Effect of 14:10 Time-Restricted Eating on Body Weight and Metabolic Markers

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Jenny Craig, Inc.
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Updated on 16 February 2024
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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.

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 fasting) and a period of nourishing. Providing the body a period of regeneration allows the body to go into ketosis, or the elevation in circulating ketone bodies, a byproduct of fat metabolism. Breath acetone concentration is a good predictor of ketosis and loss of body fat. In healthy individuals, low concentrations of breath acetone are 1 to 2 ppm. Engaging in weight loss via nutritional ketosis (engaging in high-fat, low-carbohydrate diets, caloric restriction diets, or fasting) increases fat utilization, resulting in increased formation of ketone bodies and breath acetone concentrations ranging from 4 to 30 ppm. In individuals with obesity, nutritional ketosis facilitates weight loss and improves insulin sensitivity, lipid profile, and reduces inflammatory markers.

This study will investigate the effect of participating in two different time restricted eating schedules for 8 weeks on body weight, blood glucose, and ketones.

After being informed about the study and potential risks, all eligible participants giving written informed consent will be randomized to a different time restricted eating schedule (ie, one group fasts for a longer period of time). In both of these groups, fasting will begin each evening and end the following morning.

This is a remote study. All procedures will be conducted at home.

Details
Condition Time Restricted Feeding
Age 18years - 65years
Treatment 14:10 Regimen, 12:12 Regimen
Clinical Study IdentifierNCT04492930
SponsorJenny Craig, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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