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

NCT04492930 | Completed

• 1 other identifier: RRM-102
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Time Restricted Feeding

Keywords

body weight; weight loss; ketones; blood glucose

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in body weight

  Week 8

• Difference in weight loss between groups

  Weeks 4 and 8

• Time to first meal

  Weeks 4 and 8

Other Outcomes (1)

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

  Week 8

Study Arms (2)

Comparator

ACTIVE COMPARATOR

Time restricted eating

Behavioral: 12:12 Regimen

Intervention

EXPERIMENTAL

Time restricted eating

Behavioral: 14:10 Regimen

Interventions

14:10 Regimen 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

Intervention

12:12 Regimen BEHAVIORAL

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

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jenny Craig, Inc.: lead

Study Sites (1)

Jenny Craig

Carlsbad, California, 92008, United States

Location

MeSH Terms

Conditions

Intermittent Fasting; Body Weight; Weight Loss; Ketosis

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Pamela Peeke, MD

  Jenny Craig, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: June 30, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning 6 months after publication
• Access Criteria: Upon appropriate data request by other scientists

Locations

US (1)