ObesityBEBESANONCT04016337
Evaluation of New Beverages Rich in Bioactive Compounds for the Modulation of Energetic Metabolism in Overweight Adults
A study testing Beverages in people with Obesity and Inflammation, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
During last decades, an excessive intake of sugars has been observed in westernized countries, mainly due to the consumption of sugar-rich soft drinks. Epidemiological studies have pointed out a positive correlation between the consumption of such drinks and the risk of obesity, diabetes, and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammation, Insulin Sensitivity
- What is being tested?
- Beverages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 31 Aug 2018
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers,
- body mass index (BMI) between 25 - 29.9 kg/m2 (overweight according to WHO criteria)
- 35-55 years,
- absence of disease.
Who cannot join
- Hypertension
- Dislipemia
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluación Del Efecto de Bebidas Ricas en Compuestos Bioactivos Para Modular el Metabolismo Energético en Adultos Con Sobrepeso
During last decades, an excessive intake of sugars has been observed in westernized countries, mainly due to the consumption of sugar-rich soft drinks. Epidemiological studies have pointed out a positive correlation between the consumption of such drinks and the risk of obesity, diabetes, and cardiovascular diseases. Therefore, there is a growing trend looking for new non-caloric alternatives (sweeteners) in order to reduce the sugar content of foodstuffs without losing their sweetness and tastefulness. However, some questions regarding sweeteners have recently arisen as their effects after long-term consumption have not been fully unravelled. They could also contribute to a higher caloric intake and to disrupt the gut microbiota. Besides seeking new alternatives for the high intake of sugar-rich drinks, there is a need for increasing the consumption of fruits and vegetables among general public. Developing new products to stretch the shelf-life of fresh fruits, preserving their nutrients, and reducing the energetic content of fruit juices should also be accomplished. In this sense, lemon juice has been proposed as an interesting ingredient in the elaboration of soft drinks due to its distinctive aroma and high nutritive value. Its combination with maqui berry juices contributes to stabilize the colour and phenolic compounds that both products contain (mainly flavanones for lemon juice and anthocyanins for maqui). The beneficial effects of these vegetal foodstuffs and their phenolic substances on glucose intolerance have been reported.The aim of BEBESANO is studying the beneficial effects of sugar-free, rich-in-phytochemicals drink consumption on postprandial hyperglycaemia, in order to provide alternatives to excessive sugar intake and counteract the postprandial response linked to sugar consumption in subjects with low levels of chronic inflammation such as overweight people. Moreover, BEBESANO will shed light on the interactions of food constituents with the main pathways involved in the lipid and glucose metabolism, oxidative stress, inflammation, and hormonal regulation in overweight population.
Read the detailed description
The effect of the consumption of fruit-based drinks, sweetened and rich in bioactive compounds has been evaluated in acute and chronic clinical studies. They have been carried out at the Catholic University of Murcia, in accordance with the Helsinki Declaration of Human Studies and approved by the official Ethical Committee of Clinical Studies (CEIC).
All participants were informed on the characteristics of the study and they signed the written-informed consent. Dietetic and life style habits were recorded from all participants. There were no drop-outs during the whole period of the study and no adverse effects were reported. Safety clinical parameters (hepatic enzymes, renal function) were measured as well.
Acute study The acute study has determined markers of intake such as metabolites generated from ingested polyphenolic compounds, as well as markers of effect, such as markers of inflammatory processes, oxidative stress, glycemic and lipid homeostasis and hormones. Specifically, the analysis of incretines in plasma using LC-MS techniques has been included.
A double-blind, randomized, cross-over clinical study has been conducted in a population of 20 overweight individuals. After an initial phase of 3 days of wash-out with a strict diet free of polyphenols and added sugars, 330 mL of the problem drink was administered on fasting conditions:
- Drink made with lemon and maqui and sweetened with saccharose
- Drink made with lemon and maqui and sweetened with sucralose
- Drink made with lemon and maqui and sweetened with stevia
Blood samples were then taken at various times (0, 15, 30, 60, 90, 120, 210 minutes). Urine samples were collected 24 hours earlier (0 point) as well as in 0-4, 4-8, 8-12, 12-24 h tranches.
After 7 days, the process was repeated again, for each volunteer to take another drink, until all the drinks were consumed by all the volunteers.
Chronic study Prolonged consumption of beverages over several weeks will allow the later modification markers, such as parameters related to inflammation or oxidative status and long-term hormonal response, to be evaluated.
The trial is randomized, double-blind, parallel, with 3 groups of 46 subjects each. The groups were randomized stratified by sex, BMI, and age. Recruitment has taken place at various Health Centers and at UCAM. Those who are able to participate have been informed of the study and asked to sign informed consent.
The study includes beverages already studied in acute intervention:
- Drink made with lemon and maqui and sweetened with saccharose
- Drink made with lemon and maqui and sweetened with sucralose
- Drink made with lemon and maqui and sweetened with stevia
Participants were advised not to change their dietary habits during the study period.
Each individual was given a type of drink (330 mL/day) for 60 days. Blood samples were taken, as well as 24h-urine, at day 0 and at the end of the study (60 days), to perform the various assessments.
- Conditions
- Obesity, Inflammation, Insulin Sensitivity
- Being tested
- Beverages
- Keywords
- sweeteners, stevia, sucralose, polyphenols, maqui, bioavailability, inflammation, gut hormones, biomarkers
- Medical subject headings
- Obesity, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeveragesDietary supplement
The beverages were all made with lemon and maqui extracts, and different sweeteners
| Study group | Role | What they receive |
|---|---|---|
| Intervention with beverage added with sucralose | Experimental | A beverage (330 mL) made with lemon and maqui extracts and sweetened with sucralose was taken by participants, during 60 days. Beverages were made in a semi-industrial process in a pilot plant. Microbiological tests, quality controls and shelf-life assays were performed following legislation on beverages.
Concentrations of lemon and maqui extract are under industrial secret. The sweetener sucralose was added within the ranges established by law as maximums.
The beverage was carried out in the pilot plant of a company (Nutracitrus) with all the safety systems, tested by an external lab (Ecosur), apart from the routine controls themselves.
All ingredients were suitable for consumption and purchased from different companies with their respective certificates and conservation was at 5 º C for a maximum of 7 days, prior to administration to volunteers. Receives: Dietary Supplement: Beverages |
| Intervention with beverage added with saccharose | Experimental | A beverage (330 mL) made with lemon and maqui extracts and sweetened with saccharose was taken by participants, during 60 days. Beverages were made in a semi-industrial process in a pilot plant. Microbiological tests, quality controls and shelf-life assays were performed following legislation on beverages.
Concentrations of lemon and maqui extract are under industrial secret. The sweetener saccharose was added within the ranges established by law as maximums.
The beverage was carried out in the pilot plant of a company (Nutracitrus) with all the safety systems, tested by an external lab (Ecosur), apart from the routine controls themselves.
All ingredients were suitable for consumption and purchased from different companies with their respective certificates and conservation was at 5 º C for a maximum of 7 days, prior to administration to volunteers. Receives: Dietary Supplement: Beverages |
| Intervention with beverage added with stevia | Experimental | A beverage (330 mL) made with lemon and maqui extracts and sweetened with stevia extract was taken by participants, during 60 days. Beverages were made in a semi-industrial process in a pilot plant. Microbiological tests, quality controls and shelf-life assays were performed following legislation on beverages.
Concentrations of lemon and maqui extract are under industrial secret. The sweetener stevia was added within the ranges established by law as maximums.
The beverage was carried out in the pilot plant of a company (Nutracitrus) with all the safety systems, tested by an external lab (Ecosur), apart from the routine controls themselves.
All ingredients were suitable for consumption and purchased from different companies with their respective certificates and conservation was at 5 º C for a maximum of 7 days, prior to administration to volunteers. Receives: Dietary Supplement: Beverages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in markers of inflammation (cytokines)
Plasma levels of IL-6, TNF-alfa, IL-10
Measured: Changes observed from baseline at day 0 compared to 60 days
Changes in markers of inflammation (c-reactive protein)
Plasma levels of c-reactive protein (mg/dL)
Measured: Changes observed from baseline at day 0 compared to 60 days
Changes in markers of lipid metabolism
Plasma concentrations of Total cholesterol, LDL, HDL, Triglycerides
Measured: Changes observed from baseline at day 0 compared to 60 days
Changes in markers of glycemic metabolism
Plasma levels of insulin and glucose
Measured: Changes observed from baseline at day 0 compared to 60 days
Insulin resistance
Insulin and glucose levels will be combined to report HOMA index
Measured: Changes observed from baseline at day 0 compared to 60 days
Changes in hormone response
Plasma levels of leptin, ghrelin
Measured: Changes observed from baseline at day 0 compared to 60 days
Changes in anthropometric parameters
weight and height will be combined to report BMI in kg/m^2
Measured: Changes observed from baseline at day 0 compared to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Sep 2017
- Primary completion30 Mar 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- The chronic study consisted on a 60 days consumption of a beverage (330 mL) made with lemon and maqui and added a particular sweetener.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Spain
- Responsible party
- Principal investigator, Débora Villaño, Universidad Católica San Antonio de Murcia
- Investigators
- Débora Villaño Valencia, PhD, Principal investigator, Universidad Católica de Murcia (UCAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016337
- Sponsor's protocol ID
- AGL2016-75332-C2-2-R
- Acronym
- BEBESANO
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villano D, Zafrilla P, Garcia-Viguera C, Dominguez-Perles R. A UHPLC/MS/MS method for the analysis of active and inactive forms of GLP-1 and GIP incretins in human plasma. Talanta. 2022 Jan 1;236:122806. doi: 10.1016/j.talanta.2021.122806. Epub 2021 Aug 19.
PubMed 34635208
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluación Del Efecto de Bebidas Ricas en Compuestos Bioactivos Para Modular el Metabolismo Energético en Adultos Con Sobrepeso
- ClinicalTrials.gov ID
- NCT04016337
- Acronym / sponsor ID
- BEBESANO / AGL2016-75332-C2-2-R
- Conditions
- Obesity, Inflammation, Insulin Sensitivity
- Keywords
- sweeteners, stevia, sucralose, polyphenols, maqui, bioavailability, inflammation, gut hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- National Research Council, Spain
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 Jul 2019 (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.
During last decades, an excessive intake of sugars has been observed in westernized countries, mainly due to the consumption of sugar-rich soft drinks. Epidemiological studies have pointed out a positive correlation between the consumption of such drinks and the risk of obesity, diabetes, and cardiovascular diseases. Therefore, there is a growing trend looking for new non-caloric alternatives (sweeteners) in order to reduce the sugar content of foodstuffs without losing their sweetness and tastefulness. However, some questions regarding sweeteners have recently arisen as their effects after long-term consumption have not been fully unravelled. They could also contribute to a higher caloric intake and to disrupt the gut microbiota. Besides seeking new alternatives for the high intake of sugar-rich drinks, there is a need for increasing the consumption of fruits and vegetables among general public. Developing new products to stretch the shelf-life of fresh fruits, preserving their nutrients, and reducing the energetic content of fruit juices should also be accomplished. In this sense, lemon juice has been proposed as an interesting ingredient in the elaboration of soft drinks due to its distinctive aroma and high nutritive value. Its combination with maqui berry juices contributes to stabilize the colour and phenolic compounds that both products contain (mainly flavanones for lemon juice and anthocyanins for maqui). The beneficial effects of these vegetal foodstuffs and their phenolic substances on glucose intolerance have been reported.The aim of BEBESANO is studying the beneficial effects of sugar-free, rich-in-phytochemicals drink consumption on postprandial hyperglycaemia, in order to provide alternatives to excessive sugar intake and counteract the postprandial response linked to sugar consumption in subjects with low levels of chronic inflammation such as overweight people. Moreover, BEBESANO will shed light on the interactions of food constituents with the main pathways involved in the lipid and glucose metabolism, oxidative stress, inflammation, and hormonal regulation in overweight population.
Detailed description
The effect of the consumption of fruit-based drinks, sweetened and rich in bioactive compounds has been evaluated in acute and chronic clinical studies. They have been carried out at the Catholic University of Murcia, in accordance with the Helsinki Declaration of Human Studies and approved by the official Ethical Committee of Clinical Studies (CEIC).
All participants were informed on the characteristics of the study and they signed the written-informed consent. Dietetic and life style habits were recorded from all participants. There were no drop-outs during the whole period of the study and no adverse effects were reported. Safety clinical parameters (hepatic enzymes, renal function) were measured as well.
Acute study The acute study has determined markers of intake such as metabolites generated from ingested polyphenolic compounds, as well as markers of effect, such as markers of inflammatory processes, oxidative stress, glycemic and lipid homeostasis and hormones. Specifically, the analysis of incretines in plasma using LC-MS techniques has been included.
A double-blind, randomized, cross-over clinical study has been conducted in a population of 20 overweight individuals. After an initial phase of 3 days of wash-out with a strict diet free of polyphenols and added sugars, 330 mL of the problem drink was administered on fasting conditions:
- Drink made with lemon and maqui and sweetened with saccharose
- Drink made with lemon and maqui and sweetened with sucralose
- Drink made with lemon and maqui and sweetened with stevia
Blood samples were then taken at various times (0, 15, 30, 60, 90, 120, 210 minutes). Urine samples were collected 24 hours earlier (0 point) as well as in 0-4, 4-8, 8-12, 12-24 h tranches.
After 7 days, the process was repeated again, for each volunteer to take another drink, until all the drinks were consumed by all the volunteers.
Chronic study Prolonged consumption of beverages over several weeks will allow the later modification markers, such as parameters related to inflammation or oxidative status and long-term hormonal response, to be evaluated.
The trial is randomized, double-blind, parallel, with 3 groups of 46 subjects each. The groups were randomized stratified by sex, BMI, and age. Recruitment has taken place at various Health Centers and at UCAM. Those who are able to participate have been informed of the study and asked to sign informed consent.
The study includes beverages already studied in acute intervention:
- Drink made with lemon and maqui and sweetened with saccharose
- Drink made with lemon and maqui and sweetened with sucralose
- Drink made with lemon and maqui and sweetened with stevia
Participants were advised not to change their dietary habits during the study period.
Each individual was given a type of drink (330 mL/day) for 60 days. Blood samples were taken, as well as 24h-urine, at day 0 and at the end of the study (60 days), to perform the various assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The chronic study consisted on a 60 days consumption of a beverage (330 mL) made with lemon and maqui and added a particular sweetener.
| Arm | Type | Receives |
|---|---|---|
| Intervention with beverage added with sucralose | Experimental | Dietary Supplement: BeveragesA beverage (330 mL) made with lemon and maqui extracts and sweetened with sucralose was taken by participants, during 60 days. Beverages were made in a semi-industrial process in a pilot plant. Microbiological tests, quality controls and shelf-life assays were performed following legislation on beverages. Concentrations of lemon and maqui extract are under industrial secret. The sweetener sucralose was added within the ranges established by law as maximums. The beverage was carried out in the pilot plant of a company (Nutracitrus) with all the safety systems, tested by an external lab (Ecosur), apart from the routine controls themselves. All ingredients were suitable for consumption and purchased from different companies with their respective certificates and conservation was at 5 º C for a maximum of 7 days, prior to administration to volunteers. |
| Intervention with beverage added with saccharose | Experimental | Dietary Supplement: BeveragesA beverage (330 mL) made with lemon and maqui extracts and sweetened with saccharose was taken by participants, during 60 days. Beverages were made in a semi-industrial process in a pilot plant. Microbiological tests, quality controls and shelf-life assays were performed following legislation on beverages. Concentrations of lemon and maqui extract are under industrial secret. The sweetener saccharose was added within the ranges established by law as maximums. The beverage was carried out in the pilot plant of a company (Nutracitrus) with all the safety systems, tested by an external lab (Ecosur), apart from the routine controls themselves. All ingredients were suitable for consumption and purchased from different companies with their respective certificates and conservation was at 5 º C for a maximum of 7 days, prior to administration to volunteers. |
| Intervention with beverage added with stevia | Experimental | Dietary Supplement: BeveragesA beverage (330 mL) made with lemon and maqui extracts and sweetened with stevia extract was taken by participants, during 60 days. Beverages were made in a semi-industrial process in a pilot plant. Microbiological tests, quality controls and shelf-life assays were performed following legislation on beverages. Concentrations of lemon and maqui extract are under industrial secret. The sweetener stevia was added within the ranges established by law as maximums. The beverage was carried out in the pilot plant of a company (Nutracitrus) with all the safety systems, tested by an external lab (Ecosur), apart from the routine controls themselves. All ingredients were suitable for consumption and purchased from different companies with their respective certificates and conservation was at 5 º C for a maximum of 7 days, prior to administration to volunteers. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy volunteers,
- body mass index (BMI) between 25 - 29.9 kg/m2 (overweight according to WHO criteria)
- 35-55 years,
- absence of disease.
Key exclusion criteria (3 listed)
- Hypertension
- Dislipemia
- Smoking
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 |
|---|---|---|
| BeveragesThe beverages were all made with lemon and maqui extracts, and different sweeteners | Dietary supplement | Intervention with beverage added with saccharose, Intervention with beverage added with stevia, Intervention with beverage added with sucralose |
Primary outcome
Changes in markers of inflammation (cytokines)
Time frame: Changes observed from baseline at day 0 compared to 60 days
Plasma levels of IL-6, TNF-alfa, IL-10
Changes in markers of inflammation (c-reactive protein)
Time frame: Changes observed from baseline at day 0 compared to 60 days
Plasma levels of c-reactive protein (mg/dL)
Changes in markers of lipid metabolism
Time frame: Changes observed from baseline at day 0 compared to 60 days
Plasma concentrations of Total cholesterol, LDL, HDL, Triglycerides
Changes in markers of glycemic metabolism
Time frame: Changes observed from baseline at day 0 compared to 60 days
Plasma levels of insulin and glucose
Insulin resistance
Time frame: Changes observed from baseline at day 0 compared to 60 days
Insulin and glucose levels will be combined to report HOMA index
Changes in hormone response
Time frame: Changes observed from baseline at day 0 compared to 60 days
Plasma levels of leptin, ghrelin
Changes in anthropometric parameters
Time frame: Changes observed from baseline at day 0 compared to 60 days
weight and height will be combined to report BMI in kg/m^2
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 19 Jul 2019.
- Derived from this study: PubMed 34635208Villano D, Zafrilla P, Garcia-Viguera C, Dominguez-Perles R. A UHPLC/MS/MS method for the analysis of active and inactive forms of GLP-1 and GIP incretins in human plasma. Talanta. 2022 Jan 1;236:122806. doi: 10.1016/j.talanta.2021.122806. Epub 2021 Aug 19.
- 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.
Débora Villaño Valencia, PhD principal investigator
Universidad Católica de Murcia (UCAM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverages in people with Obesity and Inflammation, run by Universidad Católica San Antonio de Murcia 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 4 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 19 Jul 2019. 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?
Changes in markers of inflammation (cytokines) (time frame: Changes observed from baseline at day 0 compared to 60 days). The study lists 7 primary outcomes in all. 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 NCT04016337, which also lists 1 linked publication.
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 19 Jul 2019.