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Clinical Trials/NCT01683929
NCT01683929CompletedNot Applicable

The Effects of Oral Glucose Compared to Sweetener Drinking on Hormonal/Metabolic Responses and 24 Hour Macronutrient Consumption - A Double Blind, Cross-over Study

Meir Medical Center2 sites in 1 country12 target enrollmentStarted: May 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
2
Primary Endpoint
Hormonal response

Study Overview

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:

  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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Screening
Masking
Single (Participant)

Eligibility Criteria

Ages
25 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

Artificial sweetner

Placebo Comparator

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: sweetner (Other)

Oral glucose tolerance test

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.

Intervention: glucose (Other)

Outcomes

Primary Outcomes

Hormonal response

Time Frame: 3 hours

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 Outcomes

  • food questionnaire(24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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