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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
glucose
sweetner
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obesity focused on measuring Obesity, Overweight, Sugar consumption, Metabolic syndrome, Artificially sweetened foods and beverages

Eligibility Criteria

25 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Meir Medical Center
  • Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral glucose tolerance test

Artificial sweetner

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hormonal response
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

food questionnaire
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.

Full Information

First Posted
September 10, 2012
Last Updated
April 13, 2015
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01683929
Brief Title
The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses
Official Title
The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses and 24 Hour Macronutrient Consumption - A Double Blind, Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: A beverage containing 75 gram glucose 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Overweight, Sugar consumption, Metabolic syndrome, Artificially sweetened foods and beverages

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral glucose tolerance test
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Artificial sweetner
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
glucose
Intervention Description
The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing 75 gram glucose (oral glucose tolerance test (OGTT / GTT) 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 at 30, 60, 120, 180 minutes after. The participants HR & BP will be monitored throughout the examination + 1 hour after. In addition, the participants will be asked to complete a- "24 hr food questionnaire".
Intervention Type
Other
Intervention Name(s)
sweetner
Intervention Description
The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing artificial sweetened drink. 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 at 30, 60, 120, 180 minutes after. The participants HR & BP will be monitored throughout the examination + 1 hour after. In addition, the participants will be asked to complete a- "24 hr food questionnaire".
Primary Outcome Measure Information:
Title
Hormonal response
Description
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
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
food questionnaire
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Organizational Affiliation
Meir Medical Center, Kfar-Saba, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
Country
Israel

12. IPD Sharing Statement

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

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