Back to results

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

Primary Purpose

Time Restricted Feeding

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

14:10 Regimen

12:12 Regimen

About this trial

This is an interventional treatment trial for Time Restricted Feeding focused on measuring body weight, weight loss, ketones, blood glucose

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Jenny Craig

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Comparator

Intervention

Arm Description

Time restricted eating

Outcomes

Primary Outcome Measures

Change in body weight

Change from baseline body weight in the intervention group

Change in ketone levels (breath acetone)

Change from baseline in breath acetone in the intervention group

Change in blood glucose

Change from baseline in blood glucose in the intervention group

Secondary Outcome Measures

Change in body weight

Change from baseline body weight in the intervention group

Difference in weight loss between groups

Difference in the change from baseline in body weight between the intervention and control groups

Time to first meal

Change from baseline in the length of time from consumption of the fasting snack until initiation of the first meal in the intervention group

Full Information

NCT ID

NCT04492930

First Posted

July 27, 2020

Last Updated

November 3, 2020

Sponsor

Jenny Craig, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04492930

Brief Title

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

Official Title

The Effect of 14:10 Hour Time Restricted Eating on Body Weight and Metabolic Markers: An 8-Week Pilot Study in Individuals With Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

June 30, 2020 (Actual)

Primary Completion Date

October 31, 2020 (Actual)

Study Completion Date

October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jenny Craig, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Time Restricted Feeding

Keywords

body weight, weight loss, ketones, blood glucose

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

Time restricted eating

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Time restricted eating

Intervention Type

Behavioral

Intervention Name(s)

14:10 Regimen

Intervention Description

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

Intervention Name(s)

12:12 Regimen

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in body weight

Description

Change from baseline body weight in the intervention group

Time Frame

Week 4

Title

Change in ketone levels (breath acetone)

Description

Change from baseline in breath acetone in the intervention group

Time Frame

Week 8

Title

Change in blood glucose

Description

Change from baseline in blood glucose in the intervention group

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Change in body weight

Description

Change from baseline body weight in the intervention group

Time Frame

Week 8

Title

Difference in weight loss between groups

Description

Difference in the change from baseline in body weight between the intervention and control groups

Time Frame

Weeks 4 and 8

Title

Time to first meal

Description

Change from baseline in the length of time from consumption of the fasting snack until initiation of the first meal in the intervention group

Time Frame

Weeks 4 and 8

Other Pre-specified Outcome Measures:

Title

Correlation between weight loss and change in ketone levels (breath acetone)

Description

Correlation between the change from baseline in breath acetone and the change from baseline in body weight

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Peeke, MD

Organizational Affiliation

Jenny Craig, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Jenny Craig

City

Carlsbad

State/Province

California

ZIP/Postal Code

92008

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.

IPD Sharing Time Frame

beginning 6 months after publication

IPD Sharing Access Criteria

Upon appropriate data request by other scientists

Learn more about this trial

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

We'll reach out to this number within 24 hrs