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

NCT ID: NCT04492930

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Time Restricted Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Comparator

Time restricted eating

Group Type ACTIVE_COMPARATOR

12:12 Regimen

Intervention Type BEHAVIORAL

12 hours of fasting, followed by a 12-h diet regimen

Intervention

Time restricted eating

Group Type EXPERIMENTAL

14:10 Regimen

Intervention Type BEHAVIORAL

14 hours of fasting, followed by a 10-h diet regimen that includes a fasting snack at 12 hours from the start of the fasting period

Interventions

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14:10 Regimen

14 hours of fasting, followed by a 10-h diet regimen that includes a fasting snack at 12 hours from the start of the fasting period

Intervention Type BEHAVIORAL

12:12 Regimen

12 hours of fasting, followed by a 12-h diet regimen

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Male and female individuals between the age of 18 to 65 years (inclusive) at the time of signing the informed consent
2. Enrollment in the Jenny Craig® Rapid Results™ program
3. Access to a tablet or smartphone with a camera and internet access
4. Body mass index (BMI) at least 30 kg/m2
5. Ability to use a glucometer and Levl device (measures breath acetone)
6. 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.
7. Capable of giving signed informed consent.

Exclusion Criteria

1. Current use of the medications indicated for weight management or treatment of diabetes or for treatment of psychosis
2. 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
3. Serious allergy to milk, soy, wheat, peanuts, or tree nuts that results in throat swelling, rash, hives, or anaphylactic shock
4. Celiac disease
5. Currently being treated with hemodialysis
6. Currently being treated for anorexia/bulimia
7. Require a special diet (vegan, kosher, or halal)
8. Had a baby within the last 6 weeks
9. Are currently breastfeeding
10. Are pregnant
11. Bariatric surgery within the previous 3 years
12. 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jenny Craig, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Peeke, MD

Role: STUDY_DIRECTOR

Jenny Craig, Inc.

Locations

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Jenny Craig

Carlsbad, California, United States

Site Status

Countries

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United States

Other Identifiers

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RRM-102

Identifier Type: -

Identifier Source: org_study_id