Gastrointestinal Hormonal Regulation of Obesity

NCT01146704 | Completed Results

• 1 other identifier: F7219-R
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.

• Safety Variables: Incidence, Severity and Duration of Adverse Events, Vital Signs, Concomitant Medications and Physical Examination Results.

  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.

• Improvement in NAFLD Fibrosis Score

  1 year

Study Arms (2)

Standard Diet

ACTIVE COMPARATOR

Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.

Dietary Supplement: Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass

High Protein Diet

ACTIVE COMPARATOR

High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.

Dietary Supplement: Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate

Interventions

Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass DIETARY_SUPPLEMENT

Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.

Also known as: Standard Protein Diet

Standard Diet

Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate DIETARY_SUPPLEMENT

High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.

Also known as: High Protein Diet

High Protein Diet

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (4)

• Wang L, Jacobs JP, Lagishetty V, Yuan PQ, Wu SV, Million M, Reeve JR Jr, Pisegna JR, Tache 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.

  PMID: 28724546 BACKGROUND

• 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.

  PMID: 29070713 BACKGROUND

• Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Tache 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.

  PMID: 23883680 BACKGROUND

• 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.

  PMID: 26336928 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Proteins; Carbohydrates; Diet, High-Protein

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Joseph Pisegna
• Organization: Department of Veterans Affairs, VAGLAHS

Joseph.Pisegna@va.gov

3104783711

Study Officials

• Joseph R Pisegna, MD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: June 17, 2010
• Study Start: September 1, 2010
• Primary Completion: December 31, 2018
• Study Completion: February 27, 2019
• Last Updated: February 4, 2025
• Results First Posted: February 10, 2020

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)