Trial Outcomes & Findings for The DEB Pilot Study (NCT NCT03190993)

NCT ID: NCT03190993

Last Updated: 2020-10-19

Results Overview

Change from baseline in body weight at 1 month

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

1 month

Results posted on

2020-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Sugar Sweetened Solid Treatment A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.	Sugar Sweetened Beverage Treatment 20 oz. carbonated sugar sweetened beverage. Added ingredients include: \~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The DEB Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Sweetened Solid Treatment n=10 Participants A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.	Sugar Sweetened Beverage Treatment n=10 Participants 20 oz. carbonated sugar sweetened beverage. Added ingredients include: \~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.	Total n=20 Participants Total of all reporting groups
Age, Continuous	36 years n=99 Participants	39 years n=107 Participants	37 years n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants	8 Participants n=107 Participants	14 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 1 month

Change from baseline in body weight at 1 month

Outcome measures

Outcome measures
Measure	Sugar Sweetened Solid Treatment n=10 Participants A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. Sugar Sweetened Solid Treatment: Consume Sugar Sweetened Solid Treatment (product) daily.	Sugar Sweetened Beverage Treatment n=10 Participants 20 oz. carbonated sugar sweetened beverage. Added ingredients include: \~2.1g whey protein powder. Sugar Sweetened Beverage Treatment: Consume Sugar Sweetened Beverage Treatment (product) daily.
Change From Baseline in Body Weight	-0.325 kg Standard Error 0.307	0.230 kg Standard Error 0.307

Adverse Events

Sugar Sweetened Solid Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Sweetened Beverage Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Apolzan

Pennington Biomedical Research Center

Phone: 225-763-2827

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place