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

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

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.

Study Overview

• Status: Completed
• Conditions: Time Restricted Feeding
• Intervention / Treatment: Behavioral: 12:12 Regimen; Behavioral: 14:10 Regimen

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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92008
      • Jenny Craig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparator; Time restricted eating	Behavioral: 12:12 Regimen; 12 hours of fasting, followed by a 12-h diet regimen
Experimental: Intervention; Time restricted eating	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Change from baseline body weight in the intervention group	Week 4
Change in ketone levels (breath acetone)	Change from baseline in breath acetone in the intervention group	Week 8
Change in blood glucose	Change from baseline in blood glucose in the intervention group	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Change from baseline body weight in the intervention group	Week 8
Difference in weight loss between groups	Difference in the change from baseline in body weight between the intervention and control groups	Weeks 4 and 8
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	Weeks 4 and 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between weight loss and change in ketone levels (breath acetone)	Correlation between the change from baseline in breath acetone and the change from baseline in body weight	Week 8

Collaborators and Investigators

• Sponsor: Jenny Craig, Inc.
• Investigators: Study Director: Pamela Peeke, MD, Jenny Craig, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: weight loss; blood glucose; body weight; ketones
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: RRM-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No