Metabolic Effects of Non-Nutritive Sweeteners

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.

Conditions

• Healthy Volunteers

Interventions

OTHER

Sucralose

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).

OTHER

Aspartame

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 .

OTHER

Acesulfame-Potassium

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 .

OTHER

Control

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

Sponsors & Collaborators

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

  lead NIH

Principal Investigators

• Rebecca J Brown, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-04

Primary Completion

2017-03-02

Completion

2017-03-30

Countries

• United States

Study Locations