Completed

Effects of Glucose and Artificial Sweetener on Hormonal/Metabolic Responses and Macronutrient Consumption

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Study Aim

This study aims to observe how your body responds to glucose and artificial sweetener by measuring various hormonal and metabolic reactions at different time intervals after consuming a drink.

What is being tested

Glucose Test for Hormone Levels

+ Effects of Artificial Sweetener on Hormones

Other
Who is being recruted

Body Weight+10

+ Hyperinsulinism

+ Insulin Resistance

From 25 to 35 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Screening Study

Placebo-Controlled
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorMeir Medical Center
Last updated: April 14, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorMeir Medical Center
Last updated: April 14, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightHyperinsulinismInsulin ResistanceMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersObesityMetabolic SyndromeOverweight

Criteria

1 inclusion criteria required to participate
Adults, healthy, men and women, ages 25-35 years, without any chronic illnesses

2 exclusion criteria prevent from participating
Family history of diabetes or overweight with BMI > 27

Use of drugs who can influence the glucose metabolism (exp: glucocorticoids)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
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.

Group II

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Meir Medical Center

Kfar Saba, IsraelOpen Meir Medical Center in Google Maps
CompletedOne Study Center