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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01683929
First received: September 10, 2012
Last updated: May 11, 2014
Last verified: May 2014

September 10, 2012
May 11, 2014
May 2013
September 2014   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01683929 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses
The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses and 24 Hour Macronutrient Consumption - A Double Blind, Cross-over Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Obesity
  • 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".

  • 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".

  • 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.
    Intervention: Other: glucose
  • 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.

    Intervention: Other: sweetner
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
January 2015
September 2014   (final data collection date for primary outcome measure)

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).
Both
25 Years to 35 Years
Yes
Contact: Dan Nemet, MD 972-9-7471596 Dan.Nemet@clalit.org.il
Israel
 
NCT01683929
MeirMc017112CTIL
No
Meir Medical Center
Meir Medical Center
Not Provided
Principal Investigator: Dan Nemet, MD Meir Medical Center, Kfar-Saba, Israel
Meir Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP