NCT03679689

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

September 14, 2018

Last Update Submit

August 4, 2022

Conditions

Overweight and Obesity

Keywords

Non-Nutritive sweetenersArtificially sweetenersobesityoverweight

Outcome Measures

Primary Outcomes (4)

  • Glucose in mg/dl

    Fasting blood samples will be analyzed for plasma concentrations

    12 weeks

  • Triglycerides in mg/dl

    Fasting blood samples will be analyzed for plasma concentrations

    12 weeks

  • Insulin

    Fasting blood samples will be analyzed for plasma concentrations

    12 weeks

  • Cholesterol in mg/dl

    Fasting blood samples will be analyzed for plasma concentrations

    12 weeks

Secondary Outcomes (4)

  • Micro and macronutrients consumed during the 12 week study (in grams)

    12 weeks

  • Weight in kilograms

    12 weeks

  • Body fat percentage

    12 weeks

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

    12 weeks

Study Arms (2)

Control group

NO INTERVENTION

no changes in their alimentary habits

intervention group

EXPERIMENTAL

no intake of artificially sweetened beverages

Dietary Supplement: artificially sweetened beverages

Interventions

artificially sweetened beveragesDIETARY_SUPPLEMENT

artificially sweetened beverages restriction

intervention group

Eligibility Criteria

Age19 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Veracruzana

Xalapa, Veracruz, 91190, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 34986271DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Artificially Sweetened Beverages

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Monica Flores-Muñoz, PhD

    Universidad Veracruzana

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Nobody involved with data acquisition had access to de assignment of the subjects
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized, blind, controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 20, 2018

Study Start

February 1, 2017

Primary Completion

October 1, 2018

Study Completion

January 31, 2019

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)