Time Restricted FeedingNCT04492930
Effect of 14:10 Time-Restricted Eating on Body Weight and Metabolic Markers
A study testing 14:10 Regimen and 12:12 Regimen in people with Time Restricted Feeding, run by Jenny Craig, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Feeding
- What is being tested?
- 14:10 Regimen and 12:12 Regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2020to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Time Restricted Feeding
- Being tested
- 14:10 Regimen, 12:12 Regimen
- Keywords
- body weight, weight loss, ketones, blood glucose
- Medical subject headings
- Intermittent Fasting, Body Weight, Weight Loss, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14:10 RegimenBehavioural
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
12:12 RegimenBehavioural
12 hours of fasting, followed by a 12-h diet regimen
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Time restricted eating Receives: Behavioral: 12:12 Regimen |
| Intervention | Experimental | Time restricted eating Receives: Behavioral: 14:10 Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Change from baseline body weight in the intervention group
Measured: Week 4
Change in ketone levels (breath acetone)
Change from baseline in breath acetone in the intervention group
Measured: Week 8
Change in blood glucose
Change from baseline in blood glucose in the intervention group
Measured: Week 8
Secondary outcomes (3)
Change in body weight
Change from baseline body weight in the intervention group
Measured: Week 8
Difference in weight loss between groups
Difference in the change from baseline in body weight between the intervention and control groups
Measured: 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
Measured: Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start30 Jun 2020
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Time Restricted FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny Craig, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Peeke, MD, Study director, Jenny Craig, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492930
- Sponsor's protocol ID
- RRM-102
- Status last verified
- Nov 2020
- First submitted
- 27 Jul 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Rebello CJ, Zhang D, Anderson JC, Bowman RF, Peeke PM, Greenway FL. Randomized controlled trial of time-restricted eating: secondary analyses of breath acetone. Int J Obes (Lond). 2025 Jul;49(7):1416-1418. doi: 10.1038/s41366-025-01818-1. Epub 2025 Jun 11.
PubMed 40500316
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04492930
- Acronym / sponsor ID
- RRM-102
- Conditions
- Time Restricted Feeding
- Keywords
- body weight, weight loss, ketones, blood glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Jenny Craig, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Behavioral: 12:12 RegimenTime restricted eating |
| Intervention | Experimental | Behavioral: 14:10 RegimenTime restricted eating |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14:10 Regimen14 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 | Behavioural | Intervention |
| 12:12 Regimen12 hours of fasting, followed by a 12-h diet regimen | Behavioural | Comparator |
Primary outcome
Change in body weight
Time frame: Week 4
Change from baseline body weight in the intervention group
Change in ketone levels (breath acetone)
Time frame: Week 8
Change from baseline in breath acetone in the intervention group
Change in blood glucose
Time frame: Week 8
Change from baseline in blood glucose in the intervention group
3 secondary outcomes
Change in body weight
Time frame: Week 8
Difference in weight loss between groups
Time frame: Weeks 4 and 8
Time to first meal
Time frame: Weeks 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 40500316Rebello CJ, Zhang D, Anderson JC, Bowman RF, Peeke PM, Greenway FL. Randomized controlled trial of time-restricted eating: secondary analyses of breath acetone. Int J Obes (Lond). 2025 Jul;49(7):1416-1418. doi: 10.1038/s41366-025-01818-1. Epub 2025 Jun 11.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Time Restricted Feeding
Recruiting
Time Restricted Eating for WeIght LoSs MainTenance-2
Weight Loss, Weight Gain
Recruiting
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Perioperative Care, Intermittent Fasting
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Active, not recruiting
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Prediabetes
Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Obesity (BMI Equal to or >30), Postmenopausal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Peeke, MD study director
Jenny Craig, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14:10 Regimen and 12:12 Regimen in people with Time Restricted Feeding, run by Jenny Craig, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.