Obesity Clinical Trial
Official title:
Gastrointestinal Hormonal Regulation of Obesity
Verified date | March 2021 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to test and determine whether a high protein diet is efficacious, safe and beneficial to curtail food intake and body weight in obese adult human patients and to establish whether neurohormonal mechanisms of a high protein diet induce an early signal of fullness or satiety in a relevant experimental model, focusing on activation of gastric vagal afferents.
Status | Completed |
Enrollment | 31 |
Est. completion date | February 27, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: For inclusion in the study, patients must fulfill all of the following criteria: - Subjects must be able to attend all 7 scheduled study visits at the West LA GI clinic at the VAGLAHS, not including the screening visit. - Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization. - Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations. After the Informed Consent process, these additional Inclusion Criteria will be applied to potential subjects: - Age 30 years and older at screening. - BMI of 27 to 40 kg/m2 inclusive. - Subjects must be in good health as determined by medical history, physical examination performed by the Investigator (Study doctor) at the Screening stage, and screening clinical laboratory tests including chemistry panel and CBC. - Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study. - Subjects requiring the regular use of any prescription medication may be admitted to the study, providing the dose is stable. - Subjects must be able to communicate and cooperate with the Principal Investigator and the staff and willing to comply with the study instructions. Exclusion Criteria: - Weight instability: Subjects reporting weight change of greater than 3.0 kg in the month prior to screening. - Any subject who has been on a very low calorie diet (less than 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost greater than 10 kg in the 6 months prior to screening. - Any subject who has a history of diabetic gastroparesis or gastric emptying disorder as indicated in the potential subject's medical history and VA's Computer Patient Record System (CPRS). - Use of any other investigational drug(s) within 8 weeks prior to screening. - Subjects should not have received antibiotics within the prior 4 weeks of screening. - Abnormal laboratory parameters: - Serum creatinine greater than 1.6 mg/dL; - Liver function tests, alanine transaminase (ALT), alanine transaminase (AST), Bilirubin results greater than 2.0 times the upper limit of normal; - Triglycerides greater than 500 mg/dL; - Total cholesterol greater than 350 mg/dL; - Thyroid-stimulating hormone (TSH) outside of normal range disorder, as indicated in the potential subject's medical history, the VA's Computer Patient Record System (CPRS) and laboratory tests performed during the screening process. - Subjects who drink more than 1 alcoholic beverage per day (that is: 1 beer; or 1 glass of wine; or 1 shot of liquor). - Pregnant women or women likely to become pregnant during the course of the study may not participate in this study. Female subjects must not be able to conceive by reason of surgery, radiation, one year past the onset of menopause, or an approved method of contraception. - No vulnerable subjects will be included in the study. |
Country | Name | City | State |
---|---|---|---|
United States | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Taché Y. High-protein diet selectively reduces fat mass and improves glucose tolerance in Western-type diet-induced obese rats. Am J Physiol Regul Integr Comp Physiol. 2013 Sep 15;305(6):R582-91. doi: 10.1152/ajpregu.00598.2012. Epub 2013 Jul 24. — View Citation
Vu JP, Goyal D, Luong L, Oh S, Sandhu R, Norris J, Parsons W, Pisegna JR, Germano PM. PACAP intraperitoneal treatment suppresses appetite and food intake via PAC1 receptor in mice by inhibiting ghrelin and increasing GLP-1 and leptin. Am J Physiol Gastrointest Liver Physiol. 2015 Nov 15;309(10):G816-25. doi: 10.1152/ajpgi.00190.2015. Epub 2015 Sep 3. — View Citation
Vu JP, Luong L, Parsons WF, Oh S, Sanford D, Gabalski A, Lighton JR, Pisegna JR, Germano PM. Long-Term Intake of a High-Protein Diet Affects Body Phenotype, Metabolism, and Plasma Hormones in Mice. J Nutr. 2017 Dec;147(12):2243-2251. doi: 10.3945/jn.117.257873. Epub 2017 Oct 25. — View Citation
Wang L, Jacobs JP, Lagishetty V, Yuan PQ, Wu SV, Million M, Reeve JR Jr, Pisegna JR, Taché Y. High-protein diet improves sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity in rats. Am J Physiol Regul Integr Comp Physiol. 2017 Oct 1;313(4):R473-R486. doi: 10.1152/ajpregu.00105.2017. Epub 2017 Jul 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Weight From Baseline to 12 Months | The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard diet. | The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject. | |
Secondary | Efficacy Variables: Nutrition Assessments (FFQ, 3DFR, and Satiety Questionnaire), Anthropometric Profiles (e.g., Waist and Hip Circumferences), Lab and Biochemical Variables (e.g., Insulin, Lipid Levels, HbA1c), Body Composition (Body Fat), Hormone Level | High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity | The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject. | |
Secondary | Safety Variables: Incidence, Severity and Duration of Adverse Events, Vital Signs, Concomitant Medications and Physical Examination Results. | High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity | Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject. | |
Secondary | Improvement in NAFLD Fibrosis Score | Patients enrolled with a history of NAFLD will be assessed for improvement in NAFLD Fibrosis scoring index and other imaging parameters if performed as standard clinical care. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |