- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016337
Evaluation of New Beverages Rich in Bioactive Compounds for the Modulation of Energetic Metabolism in Overweight Adults (BEBESANO)
Evaluación Del Efecto de Bebidas Ricas en Compuestos Bioactivos Para Modular el Metabolismo Energético en Adultos Con Sobrepeso
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Murcia
-
Guadalupe, Murcia, Spain, 30107
- Universidad Católica de Murcia (UCAM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy volunteers,
- body mass index (BMI) between 25 - 29.9 kg/m2 (overweight according to WHO criteria)
- 35-55 years,
- absence of disease.
Exclusion Criteria:
- Hypertension
- Dislipemia
- Smoking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention with beverage added with sucralose
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. |
The beverages were all made with lemon and maqui extracts, and different sweeteners
|
EXPERIMENTAL: Intervention with beverage added with saccharose
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. |
The beverages were all made with lemon and maqui extracts, and different sweeteners
|
EXPERIMENTAL: Intervention with beverage added with stevia
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. |
The beverages were all made with lemon and maqui extracts, and different sweeteners
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 observed from baseline at day 0 compared to 60 days
|
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 observed from baseline at day 0 compared to 60 days
|
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 observed from baseline at day 0 compared to 60 days
|
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
|
Changes observed from baseline at day 0 compared to 60 days
|
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 observed from baseline at day 0 compared to 60 days
|
Changes in hormone response
Time Frame: Changes observed from baseline at day 0 compared to 60 days
|
Plasma levels of leptin, ghrelin
|
Changes observed from baseline at day 0 compared to 60 days
|
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
|
Changes observed from baseline at day 0 compared to 60 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Débora Villaño Valencia, PhD, Universidad Católica de Murcia (UCAM)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGL2016-75332-C2-2-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Assistance Publique - Hôpitaux de ParisCompletedDigestive InflammationFrance
-
Pamukkale UniversityCompletedPeriodontal InflammationTurkey
-
Universidade Federal do ParaCompleted
-
KLE Society's Institute of Dental SciencesCompletedRegenerative InflammationIndia
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
Oral Science International Inc.AdvarraNot yet recruiting
Clinical Trials on Beverages
-
University of AarhusCompleted
-
Fred Hutchinson Cancer CenterNational Heart, Lung, and Blood Institute (NHLBI); University of WashingtonCompletedObesity | Cardiovascular Disease | Type 2 Diabetes Mellitus | Intestinal Permeability | Low-grade Chronic InflammationUnited States
-
John SievenpiperUnknownObesity | OverweightCanada
-
Monica Flores-MuñozInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Universidad...Completed
-
Clinical Nutrition Research Center, Illinois Institute...Completed
-
Boston Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of LausanneCompletedNormal SubjectsSwitzerland
-
University of Colorado, DenverTemple UniversityCompleted
-
Singapore General HospitalAbbottWithdrawn
-
Instituto de Nutrición y Tecnología de los AlimentosUnknown