ObesityLBCNCT05775016
Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women
A study testing Exercise in people with Obesity and Weight Loss, run by Lindenwood University at 1 site in United States.
Trial summary
Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to examine changes in body composition, weight loss, glucose control, and cardiometabolic risk factors after adding supplementation of BAIBA to exercise in overweight and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss, Weight, Body
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 23 Apr 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are between 18 - 60 years of age
- Body mass index values will range from >25.0 to < 32.0 kg/m2, making them qualified as an overweight-to-obese population (https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm)
- Average body mass index for entire study cohort will be less than 30.0 kg/m2. As such an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 30.0 kg/m2
- Free-living/uninhibited with use of ambulatory assistive devices (e.g. canes, crutches, walkers, etc.) and independent
- In good health absent of being overweight or mildly obese with no other signs or symptoms of cardiovascular, respiratory, metabolic, immune, psychiatric, or musculoskeletal disease or disorders
- Willingness to maintain consistent sleep duration the evening before study visits
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures
- Able to complete a peak oxygen consumption exercise test with no contraindications to perform exercise per standards put forth by the American College of Sports Medicine. In other words, they are able to safety complete maximal exercise.
Who cannot join
- Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease
- Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals
- Has liver disease or some form of clinically diagnosed hepatic impairment
- Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
- Diagnosed with or is being treated for some form of thyroid disease
- Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
Show all 21Show fewer
- Diagnosed with some form of immune disorder (i.e., HIV/AIDS)
- History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
- Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
- Positive medical history for any neurological condition or neurological disease
- Currently prescribed a statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.)
- Current smoker (average of > 1 pack per day within the past 3 months) has quit within the past six months. This includes all forms of nicotine
- Intake of any drugs (prescribed or over the counter) or dietary supplements that are known or are purported to weight loss such as thermogenics, hydroxycitric acid, ephedra, capsaicin, etc.
- Participants who are lactating, pregnant or planning to become pregnant
- Have a known sensitivity or allergy to any of the study products
- History of alcohol or substance abuse in the 12 months prior to screening
- Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol
- They plan major changes in lifestyle (i.e., diet, dieting, exercise level, travel, etc.) during the study
- Recent history (<3 months) of exercise training or weight loss (> 5%)
- Any orthopedic limitation that would prevent participation in a general fitness program
- Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
Official title: Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women on Changes in Body Composition, Glucose Control, and Cardiometabolic Risk Factors
Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to examine changes in body composition, weight loss, glucose control, and cardiometabolic risk factors after adding supplementation of BAIBA to exercise in overweight and obese men and women.
Read the detailed description
This study will be conducted using a double-blind, placebo-controlled, parallel group design. Eligible study participants will be randomly assigned to one of three supplementation groups: placebo (resistant dextrin) supplementation + exercise group, 750 mg BAIBA supplementation + exercise group, and a 1500 mg BAIBA supplementation + exercise group. After signing an IRB-approved consent form, prospective participants will be scheduled for a screening visit where they will have their eligibility finalized through completion of a peak VO2 assessment using a motorized treadmill and metabolic cart. Eligible participants will then be fully explained the study and scheduled for a baseline testing session (week 0). Prior to scheduling this visit, participants must complete a 4-day food record. Once a food record is completed, participants will observe an overnight fast and be scheduled to complete the testing session between the hours of 0600 - 1000 hours. Upon arrival, changes in medical status, medications, and dietary supplements will be confirmed before having their body mass and hemodynamics assessed. Next, participants will have their waist circumference, body water (BIS), and body composition (DEXA) assessed to evaluate changes in body composition and obesity status throughout the study protocol. Participants will then have a venous blood sample collected for evaluation of health markers (complete blood counts, comprehensive metabolic panels, and lipid panels) before completing a resting metabolic rate measurement. The resting metabolic rate measurement will be used to prescribe energy intake throughout the study protocol. Participants will then use an electronic tablet and complete the Profile of Mood States and visual analog scales to evaluate perceptions of hunger and appetite. Participants will then be given their first daily dose. All participants will be given instructions and meal plans as well as be offered weekly educational sessions on how to restrict calories and meet protein goals throughout the study protocol. Participants will complete five days per week of exercise consisting of a mixture of walking and resistance training. Daily compliance to the exercise and supplementation groups will be monitored weekly for a 12-week period. Participants who complete at least 80% of their assigned workouts will be considered compliant and will be scheduled for follow-up visits after 6 and 12 weeks of supplementation.
- Conditions
- Obesity, Weight Loss, Weight, Body, Cardiometabolic Syndrome
- Being tested
- Exercise
- Keywords
- Obesity, Weight Loss, cardiometabolic syndrome
- Medical subject headings
- Obesity, Weight Loss, Body Weight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
12 week resistance and cardiovascular exercise program
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (Resistant Dextrin) (n=40) Receives: Behavioral: Exercise |
| 750 mg/day Mitoburn (L-BAIBA) | Experimental | 750 mg/day Mitoburn (L-BAIBA) Receives: Behavioral: Exercise |
| 1,500 mg/day Mitoburn (L-BAIBA) | Experimental | 1,500 mg/day Mitoburn (L-BAIBA) Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Mass (4-compartment)
Changes in Fat Mass (4-compartment)
Measured: 12 weeks
Secondary outcomes (11)
4-Compartment Lean mass
Changes in Lean Mass (4-compartment)
Measured: 12 weeks
Waist circumference
Changes in Waist circumference
Measured: 12 weeks
Visceral Fat (DEXA)
Changes in Visceral Fat (DEXA)
Measured: 12 weeks
Lean:Fat Ratio (DEXA)
Changes in Lean:Fat Ratio (DEXA)
Measured: 12 weeks
Body Mass
Changes in Body Mass
Measured: 12 weeks
Hunger and appetite visual analog scale
Changes in Hunger and appetite visual analog scale
Measured: 12 weeks
Profile of mood states (POMS)
Changes in Profile of mood states (POMS)
Measured: 12 weeks
Inflammatory markers (e.g. CRP, IL-6, etc.)
Changes in Inflammatory markers (e.g. CRP, IL-6, etc.)
Measured: 12 weeks
Comprehensive Metabolic Panel
Changes in Comprehensive Metabolic Panel
Measured: 12 weeks
Lipid Panel
Changes in Lipid Panel
Measured: 12 weeks
Self-reported adverse events
Occurrences of Self-reported adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start29 Mar 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Why it stopped: Study was terminated due to the withdrawal of funding, which made it impossible to continue the study.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted using a double-blind, placebo-controlled, parallel group design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775016
- Sponsor's protocol ID
- IRB-23-29
- Acronym
- LBC
- Status last verified
- Jul 2024
- First submitted
- 7 Mar 2023
- Last updated
- 29 Jul 2024
- 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 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women on Changes in Body Composition, Glucose Control, and Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT05775016
- Acronym / sponsor ID
- LBC / IRB-23-29
- Conditions
- Obesity, Weight Loss, Weight, Body, Cardiometabolic Syndrome
- Keywords
- Obesity, Weight Loss, cardiometabolic syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to the withdrawal of funding, which made it impossible to continue the study.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 20 Mar 2023 (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.
Beta-amino isobutyric acid (BAIBA) is a myokine produced in skeletal muscle and has been shown to impact how our body metabolizes fuel. We seek to examine changes in body composition, weight loss, glucose control, and cardiometabolic risk factors after adding supplementation of BAIBA to exercise in overweight and obese men and women.
Detailed description
This study will be conducted using a double-blind, placebo-controlled, parallel group design. Eligible study participants will be randomly assigned to one of three supplementation groups: placebo (resistant dextrin) supplementation + exercise group, 750 mg BAIBA supplementation + exercise group, and a 1500 mg BAIBA supplementation + exercise group. After signing an IRB-approved consent form, prospective participants will be scheduled for a screening visit where they will have their eligibility finalized through completion of a peak VO2 assessment using a motorized treadmill and metabolic cart. Eligible participants will then be fully explained the study and scheduled for a baseline testing session (week 0). Prior to scheduling this visit, participants must complete a 4-day food record. Once a food record is completed, participants will observe an overnight fast and be scheduled to complete the testing session between the hours of 0600 - 1000 hours. Upon arrival, changes in medical status, medications, and dietary supplements will be confirmed before having their body mass and hemodynamics assessed. Next, participants will have their waist circumference, body water (BIS), and body composition (DEXA) assessed to evaluate changes in body composition and obesity status throughout the study protocol. Participants will then have a venous blood sample collected for evaluation of health markers (complete blood counts, comprehensive metabolic panels, and lipid panels) before completing a resting metabolic rate measurement. The resting metabolic rate measurement will be used to prescribe energy intake throughout the study protocol. Participants will then use an electronic tablet and complete the Profile of Mood States and visual analog scales to evaluate perceptions of hunger and appetite. Participants will then be given their first daily dose. All participants will be given instructions and meal plans as well as be offered weekly educational sessions on how to restrict calories and meet protein goals throughout the study protocol. Participants will complete five days per week of exercise consisting of a mixture of walking and resistance training. Daily compliance to the exercise and supplementation groups will be monitored weekly for a 12-week period. Participants who complete at least 80% of their assigned workouts will be considered compliant and will be scheduled for follow-up visits after 6 and 12 weeks of supplementation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study will be conducted using a double-blind, placebo-controlled, parallel group design.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: ExercisePlacebo (Resistant Dextrin) (n=40) |
| 750 mg/day Mitoburn (L-BAIBA) | Experimental | Behavioral: Exercise750 mg/day Mitoburn (L-BAIBA) |
| 1,500 mg/day Mitoburn (L-BAIBA) | Experimental | Behavioral: Exercise1,500 mg/day Mitoburn (L-BAIBA) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants who are between 18 - 60 years of age
- Body mass index values will range from >25.0 to < 32.0 kg/m2, making them qualified as an overweight-to-obese population (https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm)
- Average body mass index for entire study cohort will be less than 30.0 kg/m2. As such an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 30.0 kg/m2
- Free-living/uninhibited with use of ambulatory assistive devices (e.g. canes, crutches, walkers, etc.) and independent
- In good health absent of being overweight or mildly obese with no other signs or symptoms of cardiovascular, respiratory, metabolic, immune, psychiatric, or musculoskeletal disease or disorders
Key exclusion criteria (21 listed)
- Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease
- Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals
- Has liver disease or some form of clinically diagnosed hepatic impairment
- Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
- Diagnosed with or is being treated for some form of thyroid disease
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 |
|---|---|---|
| Exercise12 week resistance and cardiovascular exercise program | Behavioural | 1,500 mg/day Mitoburn (L-BAIBA), 750 mg/day Mitoburn (L-BAIBA), Placebo |
Primary outcome
Fat Mass (4-compartment)
Time frame: 12 weeks
Changes in Fat Mass (4-compartment)
11 secondary outcomes
4-Compartment Lean mass
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Visceral Fat (DEXA)
Time frame: 12 weeks
Lean:Fat Ratio (DEXA)
Time frame: 12 weeks
Body Mass
Time frame: 12 weeks
Hunger and appetite visual analog scale
Time frame: 12 weeks
Profile of mood states (POMS)
Time frame: 12 weeks
Inflammatory markers (e.g. CRP, IL-6, etc.)
Time frame: 12 weeks
Comprehensive Metabolic Panel
Time frame: 12 weeks
Lipid Panel
Time frame: 12 weeks
Self-reported adverse events
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study was terminated due to the withdrawal of funding, which made it impossible to continue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Chad M Kerksick, PhD principal investigator
Lindenwood University
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 in people with Obesity and Weight Loss, run by Lindenwood 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 21 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: stopped early, as of the sponsor's last update on 29 Jul 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 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.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to the withdrawal of funding, which made it impossible to continue the study.). Results are not available in the source record.
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?
Fat Mass (4-compartment) (time frame: 12 weeks). 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 29 Jul 2024.