Metabolic Effects of Non-nutritive Sweeteners

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02413424

Acronym

NNS

Enrollment

Registered

2015-04-09

Start date

2015-04-30

Completion date

2017-07-31

Last updated

2017-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

sucralose

Brief summary

The purpose of this research study is to examine whether sugar-replacement sweeteners that are currently on the market (ex. Sucralose, which is in Splenda) change how well the body works to control blood sugar.

Detailed description

The investigators of this study have recently found that sucralose, the most commonly used non-nutritive sweetener (NNS), affects the glycemic response to an oral glucose tolerance test (OGTT) and potentiates glucose-stimulated insulin secretion in obese people who are not regular consumers of NNS. However, studies conducted in healthy lean adults, none of which control for previous use of NNS, show that sucralose does not affect glycemic or hormonal responses to the ingestion of glucose or other carbohydrates. Therefore, we do not know a) whether sucralose effects are limited to obese subjects, or are generalizable to lean people when controlling for prior history of NNS consumption, and b) mechanism(s) responsible for the acute effect of sucralose on glucose metabolism as we measured in obese subjects. The aim of this study is to determine the effects of an acute intake of sucralose on the metabolic response to an oral glucose tolerance test in lean and obese people.

Interventions

DIETARY_SUPPLEMENTSucralose

60 ml of 2mM sucralose

OTHERWater

60 ml of water

DIETARY_SUPPLEMENTglucose load

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI ≥ 30 kg/m2 or BMI ≥ 18 kg/m2 and BMI\<25 kg/m2 * insulin sensitive: based on the homeostasis model assessment of insulin resistance (HOMA-IR) \<3

Exclusion criteria

* BMI ≥ 25 kg/m2 and BMI\<30 kg/m2 * HOMA-IR\>3 * Current smoker or quit smoking less than 6 months ago * pregnancy or breastfeeding * subjects who have malabsorptive syndromes, phenylketonuria, inflammatory intestinal disease, liver or kidney diseases, diabetes * subjects who are taking any medication that might affect metabolism * anemia * regular use of non-nutritive sweeteners

Design outcomes

Primary

Measure	Time frame	Description
Peak insulin secretion rate	up to 5 hours after drinking a glucose load	Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma insulin and C-peptide. Insulin secretion rate will be assessed using the minimal model of Breda and collaborators.
Glucose rate of appearance	up to 5 hours after drinking a glucose load	Blood samples will be collected before and for 5 hours after drinking a glucose load to determine glucose and glucose tracer:tracee ratios.

Secondary

Measure	Time frame	Description
Glucose-dependent insulinotropic polypeptide (GIP)	up to 5 hours after drinking a glucose load	Blood samples will be collected before and for 5 hours after drinking a glucose load to determine GIP.
Sucralose concentrations in plasma	up to 310 min after drinking the sucralose load	Sucralose concentrations in plasma will be measured by using liquid chromatography-mass spectrometry.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026