Effects of Low/No Calorie Sweeteners on Glucose Tolerance

May 22, 2021 updated by: Şaziye Ecem Örkü, Acibadem University

The Effect of Regular Consumption of Low/No Calorie Sweeteners on Glycemic Response and Glucagon Like Peptide-1 Secretion in Healthy Adults: A Randomized Controlled Trial

This study aims to determine the effects of chronic exposure to some low/no calorie sweeteners (LNCS) on glucose tolerance and glucagon like peptide 1 (GLP-1) release in healthy individuals. LNCS examined in this study are saccharin, sucralose and aspartame+acesulfame-K. The amounts of LNCS given to the participants are kept similar to daily life exposure; far less than the Acceptable Daily Intakes (ADIs) levels proposed by Food and Drug Administration (FDA) or European Food Safety Authority (EFSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Excessive sugar consumption has been related to chronic metabolic problems, including obesity, type 2 diabetes, neuroinflammatory diseases, etc. Therefore, it is recommended to decrease added sugar intake below 10% of total energy intake. Low/no calorie sweeteners (LNCS) may seem as a good alternative to added sugars because they provide sweetness without adding calories to the diet. Although they may reduce energy intake and prevent weight gain, studies investigating the short and long term effects of these sweeteners on metabolic profile are controversial. Therefore, there is a need for future studies to shed light on metabolic effects of these compounds in humans.

Some observational and clinical studies show that they may cause insulin resistance and type 2 diabetes. There are possible mechanisms that may explain this relationship. One of these possible mechanisms is interaction with sweet taste receptors (STRs). It has been shown that STRs not only found in oral cavity but also in extra-oral tissues, such as gastrointestinal tract, pancreas, brain, etc. In vitro studies with sucralose, it has been shown that it may activate STRs in L-cells and stimulate GLP-1 release in a similar manner with glucose. However, these results were not confirmed in vivo.

There are at least six different LNCS approved for human use worldwide. However, each of them have different biological fate in terms of absorption, metabolism and excretion characteristics in the body. Therefore, result of a study with one of LNCS cannot be extrapolated for all LNCS; each of them should be studied in well-designed studies.

In this study it is hypothesized that LNCS may activate STRs in intestinal L-cells and alter release of GLP-1; as a result impair glucose tolerance. In acute human studies, these effects are tested and there are controversial results in regard to glucose tolerance or incretin release. However, individuals who want to consume fewer calories or to better control their blood glucose use LNCS in place of sugar for longer period of time. For this reason, we wanted to test the effects of regular use of LNCS on glucose tolerance and incretin release.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Anadolu
      • Istanbul, Anadolu, Turkey, 34718
        • Acıbadem Dr. Şinasi Can (Kadıköy) Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy,
  • Normoglycemic,
  • Female,
  • 19-45 years old,
  • Weight-stable past 3 months

Exclusion Criteria:

  • Insulin resistance,
  • Type 2 diabetes mellitus,
  • Presence of acute/chronic infection,
  • Use of medication that may affect glucose metabolism (thiazide diuretics, glucocorticoids, estrogen or beta blockers)
  • Chronic alcohol intake,
  • Regular consumption of diet soda (more than one can of soda per week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saccharine Group
140 mg saccharin (Hermesetas) dissolved in 330 mL water for 4 weeks.
Other: Low/No Calorie Sweeteners
LNCS powdered and then dissolved in water.
Active Comparator: Sucralose Group
66 mg sucralose (Splenda) dissolved in 330 mL water for 4 weeks.
Other: Low/No Calorie Sweeteners
LNCS powdered and then dissolved in water.
Active Comparator: Aspartame+Acesulfame-K Group
88 mg aspartame+88 mg acesulfame-K (Takita) dissolved in 330 mL water for 4 weeks.
Other: Low/No Calorie Sweeteners
LNCS powdered and then dissolved in water.
Placebo Comparator: Control Group
330 mL water for 4 weeks.
Other: Placebo Group
Water
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 Hours Plasma Glucose
Time Frame: 3 hours
Change from baseline plasma glucose levels at 4 weeks observed. Participants underwent a 3-h oral glucose tolerance test (3-h OGTT) by consuming a 250 mL 75 g glucose solution, and blood samples were collected at 60, 120, 180 min.
3 hours
3 Hours Plasma Insulin
Time Frame: 3 hours
Change from baseline insulin levels at 4 weeks observed. Participants underwent a 3-h oral glucose tolerance test (3-h OGTT) by consuming a 250 mL 75 g glucose solution, and blood samples were collected at 60, 120, 180 min.
3 hours
Glucagon-like peptide-1 (GLP-1) release
Time Frame: Week 4
Change from baseline fasting GLP-1 levels at 4 weeks observed.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: Week 4
Change from baseline body weight at 4 weeks observed. Participants were weighed on a digital scale (Tanita MC 180) in fasted state. Weights were expressed in kilograms (kg).
Week 4
Fat Mass
Time Frame: Week 4
Change from baseline fat mass (kg) at 4 weeks observed. Fat mass was determined by bioelectrical impedance analysis (BIA) method (Tanita MC180).
Week 4
Fat-Free Mass
Time Frame: Week 4
Change from baseline fat-free mass (kg) at 4 weeks observed. Fat-free mass was determined by bioelectrical impedance analysis (BIA) method (Tanita MC180).
Week 4
Total Body Water
Time Frame: Week 4
Change from baseline total body water (kg) at 4 weeks observed. Total body water was determined by bioelectrical impedance analysis (BIA) method (Tanita MC180).
Week 4
Body Mass Index (BMI)
Time Frame: Week 4
Change from baseline BMI at 4 weeks observed. BMI was calculated as weight (in kilograms) divided by the square of height (in meters).
Week 4
Waist Circumference
Time Frame: Week 4
Change from baseline waist circumference (in centimeters) at 4 weeks observed.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Saziye E Orku, Dr., Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

May 12, 2019

Study Completion (Actual)

July 2, 2019

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 22, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 22, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 28850
  • 218S378 (Other Grant/Funding Number: The Scientific and Technological Research Council of Turkey)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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