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

NCT05775016 | Terminated

• 1 other identifier: IRB-23-29
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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 obese men and women.

Conditions

Obesity; Weight Loss; Weight, Body; Cardiometabolic Syndrome

Keywords

Obesity; Weight Loss; cardiometabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Fat Mass (4-compartment)

  Changes in Fat Mass (4-compartment)

  12 weeks

Secondary Outcomes (11)

• 4-Compartment Lean mass

  12 weeks

• Waist circumference

  12 weeks

• Visceral Fat (DEXA)

  12 weeks

• Lean:Fat Ratio (DEXA)

  12 weeks

• Body Mass

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo (Resistant Dextrin) (n=40)

Behavioral: Exercise

750 mg/day Mitoburn (L-BAIBA)

EXPERIMENTAL

750 mg/day Mitoburn (L-BAIBA)

Behavioral: Exercise

1,500 mg/day Mitoburn (L-BAIBA)

EXPERIMENTAL

1,500 mg/day Mitoburn (L-BAIBA)

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

12 week resistance and cardiovascular exercise program

1,500 mg/day Mitoburn (L-BAIBA); 750 mg/day Mitoburn (L-BAIBA); Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lindenwood University: lead

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight; Metabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chad M Kerksick, PhD

  Lindenwood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Intervention will be blinded to both participant and investigators
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be conducted using a double-blind, placebo-controlled, parallel group design.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: March 29, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)