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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: glucose; Other: sweetner

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center
  • Kfar-Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Dan Nemet, MD, Meir Medical Center, Kfar-Saba, Israel

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 10, 2012
• First Submitted That Met QC Criteria: September 11, 2012
• First Posted (Estimate): September 12, 2012

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Metabolic syndrome; Overweight; Sugar consumption; Artificially sweetened foods and beverages
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: MeirMc017112CTIL