Artificially Sweetened Beverage Feeding Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Other: ASB Feeding Study

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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2020-11111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No