Effects of Adding L-BAIBA to Exercising Adult Overweight and Obese Men and Women

Trial details

Who runs it

Lindenwood University

Trial code

NCT05775016

Record updated

29 July 2024

Original description

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 full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year; 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; 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; 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 or is being treated for some form of thyroid disease; 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.); Have a known sensitivity or allergy to any of the study products; 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; Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL); 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; Participants who are lactating, pregnant or planning to become pregnant; 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.

ClinicalTrials.gov NCT05775016