ObesityPhase 3NCT04717726
Exercise, Milk Thistle, and Lactobacillus to Influence Plasma Bilirubin
A Phase 3 study testing Milk Thistle (MT), Lactobacillus Gasseri (LAC) and Exercise (EX) in people with Obesity, run by Kyle Flack at 1 site in United States.
Trial summary
The proposed clinical trial will test our hypothesis that, during exercise, red blood cell (RBC) release of heme and catabolism to bilirubin is an essential process that mediates gene responses that reduce body fat. 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?
- Milk Thistle (MT), Lactobacillus Gasseri (LAC) and Exercise (EX)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 19 Jul 2023
- Phase
- Phase 3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Classified as obese (BMI 30-45)
- Sedentary (do not currently exercise)
- Aged 18-50 years
- Without contraindications to exercise
Who cannot join
- Dieting for weight control
- Tobacco users
- Have a ragweed allergy
- Taking antibiotics, hypoglycemic agents, anticoagulants, statins, or NSAIDs
- Nursing, pregnant, or planning on becoming pregnant
- Supplementing with a probiotic
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky- Nutrition Assessment Lab
Lexington, Kentucky, 40506
About this study
Official title: Milk Thistle and Lactobacillus Supplementation to Improve Exercise Outcomes in Obese Patients
The proposed clinical trial will test our hypothesis that, during exercise, red blood cell (RBC) release of heme and catabolism to bilirubin is an essential process that mediates gene responses that reduce body fat. We will evaluate whether Milk Thistle extract or Lactobacillus Gasseri extends bilirubin circulating times to decrease body fat further. Thus we will perform a 12-week, 6-armed trial with one group performing aerobic exercise 5 times per week (EX) one group receiving a Milk Thistle extract (MT), one group receiving a lactobacillus gasseri supplement (LAC), a group receiving only a placebo (CON), and groups both exercising and receiving the MT (MT + EX) and lactobacillus and exercise (LAC + EX).
Read the detailed description
The investigative team's previous work has shown that BR binds to the PPARalpha protein in fat and liver tissues to activate genes that improve fatty acid oxidation via a hormone known as fibroblast growth factor-21 (FGF21). The investigators recently showed that in high capacity running rats (HCR) compared to low capacity running (LCR), in which the latter are obese, BR levels and PPARalpha-FGF21 were significantly raised in the high-capacity runners. New investigations have shown that Milk Thistle (MT) herbal supplement contains polyphenols that activate pathways that suppress the glucuronyl enzyme UGT1A1 that removes BR from the blood, improving liver function and moderately increasing BR blood levels by ~2-fold. Similar findings have been demonstrated with Lactobacillus Gasseri supplementation. Hence, there is a bilirubin-PPARalpha-FGF21 axis that can be driven by exercise and dietary supplementation. We will test whether exercise and milk thistle or exercise and lactobacillus gasseri synergistically increase bilirubin-PPARalpha-FGF21, further reducing body fat in patients with obesity.
Participants in the EX, EX + MT, and EX + LAC groups will complete five weekly exercise sessions on their own, expending roughly 600 kcal per session. Participants will be provided a Polar A-300 heart rate monitor programmed for their individual attributes (height, weight, age, training status, gender), which gives a real-time estimate of energy expenditure during exercise. Participants will report to the lab once per week to download the exercise sessions and verify compliance. If participants are not compliant (defined as completing 85% of their assigned exercise sessions per month), they will be disqualified. This intervention has been successfully used by the investigators in multiple studies to produce significant weight loss without dietary intervention in this population with a retention rate of over 90% Participants in the MT and EX + MT groups will be provided 900 mg of standardized milk thistle extract daily (300 mg three times per day before meals) over the 12-week regimen. The investigators will use the standardized Jarrow Formulas Milk Thistle Veggie Caps containing 30:1 extract that is standardized to contain 80% total Milk Thistle seed flavonoids (polyphenols), including the critical Silymarin fractions isosilybinins A and B, silybinins A and B, silychristin and silydianin that is active against suppressing the UGT1A1 enzyme increasing plasma bilirubin. The capsules are free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Rationale for using this brand: There have been inconsistencies with previous studies that did not use a standardized silymarin extract, which may have contained low levels of the active polyphenolic flavonoids in the milk thistle plant, which varies in the plant's stems, leaves, roots, and flowers.
Participants in the LAC and LAC + EX groups will receive two doses of 3 billion CFU of lactobacillus gasseri per day for a total of 6 billion CFU, the recommended upper level for supplementation of probiotic cultures. The Swanson brand Lactobacillus gasseri will be used, as these capsules are also free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Importantly, this brand uses acid-resistant designed release capsules to improve the viability of the lactobacillus in the human stomach.
Participants in the CON and EX group will receive a placebo (maltodextrin) made to look identical to the MT capsules.
- Conditions
- Obesity
- Being tested
- Milk Thistle (MT), Lactobacillus Gasseri (LAC), Exercise (EX), Control (CON)
- Keywords
- Exercise, weight loss, obesity, Lactobacillus, Milk Thistle, Bilirubin
- Medical subject headings
- Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Thistle (MT)Dietary supplement
Participants in the MT and EX + MT groups will be provided 900 mg of standardized milk thistle extract daily (300 mg three times per day before meals) over the 12-week regimen. We will use the standardized Jarrow Formulas Milk Thistle Veggie Caps containing 30:1 extract that is standardized to contain 80% total Milk Thistle seed flavonoids (polyphenols), including the critical Silymarin fractions isosilybinins A and B, silybinins A and B, silychristin and silydianin that is active against suppressing the UGT1A1 enzyme increasing plasma bilirubin. The capsules are free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Rationale for using this brand: There have been inconsistencies with previous studies that did not use a standardized silymarin extract, which may have contained low levels of the active polyphenolic flavonoids in the milk thistle plant, which varies in the plant's stems, leaves, roots, and flowers.
Lactobacillus Gasseri (LAC)Dietary supplement
Participants in the LAC and LAC + EX groups will receive two doses of 3 billion CFU of lactobacillus gasseri per day for a total of 6 billion CFU, the recommended upper level for supplementation of probiotic cultures. We will use Swanson brand Lactobacillus gasseri, whose capsules are also free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Importantly, this brand uses acid-resistant designed release capsules to improve the viability of the lactobacillus in the human stomach.
Exercise (EX)Behavioural
Participants in the EX, EX + MT, and EX + LAC groups will complete five weekly exercise sessions on their own, expending roughly 600 kcal per session. Participants will be provided a Polar A-300 heart rate monitor programmed for their individual attributes (height, weight, age, training status, gender), which gives a real-time estimate of energy expenditure during exercise. Participants will report to the lab once per week to download the exercise sessions and verify compliance. If participants are not compliant (defined as completing 85% of their assigned exercise sessions per month), they will be disqualified. This intervention has been successfully used by Dr. Flack in multiple studies to produce significant weight loss without dietary intervention in this population with a retention rate of over 90%
Control (CON)Dietary supplement
Participants in the CON and EX group will receive a placebo (maltodextrin) made to look identical to the MT and LAC capsules.
| Study group | Role | What they receive |
|---|---|---|
| MT | Experimental | Participants in the MT group will be supplemented with Milk Thistle extract for 12 weeks Receives: Dietary Supplement: Milk Thistle (MT) |
| LAC | Experimental | Participants in the LAC group will be supplemented with Lactobacillus Gassri for 12 weeks Receives: Dietary Supplement: Lactobacillus Gasseri (LAC) |
| EX | Experimental | Participants in the EX group will perform aerobic exercise, 5 days per week for 12 weeks Receives: Behavioral: Exercise (EX); Dietary Supplement: Control (CON) |
| MT + EX | Experimental | Participants in the MT + EX group will be supplemented with Milk Thistle extract and exercise for 12 weeks Receives: Dietary Supplement: Milk Thistle (MT); Behavioral: Exercise (EX) |
| LAC + EX | Experimental | Participants in the LAC + EX group will be supplemented with Lactobacillus Gassri and exercise for 12 weeks Receives: Dietary Supplement: Lactobacillus Gasseri (LAC); Behavioral: Exercise (EX) |
| CON | Placebo comparator | Participants in the CON group will be supplemented with maltodextrin pills made to look like the pills received by the MT and LAC groups for 12 weeks Receives: Dietary Supplement: Control (CON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean mass
kg of lean mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Measured: baseline (prior to initiation of study)
Lean mass
kg of lean mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Measured: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Fat mass
kg of fat mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Measured: baseline (prior to initiation of study)
Fat mass
kg of fat mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Measured: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Plasma bilirubin
Plasma bilirubin will be assessed in the fasted state
Measured: baseline (prior to initiation of study)
Plasma bilirubin
Plasma bilirubin will be assessed in the fasted state
Measured: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Plasma FGF21
fibroblast growth factor-21 will be assessed in the fasted state
Measured: baseline (prior to initiation of study)
Plasma FGF21
fibroblast growth factor-21 will be assessed in the fasted state
Measured: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Red blood cell count
Red blood cell count will be assessed in the fasted state
Measured: baseline (prior to initiation of study)
Red blood cell count
Red blood cell count will be assessed in the fasted state
Measured: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Urobilin
Plasma Urobilin will be assessed in the fasted state
Measured: baseline (prior to initiation of study)
Urobilin
Plasma Urobilin will be assessed in the fasted state
Measured: 2 weeks (immediately after 12 week exercise and/or supplement intervention)
Secondary outcomes (2)
Liver function
AST and ALT enzymes will be assessed in the fasted state to demonstrate liver health
Measured: baseline (prior to initiation of study)
Liver function
AST and ALT enzymes will be assessed in the fasted state to demonstrate liver health
Measured: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start24 Feb 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6 armmed, placebo controlled RCT
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyle Flack
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyle Flack, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717726
- Sponsor's protocol ID
- 63147
- Status last verified
- Jul 2023
- First submitted
- 13 Jan 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: unidentified participant data will be shared on figshare data repository
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Thistle and Lactobacillus Supplementation to Improve Exercise Outcomes in Obese Patients
- ClinicalTrials.gov ID
- NCT04717726
- Acronym / sponsor ID
- 63147
- Conditions
- Obesity
- Keywords
- Exercise, weight loss, obesity, Lactobacillus, Milk Thistle, Bilirubin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kyle FlackUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 22 Jan 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.
The proposed clinical trial will test our hypothesis that, during exercise, red blood cell (RBC) release of heme and catabolism to bilirubin is an essential process that mediates gene responses that reduce body fat. We will evaluate whether Milk Thistle extract or Lactobacillus Gasseri extends bilirubin circulating times to decrease body fat further. Thus we will perform a 12-week, 6-armed trial with one group performing aerobic exercise 5 times per week (EX) one group receiving a Milk Thistle extract (MT), one group receiving a lactobacillus gasseri supplement (LAC), a group receiving only a placebo (CON), and groups both exercising and receiving the MT (MT + EX) and lactobacillus and exercise (LAC + EX).
Detailed description
The investigative team's previous work has shown that BR binds to the PPARalpha protein in fat and liver tissues to activate genes that improve fatty acid oxidation via a hormone known as fibroblast growth factor-21 (FGF21). The investigators recently showed that in high capacity running rats (HCR) compared to low capacity running (LCR), in which the latter are obese, BR levels and PPARalpha-FGF21 were significantly raised in the high-capacity runners. New investigations have shown that Milk Thistle (MT) herbal supplement contains polyphenols that activate pathways that suppress the glucuronyl enzyme UGT1A1 that removes BR from the blood, improving liver function and moderately increasing BR blood levels by ~2-fold. Similar findings have been demonstrated with Lactobacillus Gasseri supplementation. Hence, there is a bilirubin-PPARalpha-FGF21 axis that can be driven by exercise and dietary supplementation. We will test whether exercise and milk thistle or exercise and lactobacillus gasseri synergistically increase bilirubin-PPARalpha-FGF21, further reducing body fat in patients with obesity.
Participants in the EX, EX + MT, and EX + LAC groups will complete five weekly exercise sessions on their own, expending roughly 600 kcal per session. Participants will be provided a Polar A-300 heart rate monitor programmed for their individual attributes (height, weight, age, training status, gender), which gives a real-time estimate of energy expenditure during exercise. Participants will report to the lab once per week to download the exercise sessions and verify compliance. If participants are not compliant (defined as completing 85% of their assigned exercise sessions per month), they will be disqualified. This intervention has been successfully used by the investigators in multiple studies to produce significant weight loss without dietary intervention in this population with a retention rate of over 90% Participants in the MT and EX + MT groups will be provided 900 mg of standardized milk thistle extract daily (300 mg three times per day before meals) over the 12-week regimen. The investigators will use the standardized Jarrow Formulas Milk Thistle Veggie Caps containing 30:1 extract that is standardized to contain 80% total Milk Thistle seed flavonoids (polyphenols), including the critical Silymarin fractions isosilybinins A and B, silybinins A and B, silychristin and silydianin that is active against suppressing the UGT1A1 enzyme increasing plasma bilirubin. The capsules are free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Rationale for using this brand: There have been inconsistencies with previous studies that did not use a standardized silymarin extract, which may have contained low levels of the active polyphenolic flavonoids in the milk thistle plant, which varies in the plant's stems, leaves, roots, and flowers.
Participants in the LAC and LAC + EX groups will receive two doses of 3 billion CFU of lactobacillus gasseri per day for a total of 6 billion CFU, the recommended upper level for supplementation of probiotic cultures. The Swanson brand Lactobacillus gasseri will be used, as these capsules are also free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Importantly, this brand uses acid-resistant designed release capsules to improve the viability of the lactobacillus in the human stomach.
Participants in the CON and EX group will receive a placebo (maltodextrin) made to look identical to the MT capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- 6 armmed, placebo controlled RCT
| Arm | Type | Receives |
|---|---|---|
| MT | Experimental | Dietary Supplement: Milk Thistle (MT)Participants in the MT group will be supplemented with Milk Thistle extract for 12 weeks |
| LAC | Experimental | Dietary Supplement: Lactobacillus Gasseri (LAC)Participants in the LAC group will be supplemented with Lactobacillus Gassri for 12 weeks |
| EX | Experimental | Behavioral: Exercise (EX), Dietary Supplement: Control (CON)Participants in the EX group will perform aerobic exercise, 5 days per week for 12 weeks |
| MT + EX | Experimental | Dietary Supplement: Milk Thistle (MT), Behavioral: Exercise (EX)Participants in the MT + EX group will be supplemented with Milk Thistle extract and exercise for 12 weeks |
| LAC + EX | Experimental | Dietary Supplement: Lactobacillus Gasseri (LAC), Behavioral: Exercise (EX)Participants in the LAC + EX group will be supplemented with Lactobacillus Gassri and exercise for 12 weeks |
| CON | Placebo comparator | Dietary Supplement: Control (CON)Participants in the CON group will be supplemented with maltodextrin pills made to look like the pills received by the MT and LAC groups for 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Classified as obese (BMI 30-45)
- Sedentary (do not currently exercise)
- Aged 18-50 years
- Without contraindications to exercise
Key exclusion criteria (6 listed)
- Dieting for weight control
- Tobacco users
- Have a ragweed allergy
- Taking antibiotics, hypoglycemic agents, anticoagulants, statins, or NSAIDs
- Nursing, pregnant, or planning on becoming pregnant
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 |
|---|---|---|
| Milk Thistle (MT)Participants in the MT and EX + MT groups will be provided 900 mg of standardized milk thistle extract daily (300 mg three times per day before meals) over the 12-week regimen. We will use the standardized Jarrow Formulas Milk Thistle Veggie Caps containing 30:1 extract that is standardized to contain 80% total Milk Thistle seed flavonoids (polyphenols), including the critical Silymarin fractions isosilybinins A and B, silybinins A and B, silychristin and silydianin that is active against suppressing the UGT1A1 enzyme increasing plasma bilirubin. The capsules are free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Rationale for using this brand: There have been inconsistencies with previous studies that did not use a standardized silymarin extract, which may have contained low levels of the active polyphenolic flavonoids in the milk thistle plant, which varies in the plant's stems, leaves, roots, and flowers. | Dietary supplement | MT, MT + EX |
| Lactobacillus Gasseri (LAC)Participants in the LAC and LAC + EX groups will receive two doses of 3 billion CFU of lactobacillus gasseri per day for a total of 6 billion CFU, the recommended upper level for supplementation of probiotic cultures. We will use Swanson brand Lactobacillus gasseri, whose capsules are also free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Importantly, this brand uses acid-resistant designed release capsules to improve the viability of the lactobacillus in the human stomach. | Dietary supplement | LAC, LAC + EX |
| Exercise (EX)Participants in the EX, EX + MT, and EX + LAC groups will complete five weekly exercise sessions on their own, expending roughly 600 kcal per session. Participants will be provided a Polar A-300 heart rate monitor programmed for their individual attributes (height, weight, age, training status, gender), which gives a real-time estimate of energy expenditure during exercise. Participants will report to the lab once per week to download the exercise sessions and verify compliance. If participants are not compliant (defined as completing 85% of their assigned exercise sessions per month), they will be disqualified. This intervention has been successfully used by Dr. Flack in multiple studies to produce significant weight loss without dietary intervention in this population with a retention rate of over 90% | Behavioural | EX, LAC + EX, MT + EX |
| Control (CON)Participants in the CON and EX group will receive a placebo (maltodextrin) made to look identical to the MT and LAC capsules. | Dietary supplement | CON, EX |
Primary outcome
Lean mass
Time frame: baseline (prior to initiation of study)
kg of lean mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Lean mass
Time frame: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
kg of lean mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Fat mass
Time frame: baseline (prior to initiation of study)
kg of fat mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Fat mass
Time frame: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
kg of fat mass will be assessed by air displacement plethysmography (BodPod, Cosmed USA)
Plasma bilirubin
Time frame: baseline (prior to initiation of study)
Plasma bilirubin will be assessed in the fasted state
Plasma bilirubin
Time frame: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Plasma bilirubin will be assessed in the fasted state
Plasma FGF21
Time frame: baseline (prior to initiation of study)
fibroblast growth factor-21 will be assessed in the fasted state
Plasma FGF21
Time frame: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
fibroblast growth factor-21 will be assessed in the fasted state
Red blood cell count
Time frame: baseline (prior to initiation of study)
Red blood cell count will be assessed in the fasted state
Red blood cell count
Time frame: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
Red blood cell count will be assessed in the fasted state
Urobilin
Time frame: baseline (prior to initiation of study)
Plasma Urobilin will be assessed in the fasted state
Urobilin
Time frame: 2 weeks (immediately after 12 week exercise and/or supplement intervention)
Plasma Urobilin will be assessed in the fasted state
2 secondary outcomes
Liver function
Time frame: baseline (prior to initiation of study)
Liver function
Time frame: 12 weeks (immediately after 12 week exercise and/or supplement intervention)
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 28 Jul 2023.
- Individual participant dataSharing planned: Yes. unidentified participant data will be shared on figshare data repository
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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 Phase 3 study testing Milk Thistle (MT), Lactobacillus Gasseri (LAC) and Exercise (EX) in people with Obesity, run by Kyle Flack 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 4 inclusion and 6 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 28 Jul 2023. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lean mass (time frame: baseline (prior to initiation of study)). 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 28 Jul 2023.