ObesityTRIONCT04884659
Time-Restricted Feeding
A study testing Time restricted feeding arm and usual feeding pattern arm in people with Obesity and Inflammatory Markers, run by Rockefeller University at 1 site in United States.
Trial summary
We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with prediabetes and obesity. We will study the effect of restricting the timing of caloric intake to earlier in the day (TRF) versus later in the day (usual feeding pattern, UFP) on glycemia and inflammation in an inpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Inflammatory Markers, Glycemic Variation
- What is being tested?
- Time restricted feeding arm and usual feeding pattern arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 15 Aug 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >25 kg/m2
- If taking probiotics during screening, must agree to continue taking them at the same dosage and frequency
- HbA1C 5.7-6.4%
- Willing to eat only the food provided
- Willing to follow the feeding schedule, including fasting for 14 hours/day for 7 days
- Willing to remain on the RU inpatient 24/7 unit except for weekend passes
- Normally sleep between the hours of 10 pm and 8 am
- Weight stable over the last 3 months defined as no more than a 5% change
Who cannot join
- Diabetes
- Any intermittent feeding diet within the last 2 weeks
- HIV positive
- Hepatitis
- Self-reported autoimmune diseases (rheumatoid arthritis, SLE (lupus), Crohn's
- Disease, psoriasis, etc.)
Show all 14Show fewer
- Current use of metformin
- Smoked tobacco within the last 8 weeks
- Taking any weight loss medication
- Current use of systemic steroids
- Allergic to adhesive tape
- Taking clinically useful medications that contribute to significant weight loss or weight gain ie tricyclic antidepressants, some SSRIs, lithium, antipsychotics, some anticonvulsants, steroids, beta blockers, some antihistamines.
- Currently pregnant
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University Hospital
New York, New York, 10065
About this study
Official title: The Impact of Time-Restricted Feeding on Metabolism and Inflammation in Obesity (TRIO Study)
We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with prediabetes and obesity. We will study the effect of restricting the timing of caloric intake to earlier in the day (TRF) versus later in the day (usual feeding pattern, UFP) on glycemia and inflammation in an inpatient setting.
Read the detailed description
Time Restricted Feeding (TRF) is a variant of intermittent fasting that confines caloric intake to active daytime hours and involves fasting for 12 to 14 hours. Circadian misalignment caused by changes in sleeping and eating behaviors has emerged as having a detrimental impact on weight, glucose homeostasis and other cardiovascular disease-related outcomes. Feeding during active periods appears to be advantageous for weight, glucose metabolism and lipid profiles whereas feeding during the inactive period confers deleterious effects on these outcomes. Therefore, TRF shows great promise as a novel intervention for addressing obesity and related cardiovascular outcomes.
Animal studies suggest that timing of feeding, including intermittent fasting or TRF, decreases inflammation and causes ketosis. Human studies that examined time restricted feeding for improvement in glycemia in as little as 4 days did not observe changes in clinical markers of inflammarion such as hsCRP. Moreover, systemic and adipose tissue inflammation as it occurs in obesity shows dynamic changes in the context of weight loss that would not be clearly apparent in a weight stable state. A potential mechanistic link between glycemic improvement and systemic inflammation would be the Receptor for Advanced Glycation End-Products (RAGE) and its soluble form (sRAGE).This form of inflammation has not been measured in reported eTRF studies and its relationship with eTRFwould bea significant contribution from the proposed study.
- Being tested
- Time restricted feeding arm, usual feeding pattern arm
- Medical subject headings
- Obesity, Intermittent Fasting, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feeding armOther
80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours
usual feeding pattern armOther
All meals consumed ad lib with 50% of calories consumed after 4PM
| Study group | Role | What they receive |
|---|---|---|
| Timed restricted feeding | Experimental | Time restricted feeding then usual feeding pattern Day 1, testing
Day 2-7 all meals will be consumed as follows:
80% of calories consumed before 2 PM with remaining 20% consumed by 4PM. Fasting except for water, non caloric drinks for 14-16 hours Same number of calories consumed as in usual feeding pattern arm. Day 8 testing. Day 9-14 crossover to usual feeding pattern arm (meals consumed ad lib with 50% of calories consumed after 4 PM) for 6 days. Receives: Other: Time restricted feeding arm; Other: usual feeding pattern arm |
| Usual feeding pattern | Experimental | Usual feeding pattern, then time restricted feeding Day 1 testing
Day 2-7 all meals will be consumed as follows:
Meals consumed ad lib with 50% of calories consumed after 4 PM. Day 8 testing. Day 9-14 crossover to time restricted feeding arm with all meals consumed as follows:
80% of calories consumed before 2 PM with remaining 20% consumed by 4PM. Fasting except for water, non caloric drinks for 14-16 hours Same number of calories consumed as in usual feeding pattern arm for 6 days. Receives: Other: Time restricted feeding arm; Other: usual feeding pattern arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic variation by mean amplitude of glycemic excursion (MAGE)
Measured: Day 2-Day14
Change in inflammatory marker concentrations (sRAGE and hsCRP) relative to the UFP arm
Measured: Day 2-Day 14
Secondary outcomes (4)
Shift from glucogenic to ketogenic metabolism in the TRF arm relative to the UFP arm by plasma metabolomics
Measured: Day 2- Day 14
Change in biological indices of appetite (incretins) in TRF arm relative to UFP arm.
Measured: Day 2 - Day 14
Changes in WBC transcriptomic profiles versus UFP arm between1, 7 and 14 days.
Measured: Day 2 - Day 14
changes in gut mirobiome profiles in the TRFarm
Measured: Day 2 - Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start10 Jun 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Crossover
- Model description
- 10 obese, pre-diabetic participants will be randomly assigned to usual eating pattern vs timed restricted eating over 5 days as inpatient in a metabolic unit. They will undergo baseline and post-intervention measurements of glucose tolerance, body compostion by Bod Pod, continuous glucose monitoring by Free-Syle Libre monitor and donate blood for markers of inflammation. They will consume their usual pre-study diet. After completing Arm I, they will cross-over to Arm 2.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884659
- Sponsor's protocol ID
- JAL-1007
- Acronym
- TRIO
- Status last verified
- Aug 2022
- First submitted
- 7 May 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Time-Restricted Feeding on Metabolism and Inflammation in Obesity (TRIO Study)
- ClinicalTrials.gov ID
- NCT04884659
- Acronym / sponsor ID
- TRIO / JAL-1007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 13 May 2021 (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.
We propose to conduct a randomized 6-day isocaloric crossover feeding study in humans with prediabetes and obesity. We will study the effect of restricting the timing of caloric intake to earlier in the day (TRF) versus later in the day (usual feeding pattern, UFP) on glycemia and inflammation in an inpatient setting.
Detailed description
Time Restricted Feeding (TRF) is a variant of intermittent fasting that confines caloric intake to active daytime hours and involves fasting for 12 to 14 hours. Circadian misalignment caused by changes in sleeping and eating behaviors has emerged as having a detrimental impact on weight, glucose homeostasis and other cardiovascular disease-related outcomes. Feeding during active periods appears to be advantageous for weight, glucose metabolism and lipid profiles whereas feeding during the inactive period confers deleterious effects on these outcomes. Therefore, TRF shows great promise as a novel intervention for addressing obesity and related cardiovascular outcomes.
Animal studies suggest that timing of feeding, including intermittent fasting or TRF, decreases inflammation and causes ketosis. Human studies that examined time restricted feeding for improvement in glycemia in as little as 4 days did not observe changes in clinical markers of inflammarion such as hsCRP. Moreover, systemic and adipose tissue inflammation as it occurs in obesity shows dynamic changes in the context of weight loss that would not be clearly apparent in a weight stable state. A potential mechanistic link between glycemic improvement and systemic inflammation would be the Receptor for Advanced Glycation End-Products (RAGE) and its soluble form (sRAGE).This form of inflammation has not been measured in reported eTRF studies and its relationship with eTRFwould bea significant contribution from the proposed study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 10 obese, pre-diabetic participants will be randomly assigned to usual eating pattern vs timed restricted eating over 5 days as inpatient in a metabolic unit. They will undergo baseline and post-intervention measurements of glucose tolerance, body compostion by Bod Pod, continuous glucose monitoring by Free-Syle Libre monitor and donate blood for markers of inflammation. They will consume their usual pre-study diet. After completing Arm I, they will cross-over to Arm 2.
| Arm | Type | Receives |
|---|---|---|
| Timed restricted feeding | Experimental | Other: Time restricted feeding arm, Other: usual feeding pattern armTime restricted feeding then usual feeding pattern Day 1, testing Day 2-7 all meals will be consumed as follows: 80% of calories consumed before 2 PM with remaining 20% consumed by 4PM. Fasting except for water, non caloric drinks for 14-16 hours Same number of calories consumed as in usual feeding pattern arm. Day 8 testing. Day 9-14 crossover to usual feeding pattern arm (meals consumed ad lib with 50% of calories consumed after 4 PM) for 6 days. |
| Usual feeding pattern | Experimental | Other: Time restricted feeding arm, Other: usual feeding pattern armUsual feeding pattern, then time restricted feeding Day 1 testing Day 2-7 all meals will be consumed as follows: Meals consumed ad lib with 50% of calories consumed after 4 PM. Day 8 testing. Day 9-14 crossover to time restricted feeding arm with all meals consumed as follows: 80% of calories consumed before 2 PM with remaining 20% consumed by 4PM. Fasting except for water, non caloric drinks for 14-16 hours Same number of calories consumed as in usual feeding pattern arm for 6 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BMI >25 kg/m2
- If taking probiotics during screening, must agree to continue taking them at the same dosage and frequency
- HbA1C 5.7-6.4%
- Willing to eat only the food provided
- Willing to follow the feeding schedule, including fasting for 14 hours/day for 7 days
Key exclusion criteria (14 listed)
- Diabetes
- Any intermittent feeding diet within the last 2 weeks
- HIV positive
- Hepatitis
- Self-reported autoimmune diseases (rheumatoid arthritis, SLE (lupus), Crohn's
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 |
|---|---|---|
| Time restricted feeding arm80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours | Other | Timed restricted feeding, Usual feeding pattern |
| usual feeding pattern armAll meals consumed ad lib with 50% of calories consumed after 4PM | Other | Timed restricted feeding, Usual feeding pattern |
Primary outcome
Change in glycemic variation by mean amplitude of glycemic excursion (MAGE)
Time frame: Day 2-Day14
Change in inflammatory marker concentrations (sRAGE and hsCRP) relative to the UFP arm
Time frame: Day 2-Day 14
4 secondary outcomes
Shift from glucogenic to ketogenic metabolism in the TRF arm relative to the UFP arm by plasma metabolomics
Time frame: Day 2- Day 14
Change in biological indices of appetite (incretins) in TRF arm relative to UFP arm.
Time frame: Day 2 - Day 14
Changes in WBC transcriptomic profiles versus UFP arm between1, 7 and 14 days.
Time frame: Day 2 - Day 14
changes in gut mirobiome profiles in the TRFarm
Time frame: Day 2 - Day 14
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 24 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted feeding arm and usual feeding pattern arm in people with Obesity and Inflammatory Markers, run by Rockefeller University 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 8 inclusion and 14 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 24 Aug 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?
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 glycemic variation by mean amplitude of glycemic excursion (MAGE) (time frame: Day 2-Day14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2022.