The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: glucose; Other: sweetner

• Registration Number: NCT01683929
• Lead Sponsor: Meir Medical Center

Brief Summary

The goal of this study is to determine the hormonal/metabolic reponse to ingestion of sugar compared to consuming artificial sweetened drink, and to evalute macronutrient consumption 24 hours post ingestion of the drinks.

We hypothesize that artificially sweetened (AS) consumption will lead to a relatively similar hormonal/metabolic responses as glucose consumption and therefore to secondary rise of caloric intake.

Detailed Description

During the last two decades, the prevalence of overweight and obesity doubled. at the same time, individuals have increasingly turned to artificially sweetened (AS) foods and beverages in an attempt to lose weight, or control it.

several studies have found that there may be a connection between artificially sweetened food and beverages consumption and paradoxical weight gain and increased incidence of metabolic syndrome. the causal relationship between AS use and weight gain haven't been proven yet.

The participants will be invited to 2 meetings in which they will consume, in a randomized double blind way:

1. A beverage containing 75 gram glucose

2. A beverage containing 0.42 gram artificially sweetener (Aspartame, similar sweetness level)

During each meeting, the participants will drink the sweetened drink followed by blood work, as done in oral glucose challenge or tolerance test (OGTT / GTT).

Also, they will record their macronutrient\\caloric consumption during the 24 hour following the test.

Study Timeline

• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-12
• Study Start: 2013-05
• Status Verified: 2014-05
• Primary Completion: 2014-06
• Study Completion: 2015-01
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Adults, healthy, men and women, ages 25-35 years, without any chronic illnesses.

Exclusion Criteria

• Family history of diabetes or overweight with BMI> 27
• Use of drugs who can influence the glucose metabolism (exp: glucocorticoids).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral glucose tolerance test	glucose	The participants will consume a beverage containing 75 gram glucose During the meeting, the participants will drink the sweetened drink followed by blood work, at 0, 30, 60, 120, 180 minutes. Also, they will record their macronutrient\\caloric consumption during the 24 hour following the test.
Artificial sweetner	sweetner	participants will consume a beverage containing 0.42 gram artificial sweetener (Aspartame) During each meeting, the participants will drink the sweetened drink followed by blood work, at 0, 30, 60, 120, 180 minutes. Also, they will record their macronutrient\\caloric consumption during the 24 hour following the test.

Primary Outcome Measures

Name	Time	Method
Hormonal response	3 hours	All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH- and other related hormones before consuming the drink (time 0), and 30, 60, 120, 180 minutes after.; The participants will be under medical supervision throughout the examination, including HR \& BP montoring, and until 1 hour after

Secondary Outcome Measures

Name	Time	Method
food questionnaire	24 hours	The participants will be receiving a- "24 hr food questionnaire" which they will fill during the day after consuming the drink followed by an interview in order to get the maximal information.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar-Saba, Israel