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Evaluation of New Beverages Rich in Bioactive Compounds for the Modulation of Energetic Metabolism in Overweight Adults (BEBESANO)

Primary Purpose

Obesity, Inflammation, Insulin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Beverages
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring sweeteners, stevia, sucralose, polyphenols, maqui, bioavailability, inflammation, gut hormones, biomarkers

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Católica de Murcia (UCAM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intervention with beverage added with sucralose

Intervention with beverage added with saccharose

Intervention with beverage added with stevia

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in markers of inflammation (cytokines)
Plasma levels of IL-6, TNF-alfa, IL-10
Changes in markers of inflammation (c-reactive protein)
Plasma levels of c-reactive protein (mg/dL)
Changes in markers of lipid metabolism
Plasma concentrations of Total cholesterol, LDL, HDL, Triglycerides
Changes in markers of glycemic metabolism
Plasma levels of insulin and glucose
Insulin resistance
Insulin and glucose levels will be combined to report HOMA index
Changes in hormone response
Plasma levels of leptin, ghrelin
Changes in anthropometric parameters
weight and height will be combined to report BMI in kg/m^2

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
July 17, 2019
Sponsor
Universidad Católica San Antonio de Murcia
Collaborators
National Research Council, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT04016337
Brief Title
Evaluation of New Beverages Rich in Bioactive Compounds for the Modulation of Energetic Metabolism in Overweight Adults
Acronym
BEBESANO
Official Title
Evaluación Del Efecto de Bebidas Ricas en Compuestos Bioactivos Para Modular el Metabolismo Energético en Adultos Con Sobrepeso
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
Collaborators
National Research Council, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Inflammation, Insulin Sensitivity
Keywords
sweeteners, stevia, sucralose, polyphenols, maqui, bioavailability, inflammation, gut hormones, biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Beverages were provided by manufacturer with codes and no one, up to now, knows the sweetener added on each type.
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention with beverage added with sucralose
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention with beverage added with saccharose
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention with beverage added with stevia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beverages
Intervention Description
The beverages were all made with lemon and maqui extracts, and different sweeteners
Primary Outcome Measure Information:
Title
Changes in markers of inflammation (cytokines)
Description
Plasma levels of IL-6, TNF-alfa, IL-10
Time Frame
Changes observed from baseline at day 0 compared to 60 days
Title
Changes in markers of inflammation (c-reactive protein)
Description
Plasma levels of c-reactive protein (mg/dL)
Time Frame
Changes observed from baseline at day 0 compared to 60 days
Title
Changes in markers of lipid metabolism
Description
Plasma concentrations of Total cholesterol, LDL, HDL, Triglycerides
Time Frame
Changes observed from baseline at day 0 compared to 60 days
Title
Changes in markers of glycemic metabolism
Description
Plasma levels of insulin and glucose
Time Frame
Changes observed from baseline at day 0 compared to 60 days
Title
Insulin resistance
Description
Insulin and glucose levels will be combined to report HOMA index
Time Frame
Changes observed from baseline at day 0 compared to 60 days
Title
Changes in hormone response
Description
Plasma levels of leptin, ghrelin
Time Frame
Changes observed from baseline at day 0 compared to 60 days
Title
Changes in anthropometric parameters
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
Changes observed from baseline at day 0 compared to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Débora Villaño Valencia, PhD
Organizational Affiliation
Universidad Católica de Murcia (UCAM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Católica de Murcia (UCAM)
City
Guadalupe
State/Province
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34635208
Citation
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.
Results Reference
derived

Learn more about this trial

Evaluation of New Beverages Rich in Bioactive Compounds for the Modulation of Energetic Metabolism in Overweight Adults

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