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Overweight and ObesityNCT03679689

Metabolism Effects of Artificially Sweetened Beverages Restriction

A study testing artificially sweetened beverages in people with Overweight and Obesity, run by Monica Flores-Muñoz at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The consumption of artificially sweetened beverages increases glucose and insulin concentrations in blood, body weight and waist circumference. However, the effect of restricting the consumption of these beverages on metabolism is unknown. Read more about this study

Who is it for?
Ages 19 to 27 years
Conditions the study is for
Overweight and Obesity
What is being tested?
artificially sweetened beverages
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteMexico
Study dates
1 Feb 2017to 31 Jan 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 19 to 27 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • BMI between 25 kg /m² to 36 kg / m², with low intensity physical activities and consumers of at least 3 portions of artificially sweetened beverages per week

Who cannot join

  • students with hyper or hypothyroidism, pregnant women and those who perform high to moderate physical activities

Trial locations and contacts

1 site in 1 country.

Mexico1 site
  • Universidad Veracruzana

    Xalapa, Veracruz, 91190

Other trials in Mexico

About this study

Official title: Improvement of Biochemical Markers After Reduction of Artificially Sweetened Beverages Consumption. A Clinical Randomised Trial

The consumption of artificially sweetened beverages increases glucose and insulin concentrations in blood, body weight and waist circumference. However, the effect of restricting the consumption of these beverages on metabolism is unknown. Our objective is to evaluate the effect of reducing artificially sweetened beverages consumption on the metabolism of overweight and obese young adults. A randomized, blind, controlled 12 week clinical trial will be performed on overweight and obese young adults. Young adults, consumers of artificially sweetened beverages, will be randomly assign to either Control group (no changes in their alimentary habits) or Intervention group (no intake of artificially sweetened beverages). The percentage change between 0 and 12 weeks of anthropometric variables, fasting plasma concentrations of glucose, triglycerides, insulin and cholesterol will be calculated and compared.

Read the detailed description

Overweight and obesity are public health problems across the world. In 2016 the World Health Organization estimated that over 1900 million adults were diagnosed as overweight or obese. These pathologies result from the interaction between many factors, mainly poor alimentary habits and a sedentary lifestyle. The high consumption of simple carbohydrates and sugar sweetened beverages, like soft drinks, juices and flavored water, is considered one of the main factors that contribute to the increase in incidence and prevalence of overweight and obesity. A high consumption of simple carbohydrates promotes an increase in blood glucose concentrations, which facilitates the formation of triglycerides that are subsequently stored in adipose tissue.

To decrease the caloric intake attributable to sugar sweetened beverages, the food industry promotes the commercialization of artificially sweetened beverages. These products have the same organoleptic features than sugar sweetened beverages, with the perks of having a minimum or no caloric contribution at all, not affecting the energy metabolism.

Nonetheless, recent studies relate the consumption of artificially sweetened beverages with a deregulation of the metabolic homeostasis, promoting physiological modifications. Likewise, it was reported that artificial sweeteners increased glucose and insulin concentrations in blood, which is detrimental to health, especially in population with a pre-existing risk of developing non-infectious diseases, such as overweight and obesity. For this reason we will evaluate the effect of reducing the consumption of artificially sweetened beverages (ASBs) in overweight and obese young adults.

This study is a single-blind randomized clinical trial controlled with a parallel group. Young adults, students of the University of Veracruz, are randomly allocated to a 12-week no consumption of artificially sweetened beverages intervention or control group.

All the volunteers that satisfy the inclusion criteria will be asked to sign the informed consent before the start of the study. The volunteers will be randomly allocated in control or intervention group (1:1 allocation ratio to each group) in blocks of 2 using Microsoft Office Excell. Nobody involved with data acquisition will have access to the assignment of the participants. Once randomly assigned, a blood sample and anthropometric variables will be taken to establish basal data. Participants will be interviewed to know caloric intake (24-h food recall), consumed portions and beverage consumption (Food frequency questionnaire). The intervention group will not be allowed to consume artificially sweetened beverages; however, they will be allowed to consume products that do not contain artificial sweeteners in their formulae. For the control group artificially sweetened beverages consumption will not be modified. Both groups will continue with their normal food habits. Anthropometric measures, 24-h food recall and food frequency questionnaire data will be collected at week 0, 6 and 12. A blood sample will be taken at week 0 and 12. In order to categorize the physical activity a, previously validated, questionnaire will applied. Using this instrument, physical level will be divided in low, moderate and high.

For comparison between groups at baseline measurements we will use Student´s t-test and Mann- Whitney U test based on data distribution. In order to compare changes between baseline and 12 weeks measurements, the percentage change will be calculate, and pertinent tests applied. A p value <0.05 will be considered statistically significant.

Being tested
artificially sweetened beverages
Keywords
Non-Nutritive sweeteners, Artificially sweeteners, obesity, overweight
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • artificially sweetened beveragesDietary supplement

    artificially sweetened beverages restriction

Study groups in NCT03679689
Study groupRoleWhat they receive
Control groupNo interventionno changes in their alimentary habits
intervention groupExperimentalno intake of artificially sweetened beverages
Receives: Dietary Supplement: artificially sweetened beverages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucose in mg/dl

    Fasting blood samples will be analyzed for plasma concentrations

    Measured: 12 weeks

  2. Triglycerides in mg/dl

    Fasting blood samples will be analyzed for plasma concentrations

    Measured: 12 weeks

  3. Insulin

    Fasting blood samples will be analyzed for plasma concentrations

    Measured: 12 weeks

  4. Cholesterol in mg/dl

    Fasting blood samples will be analyzed for plasma concentrations

    Measured: 12 weeks

Secondary outcomes (4)
  1. Micro and macronutrients consumed during the 12 week study (in grams)

    24-hour recall

    Measured: 12 weeks

  2. Weight in kilograms

    bioelectrical impedance

    Measured: 12 weeks

  3. Body fat percentage

    bioelectrical impedance

    Measured: 12 weeks

  4. Portions consumed of artificially sweetened beverages (1portion=250ml)

    food frequency instrument

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2018
  2. Study start1 Feb 2017
  3. Primary completion1 Oct 2018
  4. Study completion31 Jan 2019

Resources

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
A randomized, blind, controlled clinical trial
Masking
Single blind
Who is masked
Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679689
Sponsor's protocol ID
D_005/2016
Status last verified
Aug 2022
First submitted
14 Sep 2018
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bergwall S, Johansson A, Sonestedt E, Acosta S. High versus low-added sugar consumption for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2022 Jan 5;1(1):CD013320. doi: 10.1002/14651858.CD013320.pub2.

    PubMed 34986271

Questions about this trial

What is this clinical trial studying?

A study testing artificially sweetened beverages in people with Overweight and Obesity, run by Monica Flores-Muñoz at 1 site in Mexico.

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 1 inclusion and 1 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 5 Aug 2022. 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 Mexico. 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?

Glucose in mg/dl (time frame: 12 weeks). The study lists 4 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 NCT03679689, 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 5 Aug 2022.

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Clinical Trial NCT03679689 | AzTrials