Clinical trial NCT04492930: 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
Overall status: COMPLETED
Phase: NA
Conditions: Time Restricted Feeding
Keywords: body weight
weight loss
ketones
blood glucose
Lead sponsor: Jenny Craig, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in body weight
timeFrame: Week 4
measure: Change in ketone levels (breath acetone)
timeFrame: Week 8
measure: Change in blood glucose
timeFrame: Week 8
Secondary outcomes:
measure: Change in body weight
timeFrame: Week 8
measure: Difference in weight loss between groups
timeFrame: Weeks 4 and 8
measure: Time to first meal
timeFrame: Weeks 4 and 8
Other outcomes:
measure: Correlation between weight loss and change in ketone levels (breath acetone)
timeFrame: Week 8
Locations:
city: Carlsbad
country: United States
facility: Jenny Craig
state: California
Study officials:
affiliation: Jenny Craig, Inc.
name: Pamela Peeke, MD
role: STUDY_DIRECTOR
References: