ObeseGOPNCT05775003
Effects of Adding L-BAIBA or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese Men and Women
A study testing Exercise in people with Obese and Weight Loss, run by Lindenwood University at 1 site in United States.
Trial summary
The goal of this intervention study is to examine changes in body composition, weight loss, and cardio-metabolic risk factors after adding supplementation of L-Beta aminoisobutyric acid (L-BAIBA) and Grains of Paradise to exercise in overweight and obese men and women. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese, Weight Loss, Body Weight
- What is being tested?
- Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 1 Oct 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
Show all 9Show fewer
- 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) or 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 or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese Men and Women on Changes in Body Composition, Resting Metabolic, and Cardiometabolic Risk Factors
The goal of this intervention study is to examine changes in body composition, weight loss, and cardio-metabolic risk factors after adding supplementation of L-Beta aminoisobutyric acid (L-BAIBA) and Grains of Paradise to exercise in overweight and obese men and women. Participants will supplement for 8 weeks and complete a 8 week exercise protocol.
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 starch) supplementation + exercise group, 500 mg BAIBA supplementation + exercise group, and a 500 mg BAIBA supplementation + 40 mg Grains of Paradise + 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. After hemodynamic assessment, participants will have the first of two resting metabolic rate measurements completed before having a venous blood sample collected for evaluation of health markers (complete blood counts, comprehensive metabolic panels, and lipid panels). Participants will then use an electronic tablet and complete the Profile of Mood States and visual analog scales to evaluate perceptions of energy, focus, attention, hunger, appetite, and concentration. Participants will then be given their daily dose and a timer will be started. From there, participants will have their waist circumference, body water (BIS), and body composition (DEXA) assessed. After completion of these, participants will then wait in the laboratory until an hour has passed and will have a second resting metabolic rate measurement completed. After the second resting metabolic rate measurement, participants will have a second venous blood sample collected to evaluate changes in glycerol. 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 an 8-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 2, 4, and 8 weeks of supplementation.
Participants will be asked to follow an 8-10 hour dry fast and to refrain from caffeine, alcohol, nicotine, and exercise (excluding the 30 min daily walk) for 24 hours prior to each study visit.
- Conditions
- Obese, Weight Loss, Body Weight, Cardiometabolic Syndrome
- Being tested
- Exercise
- Keywords
- weight loss, body composition, 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.
ExerciseDietary supplement
Also called Exercise training
8 week exercise training program - consisting of weight training and cardiovascular exercise
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Resistant starch Receives: Dietary Supplement: Exercise |
| 500 mg BAIBA supplementation | Experimental | 500 mg BAIBA supplementation Receives: Dietary Supplement: Exercise |
| 500 mg BAIBA supplementation + 40 mg Grains of Paradise | Experimental | 500 mg BAIBA supplementation + 40 mg Grains of Paradise Receives: Dietary Supplement: 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 using a 4 compartment model
Measured: 8 Weeks
Secondary outcomes (14)
Lean mass (4-Compartment)
changes in lean mass using a 4 compartment model
Measured: 8 weeks
Waist circumference
Changes in waist circumference
Measured: 8 weeks
Visceral Fat (DEXA)
Changes in Visceral Fat (DEXA)
Measured: 8 weeks
Lean:Fat Ratio (DEXA)
Changes in Lean:Fat Ratio (DEXA)
Measured: 8 weeks
Body Mass
Changes in Body Mass
Measured: 8 weeks
Hunger and appetite visual analog scale
Changes in Hunger and appetite visual analog scale. Minimum score is 0. Maximum score is 100. Lower is better.
Measured: 8 weeks
Energy, focus, attention, and concentration visual analog scales
Changes in Energy, focus, attention, and concentration visual analog scales. Minimum score is 0. Maximum score is 100. Higher is better.
Measured: 8 weeks
Profile of mood states (POMS)
Changes in Profile of mood states (POMS) Minimum score is 0. Maximum score is 5 for each question. A higher Total Mood Disturbance score is worse, lower is better.
Measured: 8 weeks
Serum Glycerol
Changes in Serum Glycerol Levels
Measured: 8 weeks
Fasting glucose
Changes in Fasting glucose
Measured: 8 weeks
Complete Blood Count
Changes in Complete Blood Count
Measured: 8 weeks
Comprehensive Metabolic Panel
Changes in Comprehensive Metabolic Panel
Measured: 8 weeks
Lipid Panel
Changes in Lipid Panel
Measured: 8 weeks
Self-reported adverse events
Occurrences of Self-reported adverse events
Measured: 8 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 start11 Apr 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies 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. Eligible study participants will be randomly assigned to one of three supplementation groups: placebo (resistant starch) supplementation + exercise group, 500 mg BAIBA supplementation + exercise group, and a 500 mg BAIBA supplementation + 40 mg Grains of Paradise + exercise group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 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
- NCT05775003
- Sponsor's protocol ID
- IRB-23-28
- Acronym
- GOP
- Status last verified
- Oct 2024
- First submitted
- 7 Mar 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson JP, Fan B, Shepherd JA. Total and regional body volumes derived from dual-energy X-ray absorptiometry output. J Clin Densitom. 2013 Jul-Sep;16(3):368-373. doi: 10.1016/j.jocd.2012.11.001. Epub 2013 Jan 12.
PubMed 23321490Smith-Ryan AE, Mock MG, Ryan ED, Gerstner GR, Trexler ET, Hirsch KR. Validity and reliability of a 4-compartment body composition model using dual energy x-ray absorptiometry-derived body volume. Clin Nutr. 2017 Jun;36(3):825-830. doi: 10.1016/j.clnu.2016.05.006. Epub 2016 May 15.
PubMed 27237796Layman DK, Evans E, Baum JI, Seyler J, Erickson DJ, Boileau RA. Dietary protein and exercise have additive effects on body composition during weight loss in adult women. J Nutr. 2005 Aug;135(8):1903-10. doi: 10.1093/jn/135.8.1903.
PubMed 16046715Kerksick C, Thomas A, Campbell B, Taylor L, Wilborn C, Marcello B, Roberts M, Pfau E, Grimstvedt M, Opusunju J, Magrans-Courtney T, Rasmussen C, Wilson R, Kreider RB. Effects of a popular exercise and weight loss program on weight loss, body composition, energy expenditure and health in obese women. Nutr Metab (Lond). 2009 May 14;6:23. doi: 10.1186/1743-7075-6-23.
PubMed 19442301Kerksick CM, Wismann-Bunn J, Fogt D, Thomas AR, Taylor L, Campbell BI, Wilborn CD, Harvey T, Roberts MD, La Bounty P, Galbreath M, Marcello B, Rasmussen CJ, Kreider RB. Changes in weight loss, body composition and cardiovascular disease risk after altering macronutrient distributions during a regular exercise program in obese women. Nutr J. 2010 Nov 22;9:59. doi: 10.1186/1475-2891-9-59.
PubMed 21092228Kerksick CM, Roberts MD, Campbell BI, Galbreath MM, Taylor LW, Wilborn CD, Lee A, Dove J, Bunn JW, Rasmussen CJ, Kreider RB. Differential Impact of Calcium and Vitamin D on Body Composition Changes in Post-Menopausal Women Following a Restricted Energy Diet and Exercise Program. Nutrients. 2020 Mar 7;12(3):713. doi: 10.3390/nu12030713.
PubMed 32156010Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874.
PubMed 25593845
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding L-BAIBA or L-BAIBA + Grains of Paradise to Exercising Adult Overweight and Obese Men and Women on Changes in Body Composition, Resting Metabolic, and Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT05775003
- Acronym / sponsor ID
- GOP / IRB-23-28
- Conditions
- Obese, Weight Loss, Body Weight, Cardiometabolic Syndrome
- Keywords
- weight loss, body composition, cardiometabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 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.
The goal of this intervention study is to examine changes in body composition, weight loss, and cardio-metabolic risk factors after adding supplementation of L-Beta aminoisobutyric acid (L-BAIBA) and Grains of Paradise to exercise in overweight and obese men and women. Participants will supplement for 8 weeks and complete a 8 week exercise protocol.
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 starch) supplementation + exercise group, 500 mg BAIBA supplementation + exercise group, and a 500 mg BAIBA supplementation + 40 mg Grains of Paradise + 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. After hemodynamic assessment, participants will have the first of two resting metabolic rate measurements completed before having a venous blood sample collected for evaluation of health markers (complete blood counts, comprehensive metabolic panels, and lipid panels). Participants will then use an electronic tablet and complete the Profile of Mood States and visual analog scales to evaluate perceptions of energy, focus, attention, hunger, appetite, and concentration. Participants will then be given their daily dose and a timer will be started. From there, participants will have their waist circumference, body water (BIS), and body composition (DEXA) assessed. After completion of these, participants will then wait in the laboratory until an hour has passed and will have a second resting metabolic rate measurement completed. After the second resting metabolic rate measurement, participants will have a second venous blood sample collected to evaluate changes in glycerol. 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 an 8-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 2, 4, and 8 weeks of supplementation.
Participants will be asked to follow an 8-10 hour dry fast and to refrain from caffeine, alcohol, nicotine, and exercise (excluding the 30 min daily walk) for 24 hours prior to each study visit.
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. Eligible study participants will be randomly assigned to one of three supplementation groups: placebo (resistant starch) supplementation + exercise group, 500 mg BAIBA supplementation + exercise group, and a 500 mg BAIBA supplementation + 40 mg Grains of Paradise + exercise group.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: ExerciseResistant starch |
| 500 mg BAIBA supplementation | Experimental | Dietary Supplement: Exercise500 mg BAIBA supplementation |
| 500 mg BAIBA supplementation + 40 mg Grains of Paradise | Experimental | Dietary Supplement: Exercise500 mg BAIBA supplementation + 40 mg Grains of Paradise |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 |
|---|---|---|
| ExerciseAlso: Exercise training8 week exercise training program - consisting of weight training and cardiovascular exercise | Dietary supplement | 500 mg BAIBA supplementation, 500 mg BAIBA supplementation + 40 mg Grains of Paradise, Placebo |
Primary outcome
Fat Mass (4-Compartment)
Time frame: 8 Weeks
Changes in fat mass using a 4 compartment model
14 secondary outcomes
Lean mass (4-Compartment)
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
Visceral Fat (DEXA)
Time frame: 8 weeks
Lean:Fat Ratio (DEXA)
Time frame: 8 weeks
Body Mass
Time frame: 8 weeks
Hunger and appetite visual analog scale
Time frame: 8 weeks
Energy, focus, attention, and concentration visual analog scales
Time frame: 8 weeks
Profile of mood states (POMS)
Time frame: 8 weeks
Serum Glycerol
Time frame: 8 weeks
Fasting glucose
Time frame: 8 weeks
Complete Blood Count
Time frame: 8 weeks
Comprehensive Metabolic Panel
Time frame: 8 weeks
Lipid Panel
Time frame: 8 weeks
Self-reported adverse events
Time frame: 8 weeks
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 17 Oct 2024.
- Background: PubMed 23321490Wilson JP, Fan B, Shepherd JA. Total and regional body volumes derived from dual-energy X-ray absorptiometry output. J Clin Densitom. 2013 Jul-Sep;16(3):368-373. doi: 10.1016/j.jocd.2012.11.001. Epub 2013 Jan 12.
- Background: PubMed 27237796Smith-Ryan AE, Mock MG, Ryan ED, Gerstner GR, Trexler ET, Hirsch KR. Validity and reliability of a 4-compartment body composition model using dual energy x-ray absorptiometry-derived body volume. Clin Nutr. 2017 Jun;36(3):825-830. doi: 10.1016/j.clnu.2016.05.006. Epub 2016 May 15.
- Results publication: PubMed 16046715Layman DK, Evans E, Baum JI, Seyler J, Erickson DJ, Boileau RA. Dietary protein and exercise have additive effects on body composition during weight loss in adult women. J Nutr. 2005 Aug;135(8):1903-10. doi: 10.1093/jn/135.8.1903.
- Results publication: PubMed 19442301Kerksick C, Thomas A, Campbell B, Taylor L, Wilborn C, Marcello B, Roberts M, Pfau E, Grimstvedt M, Opusunju J, Magrans-Courtney T, Rasmussen C, Wilson R, Kreider RB. Effects of a popular exercise and weight loss program on weight loss, body composition, energy expenditure and health in obese women. Nutr Metab (Lond). 2009 May 14;6:23. doi: 10.1186/1743-7075-6-23.
- Results publication: PubMed 21092228Kerksick CM, Wismann-Bunn J, Fogt D, Thomas AR, Taylor L, Campbell BI, Wilborn CD, Harvey T, Roberts MD, La Bounty P, Galbreath M, Marcello B, Rasmussen CJ, Kreider RB. Changes in weight loss, body composition and cardiovascular disease risk after altering macronutrient distributions during a regular exercise program in obese women. Nutr J. 2010 Nov 22;9:59. doi: 10.1186/1475-2891-9-59.
- Results publication: PubMed 32156010Kerksick CM, Roberts MD, Campbell BI, Galbreath MM, Taylor LW, Wilborn CD, Lee A, Dove J, Bunn JW, Rasmussen CJ, Kreider RB. Differential Impact of Calcium and Vitamin D on Body Composition Changes in Post-Menopausal Women Following a Restricted Energy Diet and Exercise Program. Nutrients. 2020 Mar 7;12(3):713. doi: 10.3390/nu12030713.
- Results publication: PubMed 25593845Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874.
- 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.
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 Obese 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 9 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: finished, as of the sponsor's last update on 17 Oct 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 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?
Fat Mass (4-Compartment) (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775003, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.