Artificially Sweetened Beverage Feeding Study | NCT04258345

Studies
Artificially Sweetened Beverage Feeding Study

NCT04258345

Sponsor

Albert Einstein College of Medicine

Status

Withdrawn

Last Update Posted

Apr 24, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cardiovascular Disease

Interventions

ASB Feeding Study

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not yet funded

Expanded Access Info

Start Date

Jul 2021Estimated

Primary Completion Date

Jul 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Feb 4, 2020

First Submission Date that Met QC Criteria

Feb 5, 2020

First Posted Date

Feb 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2020

Last Update Posted Date

Apr 24, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasmin Mossavar-Rahmani, Principal Investigator, Albert Einstein College of MedicinePrincipal Investigator

Lead Sponsor

Albert Einstein College of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of the study are to conduct a pre- and post- two week feeding study of artificial sweetened beverage consumption in middle-aged women. The study will also compare metabolic profiles before and after artificially sweetened beverage consumption.

Detailed Description

The aims of the study are to:

To conduct a pre- and post- two week feeding study of Artificially Sweetened Beverage (ASB) in women.
To assess the general levels of ASB consumption.
To compare metabolic profiles before and after beverage consumption

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Feeding Arm	Other	This is a feeding study.	Other: ASB Feeding Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASB Feeding Study	Other	Participants will undergo a washout period and then scheduled for blood draw after which ASB feeding period will begin followed by a second blood draw.	Active Feeding Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in artificial sweetener levels pre- and post- feeding	Change in metabolites pre- and post-feeding	two weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Healthy women

Exclusion Criteria:

• Having a history of diabetes or cardiovascular disease and any other health or chronic condition that precludes participation in the study.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not at this time.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided