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
1 other identifier
interventional
138
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Sep 2017
Shorter than P25 for not_applicable obesity
1 active site
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 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedFirst Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedJuly 19, 2019
July 1, 2019
7 months
July 2, 2019
July 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Changes in markers of inflammation (cytokines)
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)
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
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
Plasma levels of insulin and glucose
Changes observed from baseline at day 0 compared to 60 days
Insulin resistance
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
Plasma levels of leptin, ghrelin
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
Changes observed from baseline at day 0 compared to 60 days
Study Arms (3)
Intervention with beverage added with sucralose
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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.
Interventions
The beverages were all made with lemon and maqui extracts, and different sweeteners
Eligibility Criteria
You may qualify if:
- healthy volunteers,
- body mass index (BMI) between 25 - 29.9 kg/m2 (overweight according to WHO criteria)
- years,
- absence of disease.
You may not qualify if:
- Hypertension
- Dislipemia
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Católica de Murcia (UCAM)
Guadalupe, Murcia, 30107, Spain
Related Publications (1)
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.
PMID: 34635208DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Débora Villaño Valencia, PhD
Universidad Católica de Murcia (UCAM)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Beverages were provided by manufacturer with codes and no one, up to now, knows the sweetener added on each type.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 11, 2019
Study Start
September 1, 2017
Primary Completion
March 30, 2018
Study Completion
August 31, 2018
Last Updated
July 19, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share