ObesityNCT03571048
Pilot Study of Time Restricted Feeding as a Weight Loss Intervention
A study testing Reduced Calorie Diet (RCD) and Time Restricted Feeding (TRF) in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The circadian timing of Energy Intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating later in the evening or at night when the circadian system is promoting sleep adversely influences weight loss. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Reduced Calorie Diet (RCD) and Time Restricted Feeding (TRF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 12 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males and females with a BMI of 27-45 kg/m2 and weight stable over the previous 6 months;
- Age, 18-50 years old;
- Passing medical and physical screening, and analysis of blood and urine screening samples;
- Typical eating duration >12 hours per day (assessed by questionnaires);
- Own a smartphone
Who cannot join
- Pregnancy or lactation for women (women who are >6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months)
- Postmenopausal women (menopausal status will be assessed during the history and physical, with requirement of self-reported regular menstrual cycles for the last year; women who have undergone hysterectomy but with ovaries in place who continue to have regular menstrual symptoms can be included)
- Being considered unsafe to participate as determined by the study physician;
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
- History of human immunodeficiency virus or hepatitis B or C (self-report);
- Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
Show all 13Show fewer
- Having abnormal blood chemistry (eGFR<45mL/min, AST or ALT >3 times the upper limit of normal) or as deemed significant by the study physician;
- Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- Working night shifts;
- Extreme early or extreme late chronotype as determined by the Munich Chronotype questionnaire37;
- Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week) as assessed with meal pattern assessment questionnaire;
- For participants completing the PSG studies, greater than moderate sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire). Participants completing the primary weight loss intervention will not be excluded based on Berlin OSA risk scores.
- For participants completing the PSG studies, use of medications affecting sleep (benzodiazepines and other sleep aids, as determined by study physician). Participants completing the primary weight loss intervention will not be excluded based on use of medications affecting sleep.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Health and Wellness Center
Aurora, Colorado, 80045
About this study
Official title: Pilot Study of Time Restricted Feeding as a Weight Loss Intervention in Overweight and Obese Adults
The circadian timing of Energy Intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating later in the evening or at night when the circadian system is promoting sleep adversely influences weight loss. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful weight loss strategy. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators aims are to: 1) Assess processes critical for the success of a large-scale trial comparing the efficacy of a reduced calorie diet with time restricted feeding (RCD+TRF) versus standard RCD on weight loss; 2) Develop methodology to assess compliance to the RCD+TRF versus standard RCD program and collect preliminary data on whether the programs have differential effects on free-living behaviors (EI, appetite, physical activity, and sedentary behavior); and 3) Measure metabolic responses to RCD+TRF versus standard RCD to determine candidate mechanisms related to weight loss at 12wks and weight maintenance at 6mo post-intervention. The investigators primary hypothesis is that weight loss will be greater in the TRF group compared to the RCD group.
Read the detailed description
The circadian timing of energy intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating meals later in the evening or during the biological night when the circadian system is promoting sleep adversely influences the success of weight loss therapy. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful strategy for promoting weight loss and weight maintenance. However, potential benefits of adding TRF to a weight loss program have yet to be evaluated in a well-controlled clinical study. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators overall hypothesis is that feasibility, adherence, and acceptability of a weight loss intervention using TRF in the setting of a reduced calorie diet (RCD) - RCD+TRF - will be similar to compliance with an intervention using a reduced calorie diet alone (RCD), suggesting acceptability for a future large-scale trial. In this 12-week pilot and feasibility study, 30 overweight and obese individuals will be randomized 1:1 to RCD+TRF (EI restricted to a 10-hour window starting 1 hour from habitual waking time) or standard RCD (no restriction on feeding duration). Additional follow-up will occur at 6 months to collect pilot data on weight maintenance. Measures include feasibility, acceptability and adherence to the interventions, body weight, body composition (Dual-energy X-ray absorptiometry (DXA)), EI (smart phone application), physical activity (PA, accelerometery), glucose variability (continuous glucose monitoring, CGM), sleep (questionnaires and polysomnography), and nocturnal substrate metabolism (room calorimetry). The specific aims (SA) are as follows:
Specific Aim 1a. To evaluate the feasibility and acceptability of a 12-week TRF intervention compared to a standard dietary weight loss intervention (i.e. RCD). Feasibility of enrollment and retention, and acceptability of the intervention will be assessed in adults with obesity meeting inclusion/exclusion criteria proposed for the future large-scale trial. The investigators will assess adherence to the weight loss programs, as measured objectively with a novel smartphone application and verified with CGM data, and subjectively with the use of questionnaires.
Specific Aim 1b. To assess the efficacy of RCD+TRF compared to RCD alone in producing weight loss at 12 weeks and reducing the risk of weight regain after 6 months of follow-up.
- Conditions
- Obesity
- Being tested
- Reduced Calorie Diet (RCD), Time Restricted Feeding (TRF)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Calorie Diet (RCD)Behavioural
Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
Time Restricted Feeding (TRF)Behavioural
Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Calorie Diet (RCD) | Active comparator | Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy. Receives: Behavioral: Reduced Calorie Diet (RCD) |
| Time Restricted Feeding (TRF) | Experimental | Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy. Receives: Behavioral: Reduced Calorie Diet (RCD); Behavioral: Time Restricted Feeding (TRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Weight
Body weight will be measured via clinic scale.
Measured: Baseline, 12 weeks
Secondary outcomes (4)
Changes in Fat Mass
Body composition will be assessed with dual-energy x-ray absorptiometry (DXA).
Measured: Baseline, 12 weeks
Changes in Objectively Measured Energy Intake (Camera)
All energy intake events will be recorded using the camera function on a cell phone application
Measured: Baseline, 12 weeks
Changes in Physical Activity
Step count will be measured with activity monitors.
Measured: Baseline, 12 weeks
Changes in Sedentary Behavior
Sitting time will be measured with activity monitors.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Jun 2018
- Primary completion14 May 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Thomas, MD, Principal investigator, University of Colorado Anschutz Health and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571048
- Sponsor's protocol ID
- 18-0487
- Other IDs
- R21DK117499-02
- Status last verified
- Oct 2022
- First submitted
- 31 May 2018
- Last updated
- 25 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas EA, Zaman A, Sloggett KJ, Steinke S, Grau L, Catenacci VA, Cornier MA, Rynders CA. Early time-restricted eating compared with daily caloric restriction: A randomized trial in adults with obesity. Obesity (Silver Spring). 2022 May;30(5):1027-1038. doi: 10.1002/oby.23420.
PubMed 35470974Zaman A, Sloggett KJ, Caldwell AE, Catenacci VA, Cornier MA, Grau L, Vetter C, Rynders CA, Thomas EA. The effects of the COVID-19 pandemic on weight loss in participants in a behavioral weight-loss intervention. Obesity (Silver Spring). 2022 May;30(5):1015-1026. doi: 10.1002/oby.23399. Epub 2022 Apr 12.
PubMed 35118814
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Time Restricted Feeding as a Weight Loss Intervention in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT03571048
- Acronym / sponsor ID
- 18-0487
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Posted 25 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The circadian timing of Energy Intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating later in the evening or at night when the circadian system is promoting sleep adversely influences weight loss. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful weight loss strategy. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators aims are to: 1) Assess processes critical for the success of a large-scale trial comparing the efficacy of a reduced calorie diet with time restricted feeding (RCD+TRF) versus standard RCD on weight loss; 2) Develop methodology to assess compliance to the RCD+TRF versus standard RCD program and collect preliminary data on whether the programs have differential effects on free-living behaviors (EI, appetite, physical activity, and sedentary behavior); and 3) Measure metabolic responses to RCD+TRF versus standard RCD to determine candidate mechanisms related to weight loss at 12wks and weight maintenance at 6mo post-intervention. The investigators primary hypothesis is that weight loss will be greater in the TRF group compared to the RCD group.
Detailed description
The circadian timing of energy intake (EI) has emerged as a key factor in the regulation of body weight. Studies have suggested that eating meals later in the evening or during the biological night when the circadian system is promoting sleep adversely influences the success of weight loss therapy. In contrast, restricting EI to a short window during waking hours and extending the length of the overnight fast (i.e., time restricted feeding, TRF) may be a practical and useful strategy for promoting weight loss and weight maintenance. However, potential benefits of adding TRF to a weight loss program have yet to be evaluated in a well-controlled clinical study. The overall objective of this proposal is to provide a foundation to inform the design of a future large-scale trial to evaluate the efficacy of TRF in generating weight loss. The investigators overall hypothesis is that feasibility, adherence, and acceptability of a weight loss intervention using TRF in the setting of a reduced calorie diet (RCD) - RCD+TRF - will be similar to compliance with an intervention using a reduced calorie diet alone (RCD), suggesting acceptability for a future large-scale trial. In this 12-week pilot and feasibility study, 30 overweight and obese individuals will be randomized 1:1 to RCD+TRF (EI restricted to a 10-hour window starting 1 hour from habitual waking time) or standard RCD (no restriction on feeding duration). Additional follow-up will occur at 6 months to collect pilot data on weight maintenance. Measures include feasibility, acceptability and adherence to the interventions, body weight, body composition (Dual-energy X-ray absorptiometry (DXA)), EI (smart phone application), physical activity (PA, accelerometery), glucose variability (continuous glucose monitoring, CGM), sleep (questionnaires and polysomnography), and nocturnal substrate metabolism (room calorimetry). The specific aims (SA) are as follows:
Specific Aim 1a. To evaluate the feasibility and acceptability of a 12-week TRF intervention compared to a standard dietary weight loss intervention (i.e. RCD). Feasibility of enrollment and retention, and acceptability of the intervention will be assessed in adults with obesity meeting inclusion/exclusion criteria proposed for the future large-scale trial. The investigators will assess adherence to the weight loss programs, as measured objectively with a novel smartphone application and verified with CGM data, and subjectively with the use of questionnaires.
Specific Aim 1b. To assess the efficacy of RCD+TRF compared to RCD alone in producing weight loss at 12 weeks and reducing the risk of weight regain after 6 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Calorie Diet (RCD) | Active comparator | Behavioral: Reduced Calorie Diet (RCD)Participants in this group will focus on daily calorie restriction as their dietary weight loss strategy. |
| Time Restricted Feeding (TRF) | Experimental | Behavioral: Reduced Calorie Diet (RCD), Behavioral: Time Restricted Feeding (TRF)Participants in this group will focus on time restricted feeding in addition to daily calorie restriction as their dietary weight loss strategy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult males and females with a BMI of 27-45 kg/m2 and weight stable over the previous 6 months;
- Age, 18-50 years old;
- Passing medical and physical screening, and analysis of blood and urine screening samples;
- Typical eating duration >12 hours per day (assessed by questionnaires);
- Own a smartphone
Key exclusion criteria (13 listed)
- Pregnancy or lactation for women (women who are >6 months postpartum with no plans of becoming pregnant in the next year and who are not currently lactating can be included; oral contraceptives will be allowed if medication has been consistent for the prior 6 months)
- Postmenopausal women (menopausal status will be assessed during the history and physical, with requirement of self-reported regular menstrual cycles for the last year; women who have undergone hysterectomy but with ovaries in place who continue to have regular menstrual symptoms can be included)
- Being considered unsafe to participate as determined by the study physician;
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
- History of human immunodeficiency virus or hepatitis B or C (self-report);
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 |
|---|---|---|
| Reduced Calorie Diet (RCD)Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. | Behavioural | Reduced Calorie Diet (RCD), Time Restricted Feeding (TRF) |
| Time Restricted Feeding (TRF)Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows. | Behavioural | Time Restricted Feeding (TRF) |
Primary outcome
Changes in Body Weight
Time frame: Baseline, 12 weeks
Body weight will be measured via clinic scale.
4 secondary outcomes
Changes in Fat Mass
Time frame: Baseline, 12 weeks
Changes in Objectively Measured Energy Intake (Camera)
Time frame: Baseline, 12 weeks
Changes in Physical Activity
Time frame: Baseline, 12 weeks
Changes in Sedentary Behavior
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35470974Thomas EA, Zaman A, Sloggett KJ, Steinke S, Grau L, Catenacci VA, Cornier MA, Rynders CA. Early time-restricted eating compared with daily caloric restriction: A randomized trial in adults with obesity. Obesity (Silver Spring). 2022 May;30(5):1027-1038. doi: 10.1002/oby.23420.
- Derived from this study: PubMed 35118814Zaman A, Sloggett KJ, Caldwell AE, Catenacci VA, Cornier MA, Grau L, Vetter C, Rynders CA, Thomas EA. The effects of the COVID-19 pandemic on weight loss in participants in a behavioral weight-loss intervention. Obesity (Silver Spring). 2022 May;30(5):1015-1026. doi: 10.1002/oby.23399. Epub 2022 Apr 12.
- Individual participant dataSharing planned: No
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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.
Elizabeth Thomas, MD principal investigator
University of Colorado Anschutz Health and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Calorie Diet (RCD) and Time Restricted Feeding (TRF) in people with Obesity, run by University of Colorado, Denver 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 5 inclusion and 13 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 25 Oct 2022. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Body Weight (time frame: Baseline, 12 weeks). 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 NCT03571048, which also lists 2 linked publications.
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 25 Oct 2022.