NCT01200940

Brief Summary

Background: \- Artificial sweeteners, such as sucralose (brand name Splenda), are very commonly found in products such as diet soft drinks. Recently, researchers learned that these sweeteners may affect hormones in the body, especially when they are consumed in combination with real sugar. Changes in hormone levels may, in turn, result in changes in blood sugar, appetite, and weight. Researchers are interested in studying the effects of artificial sweeteners on the metabolism and hormonal levels of healthy volunteers. Objectives:

  • To study the effects that artificial sweeteners have on hormone levels, blood sugar, and appetite.
  • To evaluate whether artificial sweeteners change the rate at which food passes out of the stomach into the gut, or the rate at which the body absorbs sugar from the gut.
  • To evaluate the effects that different amounts of artificial sweeteners have on hormone levels. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design:
  • This study will require one screening visit and four testing visits, scheduled on different days.
  • At the screening visit, eligible participants will be screened with a physical examination, medical history, blood samples, and body measurements (including height, weight, body circumferences, and skin folds). Participants will also be asked about how much artificial sweetener they typically consume and will have taste tests, in which a small amount of flavored liquid is placed on the tongue and participants will name the flavor and rate its intensity.
  • Participants will have four glucose tolerance tests on four different days. In preparation for the test, participants will not eat or drink anything but water for 12 hours prior to the test. Blood will be drawn before the test, and participants will drink one of the following study liquids, selected at random:
  • Plain water
  • Water mixed with sucralose (the amount found in one 12 oz diet soft drink)
  • Water mixed with sucralose (the amount found in 2.5 12 oz diet soft drinks)
  • Water mixed with sucralose (the amount found in 3.7 12 oz diet soft drinks)
  • Ten minutes after drinking the study liquid, participants will have a sugary drink that will allow researchers to measure sugar absorption and the speed with which food leaves the stomach.
  • In addition, participants will complete questionnaires about hunger levels before drinking the sugar solution and at regular intervals for 2 hours afterward. Blood samples will be taken at regular intervals as well.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1 healthy-volunteers

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

First Submitted

Initial submission to the registry

September 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 4, 2010

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

6.3 years

First QC Date

September 11, 2010

Last Update Submit

January 21, 2021

Conditions

Healthy Volunteers

Keywords

GLP-1Glucose ToleranceGut Hormones

Outcome Measures

Primary Outcomes (1)

  • GLP-1 secretion change with sucralose

    After a 10-hour fast, subjects will drink a 75-gram oral glucose solution. Samples will be drawn at -10, 0, 10, 20, 30, 60, 90, and 120 minutes.

    At minute -10,0,10, 20,30,60,90,120

Secondary Outcomes (2)

  • Change in gastric emptying

    At minute -10,0,10, 20,30,60,90,120

  • Change in satiety

    At minute -10,0,10, 20,30,60,90,120

Study Arms (8)

Phase I - Low-dose sweetener

EXPERIMENTAL

68 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Other: Sucralose

Phase I - Medium-dose sweetener

EXPERIMENTAL

170 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Other: Sucralose

Phase I Control Condition

PLACEBO COMPARATOR

360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Other: Control

Phase I- High-dose sweetener

EXPERIMENTAL

250 mg sucralose dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test.

Other: Sucralose

Phase II - Control Condition

PLACEBO COMPARATOR

360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Other: Control

Phase II - Diet Soda 1

EXPERIMENTAL

less than or equal to 5mg/kg sucralose, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Other: SucraloseOther: Acesulfame-Potassium

Phase II - Diet Soda 2

EXPERIMENTAL

less than or equal to 5 mg/kg sucralose, less than or equal to 50 mg/kg aspartame, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Other: SucraloseOther: AspartameOther: Acesulfame-Potassium

Phase II - Water with sucralose and acesulfame-potassium

EXPERIMENTAL

less than or equal to 5mg/kg sucralose, less than or equal to 15 mg/kg acesulfame-potassium dissolved in 360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Other: SucraloseOther: Acesulfame-Potassium

Interventions

SucraloseOTHER

sucralose will be given at doses of 68 mg (equivalent to one 12 oz soda) 170 mg (equivalent to two and one-half 12 oz sodas, and 250 mg (equal to 100% of the FDA s acceptable daily intake for a 50kg individual).

Phase I - Low-dose sweetenerPhase I - Medium-dose sweetenerPhase I- High-dose sweetenerPhase II - Diet Soda 1Phase II - Diet Soda 2Phase II - Water with sucralose and acesulfame-potassium
AspartameOTHER

To determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola .

Phase II - Diet Soda 2
Acesulfame-PotassiumOTHER

To determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola .

Phase II - Diet Soda 1Phase II - Diet Soda 2Phase II - Water with sucralose and acesulfame-potassium
ControlOTHER

360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test

Phase I Control ConditionPhase II - Control Condition

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years
  • No known active medical conditions

You may not qualify if:

  • Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications, vitamins, and hormonal contraceptives. Other medications may be permitted at the discretion of the investigators.
  • Recent (past 2 months) use of drugs that alter glucose metabolism (e.g. metformin), alter gastric pH (e.g. proton pump inhibitors) or gastric emptying (e.g. metoclopramide)
  • ALT or AST more than 1.5 times the upper limit of normal
  • Positive urine pregnancy test
  • Known allergy, sensitivity or other contraindication to any study food or drug or its vehicle
  • Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures
  • Body weight less than 50 kg
  • Diabetes (fasting blood glucose of 126 mg/dl or higher, or 2-hour blood glucose of 200 or higher on oral glucose tolerance testing)
  • Glycosuria
  • PEDIATRIC PILOT STUDY:
  • Age 6-12 years at enrollment
  • Body weight at least 17 kg
  • Prepubertal (Tanner stage I breasts in girls, or testicular volumes less than or equal to 3 mL in boys)
  • No known active medical conditions
  • Current use of prescription or non-prescription medication. Certain exceptions are permitted, including topical medications and vitamins. Other medications may be permitted at the discretion of the investigators.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Sylvetsky AC, Brown RJ, Blau JE, Walter M, Rother KI. Hormonal responses to non-nutritive sweeteners in water and diet soda. Nutr Metab (Lond). 2016 Oct 21;13:71. doi: 10.1186/s12986-016-0129-3. eCollection 2016.

    PMID: 27777606DERIVED

Related Links

MeSH Terms

Interventions

trichlorosucroseAspartameacetosulfame

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Rebecca J Brown, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2010

First Posted

September 14, 2010

Study Start

November 4, 2010

Primary Completion

March 2, 2017

Study Completion

March 30, 2017

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

US(1)