NCT01683929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 14, 2015

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

September 10, 2012

Last Update Submit

April 13, 2015

Conditions

Obesity

Keywords

ObesityOverweightSugar consumptionMetabolic syndromeArtificially sweetened foods and beverages

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • food questionnaire

    24 hours

Study Arms (2)

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.

Other: glucose

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.

Other: sweetner

Interventions

glucoseOTHER

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".

Oral glucose tolerance test
sweetnerOTHER

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".

Artificial sweetner

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults, healthy, men and women, ages 25-35 years, without any chronic illnesses.

You may not qualify if:

  • Family history of diabetes or overweight with BMI\> 27
  • Use of drugs who can influence the glucose metabolism (exp: glucocorticoids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

ObesityOverweightMetabolic Syndrome

Interventions

Glucose

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Dan Nemet, MD

    Meir Medical Center, Kfar-Saba, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 12, 2012

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

April 14, 2015

Record last verified: 2014-05

Locations

IL(1)