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

This study is currently recruiting participants.
Verified October 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01683929
First received: September 10, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Obesity
Other: glucose
Other: sweetner

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Hormonal response [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral glucose tolerance test
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.
Other: glucose

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".

Placebo Comparator: Artificial 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.

Other: sweetner

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".


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.

  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683929

Contacts
Contact: Dan Nemet, MD 972-9-7471596 Dan.Nemet@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Dan Nemet, MD    972-9-7471596    Dan.Nemet@clalit.org.il   
Principal Investigator: Dan Nemet, MD         
Meir Medical Center Not yet recruiting
Kfar-Saba, Israel
Contact: Dan Nemet, MD    972-9-7471596    Dan.Nemet@clalit.org.il   
Principal Investigator: Dan Nemet, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Dan Nemet, MD Meir Medical Center, Kfar-Saba, Israel
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01683929     History of Changes
Other Study ID Numbers: MeirMc017112CTIL
Study First Received: September 10, 2012
Last Updated: October 24, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
Obesity
Overweight
Sugar consumption
Metabolic syndrome
Artificially sweetened foods and beverages

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014