A Comparison of the Effects of Sugar Sweetened Beverages (SSBs), Diet Beverages and Water on Weight, Body Composition, Liver and Muscle Fat Infiltration, Visceral Fat, Neurocognitive Function, Blood Lipids, Insulin Resistance and Hydration Status in Healthy Weight and Overweight, Premenopausal Females Aged 20-50
Sponsor study identifier
interventional
99
1 country
1
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe purpose of this study is to investigate the effects of consumption of sugar sweetened and diet beverages on overall fat mass and the fat mass of various tissues implicated in the dysregulation of glucose metabolism. In addition, hypothalamic activity will also be investigated after acute exposure to sugar sweetened and diet beverages, and again after 6 months of daily consumption.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 26, 2014
Actual (reported)September 30, 2014
Actual (reported)March 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Fat Storage
Changes in total body adiposity (body fat percentage and fat mass) as measured by Dual X Ray Absorbance after 6 months of daily consumption of sugar sweetened or diet beverages as part of a weight-maintenance structured diet. Changes in fat content of skeletal muscle (via MRI) and liver and the abdomen (both MRS) will also be assessed.
Baseline and 6 Months
Hypothalamic Activity
6 Months
Any beverage from a range of caffeine free, sugar sweetened drinks. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.
Any beverage from a range of caffeine free drinks sweetened with non-caloric sweetener. One serving =12oz. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rippe Lifestyle Institute
Celebration, Florida, 34747, United States
Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
James M Rippe, MD
Rippe Lifestyle Institute
First Submitted
September 26, 2014
First Posted
September 30, 2014
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Estimated (date passed)12 oz of water. Two servings will be consumed daily as part of a structured, weight maintenance diet for 6 months.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 16, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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