Status:
COMPLETED
Effect of 14:10 Time-Restricted Eating on Body Weight and Metabolic Markers
Lead Sponsor:
Jenny Craig, Inc.
Conditions:
Time Restricted Feeding
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the effect of engaging in time restricted eating schedule on body weight, blood glucose, and ketones (breath acetone) in individuals with obesity.
Detailed Description
There are significant metabolic and weight reduction benefits associated with time restricted feeding/eating. Time restricted eating splits the day into a period of regeneration (non-eating or natural...
Eligibility Criteria
Inclusion
- Male and female individuals between the age of 18 to 65 years (inclusive) at the time of signing the informed consent
- Enrollment in the Jenny Craig® Rapid Results™ program
- Access to a tablet or smartphone with a camera and internet access
- Body mass index (BMI) at least 30 kg/m2
- Ability to use a glucometer and Levl device (measures breath acetone)
- Female participants of childbearing potential will agree to avoid pregnancy during the study. Medically acceptable methods of contraception include oral contraceptive medication, an intrauterine device (IUD), an implantable contraceptive (such as Implanon), an injectable contraceptive (such as Depo-Provera), a barrier method (such as condom or diaphragm with spermicide), abstinence, or having exclusive sexual relations with a vasectomized or same sex partner.
- Capable of giving signed informed consent.
Exclusion
- Current use of the medications indicated for weight management or treatment of diabetes or for treatment of psychosis
- Serious allergy to corn, corn products, or gluten (due to the number of Jenny's Cuisine® items that contain these food ingredients) that results in throat swelling, rash, hives, or anaphylactic shock
- Serious allergy to milk, soy, wheat, peanuts, or tree nuts that results in throat swelling, rash, hives, or anaphylactic shock
- Celiac disease
- Currently being treated with hemodialysis
- Currently being treated for anorexia/bulimia
- Require a special diet (vegan, kosher, or halal)
- Had a baby within the last 6 weeks
- Are currently breastfeeding
- Are pregnant
- Bariatric surgery within the previous 3 years
- Individuals belonging to the following vulnerable populations (people with disabilities, people who cannot read, educationally disadvantaged, individuals with a serious or life threatening illness, prisoners, non-English speakers, economically disadvantaged individuals, employees of the study sponsor)
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT04492930
Start Date
June 30 2020
End Date
October 31 2020
Last Update
November 5 2020
Active Locations (1)
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1
Jenny Craig
Carlsbad, California, United States, 92008