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Artificially Sweetened Beverage Feeding Study

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ClinicalTrials.gov Identifier: NCT04258345
Recruitment Status : Withdrawn (not yet funded)
First Posted : February 6, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Yasmin Mossavar-Rahmani, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: ASB Feeding Study Not Applicable

Detailed Description:

The aims of the study are to:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Artificially Sweetened Beverage Feeding Study
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Active Feeding Arm
This is a feeding study.
Other: ASB Feeding Study
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.




Primary Outcome Measures :
  1. Change in artificial sweetener levels pre- and post- feeding [ Time Frame: two weeks ]
    Change in metabolites pre- and post-feeding



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Yasmin Mossavar-Rahmani, Principal Investigator, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT04258345    
Other Study ID Numbers: 2020-11111
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases