
Secondary outcomes (4)
Body fat percentage
Change of body fat percentage (total and visceral)
Measured: 8 weeks
Anthropometry
Change of body circumferences (waist, hip, thigh) or skin folds at the end of the intervention
Measured: 8 weeks
Insulin resistance
Change in fasting blood glucose and/or insulin levels, use to calculate homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR), beta-cell function (HOMA-beta) or quantitative insulin sensitivity check index (QUICKI) indexes. Outcome would be a modification of at least one of these indexes at the end of the intervention
Measured: 8 weeks
Blood lipids
Modification of serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol blood, triglycerides at the end of the intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start3 Dec 2018
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After a run-in period, participants were randomly allocated to one of each arm. Each intervention stage (8 weeks) was separated by a 4-week wash-out.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Sponsor type
- Other government
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Laura Bravo, Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Investigators
- Laura Bravo, Prof, Principal investigator, ICTAN-CSIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009615
- Sponsor's protocol ID
- AGL2015-69986-R
- Acronym
- OBHEALTH
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. 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
- NCT05009615
- Acronym / sponsor ID
- OBHEALTH / AGL2015-69986-R
- Conditions
- Overweight/Obesity, Insulin Resistance
- Keywords
- Obesity, Non-communicable diseases, Polyphenols, Soluble dietary fiber, Nutraceutical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y NutriciónOther government
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 17 Aug 2021 (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.
The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.
Detailed description
In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was followed by a 4-week wash-out.
Blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. Physical activity was controlled by accelerometry (1 week during each intervention stage). Energy expenditure was measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was determined by subjective (VAS) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage.
In a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted metabolomic analysis was carried out in these samples. In these volunteers, incretins and hormones were also determined in blood samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- After a run-in period, participants were randomly allocated to one of each arm. Each intervention stage (8 weeks) was separated by a 4-week wash-out.
| Arm | Type | Receives |
|---|---|---|
| Green coffee extract | Experimental | Dietary Supplement: Green coffee extractNutraceutical containing a decaffeinated green coffee extract rich in phenolic compounds (hydroxycinnamates). Participants received powdered sachets containing 300 mg of GC extract twice daily for 8 weeks |
| Beta-glucan | Experimental | Dietary Supplement: Beta glucanNutraceutical containing a oat beta-glucan. Participants received powdered sachets containing 2.5 g of BG twice daily for 8 weeks |
| Green coffee + Beta-glucan | Experimental | Dietary Supplement: Green coffee + beta-glucanNutraceutical containing both green coffee extract and beta-glucan. Participants received powdered sachets containing 2.5 g of BG plus 300 mg of GC extract twice daily for 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women, with BMI between 25-35 kg/m2
- Fasting blood glucose between 6,11-6,94 mmol/L (110-125 mg/dL) and/or
- Blood glucose between 7,77-11,04 mmol/L (140-199 mg/dL) 2 h after an oral glucose overload
Key exclusion criteria (7 listed)
- Having other chronic pathologies different from overweight/obesity and prediabetes.
- On prescription drugs, hormones or dietary supplements (e.g. dietary fibre, pollen, vitamin complexes, etc.)
- Vegetarian
- Smoking
- Known hypersensibility/allergy to any of the tests products
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 |
|---|---|---|
| Green coffee extract150 mg polyphenols from green coffee, twice daily | Dietary supplement | Green coffee extract |
| Beta glucan2.5 g BG twice daily | Dietary supplement | Beta-glucan |
| Green coffee + beta-glucan150 mg polyphenols from green coffee + 2.5 g BG, twice daily | Dietary supplement | Green coffee + Beta-glucan |
Primary outcome
Body weight
Time frame: 8 weeks
Change of body weight (estimated 2.5 kg) at the end of the intervention
4 secondary outcomes
Body fat percentage
Time frame: 8 weeks
Anthropometry
Time frame: 8 weeks
Insulin resistance
Time frame: 8 weeks
Blood lipids
Time frame: 8 weeks
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 17 Aug 2021.
- Individual participant dataSharing planned: No
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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, Prof principal investigator
ICTAN-CSIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green coffee extract, Beta glucan and Green coffee + beta-glucan in people with Overweight/Obesity and Insulin Resistance, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
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 3 inclusion and 7 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 17 Aug 2021. 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?
Body weight (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2021.