ObesityPROEMNCT04093453
The Acute Effect of Propionate on Energy Homeostasis
A study testing Exercise and Sodium Propionate in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The research project aims to examine the effect of a dietary supplement called propionate on how the human body in healthy adults aged (18- 65 years) responds to during fasting, exercise and following a liquid mixed meal test and how that would affect energy homeostasis and substrate oxidation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise and Sodium Propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2018to 7 Aug 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (body mass index (BMI) of 18-35 kg/m2)
- Age between 18-65 years (inclusive)
Who cannot join
- Weight change of ≥ 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
- Diabetes
Show all 14Show fewer
- Cardiovascular disease
- Cancer
- Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
- Kidney disease
- Liver disease
- Pancreatitis
- Started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
- Involved in current research or have recently been involved in any research prior to recruitment in the past 12 weeks.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Clinical Research Facility
London, W12 0HS
About this study
The research project aims to examine the effect of a dietary supplement called propionate on how the human body in healthy adults aged (18- 65 years) responds to during fasting, exercise and following a liquid mixed meal test and how that would affect energy homeostasis and substrate oxidation.
Read the detailed description
Dietary fibres have long been recognised for their important role in a healthy diet due to their negative association with, and even management of, chronic diseases such as obesity, diabetes, metabolic syndrome, cardiovascular disease and inflammatory-bowel disease among others.Emerging evidence has suggested that these benefits could largely be attributed to short chain fatty acids (SCFA) (acetate, propionate and butyrate), the main by-products of fibre fermentation in the gut. Previous research has demonstrated that a long-term elevation in the SCFA propionate significantly reduced body weight gain in overweight adults and reduced liver fat storage.
The current project will examine potential mechanisms for the positive effect of propionate on energy homeostasis and metabolic profile.The effects of propionate on circulating glucose, insulin, gut hormones and lipid levels at rest, following moderate-intensity exercise and mixed meal tolerance test will be examined.
To acutely increase propionate absorption from the gut the present project will use a simple nutritional supplement: sodium propionate in a hydroxypropylmethyl cellulose (HPMC) capsule. This capsule is coated with an enteric film which prevents gastric digestion until the capsule reaches the intestine. This nutritional supplement has been used in human volunteers in a previously approved ethics application (12/LO/1769: Oral propionate and glucose homeostasis). A 5g acute dose of sodium propionate had previously been tested and reported no adverse effects . The MHRA have confirmed that encapsulated sodium propionate is not classed as an investigative medicinal product.
- Conditions
- Obesity
- Being tested
- Placebo (Sodium Chloride), Exercise, Sodium Propionate
- Keywords
- Short Chain Fatty Acids, Propionate, Energy Expenditure, Lipid Oxidation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Sodium Chloride)Other
Participant receive Placebo (Sodium Chloride)
ExerciseOther
1 hour exercise
Sodium PropionateDietary supplement
Participant receive Sodium Propionate
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Fasting | Placebo comparator | Sodium Chloride tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Receives: Other: Placebo (Sodium Chloride) |
| Placebo + Exercise | Placebo comparator | Sodium Chloride tested in an exercise state. Participants will have the placebo then exercise will be performed at 40% of maximal aerobic capacity for one hour. Receives: Other: Placebo (Sodium Chloride); Other: Exercise |
| Placebo + Post-prandial | Placebo comparator | Sodium Chloride tested in a post-prandial state. Participants will have the placebo then a mixed liquid meal test is given. Receives: Other: Placebo (Sodium Chloride) |
| Propionate and Fasting | Experimental | Sodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). Receives: Dietary Supplement: Sodium Propionate |
| Propionate and Exercise | Experimental | Sodium Propionate tested in an exercise state. Participants will have the sodium propionate then exercise will be performed at 40% of maximal aerobic capacity for one hour. Receives: Other: Exercise; Dietary Supplement: Sodium Propionate |
| Propionate and Post-prandial | Experimental | Sodium Propionate tested in a post-prandial state. Participants will have the sodium propionate then a mixed liquid meal test is given. Receives: Dietary Supplement: Sodium Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Resting Energy Expenditure
Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control).
Measured: 6 hours
Changes in Resting Lipid Oxidation
Changes in Resting Lipid Oxidation between sodium propionate and sodium chloride (control).
Measured: 6 hours
Changes in Energy Expenditure During Exercise
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) during exercise.
Measured: 240 minutes
Changes in Lipid Oxidation During Exercise
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) during exercise.
Measured: 240 minutes
Changes in Energy Expenditure Post-prandially
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) post-prandially.
Measured: 300 minutes
Changes in Lipid Oxidation Post-prandially
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) post-prandially.
Measured: 300 minutes
Changes in Glucose Concentrations Post-prandially
Changes in glucose concentrations between sodium propionate and sodium chloride (control) post-prandially.
Measured: 300 minutes
Changes in Glucose Concentrations During Exercise
Changes in glucose concentrations between sodium propionate and sodium chloride (control) during exercise.
Measured: 240 minutes
Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm).
Changes in subjective thirst between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Measured: 300 minutes
Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm)
Changes in subjective thirst between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Measured: 240 minutes
Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm)
Changes in subjective nausea between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea.
Measured: 240 minutes
Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm)
Changes in subjective hunger between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
Measured: 240 minutes
Secondary outcomes (11)
Changes in GLP-1 Concentration
Changes in GLP-1 concentrations between sodium propionate and sodium chloride (control) post-prandially.
Measured: 300 minutes
Changes in Insulin Concentration
Changes in insulin concentrations between sodium propionate and sodium chloride (control) during fasting
Measured: 360 minutes
Changes in Glucose Concentration
Changes in glucose concentrations between sodium propionate and sodium chloride (control) during fasting
Measured: 360 minutes
Changes in Free Fatty Acid Concentration
Changes in free fatty acid concentrations between sodium propionate and sodium chloride (control) during fasting
Measured: 360 minutes
Changes in Subjective Nausea With Visual Analog Scales (100 mm)
Changes in subjective nausea between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea.
Measured: 360 minutes
Changes in Subjective Hunger With Visual Analog Scales (100 mm)
Changes in subjective hunger between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
Measured: 360 minutes
Changes in Subjective Thirst Using Visual Analog Scales (100 mm)
Changes in subjective thirst between sodium propionate and sodium chloride (control) during fasting. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Measured: 360 minutes
Changes in Insulin Concentration
Changes in insulin concentrations between sodium propionate and sodium chloride (control) during exercise
Measured: 240 minutes
Changes in Insulin Concentration
Changes in insulin concentrations between sodium propionate and sodium chloride (control) post-prandially.
Measured: 300 minutes
Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially
Changes in subjective nausea between sodium propionate and sodium chloride (control) post-prandially.
Measured: 300 minutes
Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm)
Changes in subjective hunger between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
Measured: 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start12 Feb 2018
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
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.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This protocol consisted of three individual trials.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Chambers, PhD, Study director, Imperial College LondonGary Frost, Professor, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093453
- Sponsor's protocol ID
- 18hh4373
- Acronym
- PROEM
- Status last verified
- Mar 2024
- First submitted
- 5 Aug 2019
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Propionate on Energy Homeostasis
- ClinicalTrials.gov ID
- NCT04093453
- Acronym / sponsor ID
- PROEM / 18hh4373
- Conditions
- Obesity
- Keywords
- Short Chain Fatty Acids, Propionate, Energy Expenditure, Lipid Oxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research project aims to examine the effect of a dietary supplement called propionate on how the human body in healthy adults aged (18- 65 years) responds to during fasting, exercise and following a liquid mixed meal test and how that would affect energy homeostasis and substrate oxidation.
Detailed description
Dietary fibres have long been recognised for their important role in a healthy diet due to their negative association with, and even management of, chronic diseases such as obesity, diabetes, metabolic syndrome, cardiovascular disease and inflammatory-bowel disease among others.Emerging evidence has suggested that these benefits could largely be attributed to short chain fatty acids (SCFA) (acetate, propionate and butyrate), the main by-products of fibre fermentation in the gut. Previous research has demonstrated that a long-term elevation in the SCFA propionate significantly reduced body weight gain in overweight adults and reduced liver fat storage.
The current project will examine potential mechanisms for the positive effect of propionate on energy homeostasis and metabolic profile.The effects of propionate on circulating glucose, insulin, gut hormones and lipid levels at rest, following moderate-intensity exercise and mixed meal tolerance test will be examined.
To acutely increase propionate absorption from the gut the present project will use a simple nutritional supplement: sodium propionate in a hydroxypropylmethyl cellulose (HPMC) capsule. This capsule is coated with an enteric film which prevents gastric digestion until the capsule reaches the intestine. This nutritional supplement has been used in human volunteers in a previously approved ethics application (12/LO/1769: Oral propionate and glucose homeostasis). A 5g acute dose of sodium propionate had previously been tested and reported no adverse effects . The MHRA have confirmed that encapsulated sodium propionate is not classed as an investigative medicinal product.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- This protocol consisted of three individual trials.
| Arm | Type | Receives |
|---|---|---|
| Placebo + Fasting | Placebo comparator | Other: Placebo (Sodium Chloride)Sodium Chloride tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). |
| Placebo + Exercise | Placebo comparator | Other: Placebo (Sodium Chloride), Other: ExerciseSodium Chloride tested in an exercise state. Participants will have the placebo then exercise will be performed at 40% of maximal aerobic capacity for one hour. |
| Placebo + Post-prandial | Placebo comparator | Other: Placebo (Sodium Chloride)Sodium Chloride tested in a post-prandial state. Participants will have the placebo then a mixed liquid meal test is given. |
| Propionate and Fasting | Experimental | Dietary Supplement: Sodium PropionateSodium Propionate tested in a fasting state. Participants will be fasting for duration of study visit (360 minutes). |
| Propionate and Exercise | Experimental | Other: Exercise, Dietary Supplement: Sodium PropionateSodium Propionate tested in an exercise state. Participants will have the sodium propionate then exercise will be performed at 40% of maximal aerobic capacity for one hour. |
| Propionate and Post-prandial | Experimental | Dietary Supplement: Sodium PropionateSodium Propionate tested in a post-prandial state. Participants will have the sodium propionate then a mixed liquid meal test is given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers (body mass index (BMI) of 18-35 kg/m2)
- Age between 18-65 years (inclusive)
Key exclusion criteria (14 listed)
- Weight change of ≥ 3kg in the preceding 2 months
- Current smokers
- Substance abuse
- Excess alcohol intake
- Pregnancy
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 |
|---|---|---|
| Placebo (Sodium Chloride)Participant receive Placebo (Sodium Chloride) | Other | Placebo + Exercise, Placebo + Fasting, Placebo + Post-prandial |
| Exercise1 hour exercise | Other | Placebo + Exercise, Propionate and Exercise |
| Sodium PropionateParticipant receive Sodium Propionate | Dietary supplement | Propionate and Exercise, Propionate and Fasting, Propionate and Post-prandial |
Primary outcome
Changes in Resting Energy Expenditure
Time frame: 6 hours
Changes in Resting Energy Expenditure between sodium propionate and sodium chloride (control).
Changes in Resting Lipid Oxidation
Time frame: 6 hours
Changes in Resting Lipid Oxidation between sodium propionate and sodium chloride (control).
Changes in Energy Expenditure During Exercise
Time frame: 240 minutes
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) during exercise.
Changes in Lipid Oxidation During Exercise
Time frame: 240 minutes
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) during exercise.
Changes in Energy Expenditure Post-prandially
Time frame: 300 minutes
Changes in Energy Expenditure between sodium propionate and sodium chloride (control) post-prandially.
Changes in Lipid Oxidation Post-prandially
Time frame: 300 minutes
Changes in Lipid Oxidation between sodium propionate and sodium chloride (control) post-prandially.
Changes in Glucose Concentrations Post-prandially
Time frame: 300 minutes
Changes in glucose concentrations between sodium propionate and sodium chloride (control) post-prandially.
Changes in Glucose Concentrations During Exercise
Time frame: 240 minutes
Changes in glucose concentrations between sodium propionate and sodium chloride (control) during exercise.
Changes in Subjective Thirst Post-prandially Using a Visual Analog Scale (100 mm).
Time frame: 300 minutes
Changes in subjective thirst between sodium propionate and sodium chloride (control) post-prandially. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Changes in Subjective Thirst During Exercise With Visual Analog Scales (100 mm)
Time frame: 240 minutes
Changes in subjective thirst between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective thirst. High (100 mm) mean high subjective thirst.
Changes in Subjective Nausea During Exercise With Visual Analog Scales (100 mm)
Time frame: 240 minutes
Changes in subjective nausea between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective nausea. High (100 mm) mean high subjective nausea.
Changes in Subjective Hunger During Exercise With Visual Analog Scales (100 mm)
Time frame: 240 minutes
Changes in subjective hunger between sodium propionate and sodium chloride (control) during exercise. Volunteers completed the visual analog scale using a pen (Biro, black) with scales printed (Sharp MX-7580N ) on paper (A4, white). Visual analog scales were 100 mm in length. Minimum (0 mm) mean low subjective hunger. High (100 mm) mean high subjective hunger.
11 secondary outcomes
Changes in GLP-1 Concentration
Time frame: 300 minutes
Changes in Insulin Concentration
Time frame: 360 minutes
Changes in Glucose Concentration
Time frame: 360 minutes
Changes in Free Fatty Acid Concentration
Time frame: 360 minutes
Changes in Subjective Nausea With Visual Analog Scales (100 mm)
Time frame: 360 minutes
Changes in Subjective Hunger With Visual Analog Scales (100 mm)
Time frame: 360 minutes
Changes in Subjective Thirst Using Visual Analog Scales (100 mm)
Time frame: 360 minutes
Changes in Insulin Concentration
Time frame: 240 minutes
Changes in Insulin Concentration
Time frame: 300 minutes
Changes in Subjective Nausea Between Sodium Propionate and Sodium Chloride Post-prandially
Time frame: 300 minutes
Changes in Subjective Hunger Between Sodium Propionate and Sodium Chloride Post-prandially With Visual Analog Scales (100 mm)
Time frame: 300 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
Edward Chambers, PhD study director
Imperial College London
Gary Frost, Professor principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Sodium Propionate in people with Obesity, run by Imperial College London at 1 site in United Kingdom.
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 2 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 23 Aug 2024. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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 23 Aug 2024). 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 Resting Energy Expenditure (time frame: 6 hours). The study lists 12 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 23 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.