Trial Outcomes & Findings for Nutrigenomics: Personalizing Weight Loss for Obese Veterans (NCT NCT01859403)

Last Updated: 2021-04-13

Results Overview

Our primary hypotheses are that more obese veterans in the MOVE! program will lose greater or equal to 5% of their weight if they receive personalized genomic information and a genomically-derived diet built around packaged meals when compared to veterans in the same program that receive usual care during MOVE! and packaged meals after 8 weeks.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information	Personalized Genomics Personalized genomics information from the FIT Test, Pathway Genomics Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
Primary Endpoint Measure STARTED	21	30
Primary Endpoint Measure COMPLETED	20	26
Primary Endpoint Measure NOT COMPLETED	1	4
Secondary Endpoint Measure STARTED	20	26
Secondary Endpoint Measure COMPLETED	14	18
Secondary Endpoint Measure NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information	Personalized Genomics Personalized genomics information from the FIT Test, Pathway Genomics Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
Primary Endpoint Measure Lost to Follow-up	0	2
Primary Endpoint Measure Withdrawal by Subject	1	1
Primary Endpoint Measure Physician Decision	0	1
Secondary Endpoint Measure Withdrawal by Subject	6	8

Baseline Characteristics

Nutrigenomics: Personalizing Weight Loss for Obese Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=20 Participants Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information	Personalized Genomics n=26 Participants Personalized genomics information from the FIT Test, Pathway Genomics Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise	Total n=46 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 12.3 • n=99 Participants	48.4 years STANDARD_DEVIATION 13.1 • n=107 Participants	51.1 years STANDARD_DEVIATION 12.9 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	10 Participants n=107 Participants	13 Participants n=206 Participants
Sex: Female, Male Male	17 Participants n=99 Participants	16 Participants n=107 Participants	33 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	0 Participants n=99 Participants	2 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	5 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants	12 Participants n=107 Participants	25 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	4 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants
Region of Enrollment United States	20 participants n=99 Participants	26 participants n=107 Participants	46 participants n=206 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Usual Care n=20 Participants Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information	Personalized Genomics n=26 Participants Personalized genomics information from the FIT Test, Pathway Genomics Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
Number of Participants With Weight Loss of 5% or More at 8 Weeks	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 24 weeks

We hypothesize that more veterans in the genomic group that lose greater or equal to 5% weight loss at 8 weeks will maintain this weight loss after 24 weeks compared to veterans in the usual care group.

Outcome measures

Outcome measures
Measure	Usual Care n=14 Participants Usual care for veterans as part of the MOVE! program Usual Care: Patients receive the same dietary recommendation regardless of their genetic information	Personalized Genomics n=18 Participants Personalized genomics information from the FIT Test, Pathway Genomics Personalized Genomics: A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
Number of Participants With Weight Loss of 5% or More at 24 Weeks	5 Participants	7 Participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Personalized Genomics

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

Amir Zarrinpar, MD, PhD, Assistant Professor of Gastroenterology

VA San Diego Health Sciences

Phone: 858-246-1665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place