Evaluation of the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program

NCT04807959 | Completed

• 1 other identifier: 2016-443A
• Study Type: observational
• Target: 2,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

A retrospective review of body composition outcomes of participants of a comprehensive visceral-fat focused anti-obesity program. Data from approximately 2000-2500 participants are expected to be included in the study.

Conditions

Obesity; Obesity, Morbid; Obesity, Visceral; Central Obesity; Metabolic Disease; Hypertension; Dyslipidemias; Type 2 Diabetes; Visceral Obesity

Outcome Measures

Primary Outcomes (1)

• Reduction of Visceral Adiposity

  % reduction of visceral adiposity (as measured by visceral fat rating) measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes.

  Change from baseline to program completion (60 Days)

Secondary Outcomes (4)

• Reduction of Body Weight

  Change from baseline to program completion (60 Days)

• Reduction of Body Mass Index

  Change from baseline to program completion (60 Days)

• Reduction of Body Fat

  Change from baseline to program completion (60 Days)

• Increase of Intracellular Fluid

  Change from baseline to program completion (60 Days)

Study Arms (1)

20Lighter Program Participants

All enrolled subjects will have completed a 20Lighter anti-obesity program prior to enrollment.

Other: 20Lighter anti-obesity program

Interventions

20Lighter anti-obesity program OTHER

A customized expert supervised 3-phase program including non-invasive proprietary nutritional, behavioral, and physiological components.

20Lighter Program Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults over the age of 18 with overweight or obesity, and may have other comoribid conditions including hypertension, type 2 diabetes, dyslipidemia, cardiovascular disease (CVD), nonalcoholic fatty liver disease, sleep apnea, and other related health issues.

You may qualify if:

• BMI \>25
• ability to stand on platform for body composition analysis

You may not qualify if:

• Pregnant at time of enrollment
• Breastfeeding at time of enrollment
• Undergoing treatment for cancer at time of enrollment
• History of major organ transplant with immunosuppressant medication
• Over the 70 years of age with diagnosis of three cardiovascular comorbidities at time of enrollment
• Adult with a vegetarian diet
• Diagnosis of psychiatric conditions including: schizophrenia, bipolar disorder, manic depression

Sponsors & Collaborators

• 20Lighter: lead

Related Publications (14)

• Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.

  PMID: 27272580 BACKGROUND

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available.

  PMID: 24222017 BACKGROUND

• Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.

  PMID: 9813653 BACKGROUND

• Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579.

  PMID: 11684524 BACKGROUND

• Balasubramanian P, Longo VD. Growth factors, aging and age-related diseases. Growth Horm IGF Res. 2016 Jun;28:66-8. doi: 10.1016/j.ghir.2016.01.001. Epub 2016 Jan 7.

  PMID: 26883276 BACKGROUND

• Barnosky AR, Hoddy KK, Unterman TG, Varady KA. Intermittent fasting vs daily calorie restriction for type 2 diabetes prevention: a review of human findings. Transl Res. 2014 Oct;164(4):302-11. doi: 10.1016/j.trsl.2014.05.013. Epub 2014 Jun 12.

  PMID: 24993615 BACKGROUND

• Bhutani S, Klempel MC, Kroeger CM, Trepanowski JF, Varady KA. Alternate day fasting and endurance exercise combine to reduce body weight and favorably alter plasma lipids in obese humans. Obesity (Silver Spring). 2013 Jul;21(7):1370-9. doi: 10.1002/oby.20353. Epub 2013 May 29.

  PMID: 23408502 BACKGROUND

• Collier R. Intermittent fasting: the science of going without. CMAJ. 2013 Jun 11;185(9):E363-4. doi: 10.1503/cmaj.109-4451. Epub 2013 Apr 8. No abstract available.

  PMID: 23569168 BACKGROUND

• Di Biase S, Lee C, Brandhorst S, Manes B, Buono R, Cheng CW, Cacciottolo M, Martin-Montalvo A, de Cabo R, Wei M, Morgan TE, Longo VD. Fasting-Mimicking Diet Reduces HO-1 to Promote T Cell-Mediated Tumor Cytotoxicity. Cancer Cell. 2016 Jul 11;30(1):136-146. doi: 10.1016/j.ccell.2016.06.005.

  PMID: 27411588 BACKGROUND

• Dorff TB, Groshen S, Garcia A, Shah M, Tsao-Wei D, Pham H, Cheng CW, Brandhorst S, Cohen P, Wei M, Longo V, Quinn DI. Safety and feasibility of fasting in combination with platinum-based chemotherapy. BMC Cancer. 2016 Jun 10;16:360. doi: 10.1186/s12885-016-2370-6.

  PMID: 27282289 BACKGROUND

• Eshghinia S, Mohammadzadeh F. The effects of modified alternate-day fasting diet on weight loss and CAD risk factors in overweight and obese women. J Diabetes Metab Disord. 2013 Jan 9;12(1):4. doi: 10.1186/2251-6581-12-4.

  PMID: 23497604 BACKGROUND

• Hoddy KK, Kroeger CM, Trepanowski JF, Barnosky A, Bhutani S, Varady KA. Meal timing during alternate day fasting: Impact on body weight and cardiovascular disease risk in obese adults. Obesity (Silver Spring). 2014 Dec;22(12):2524-31. doi: 10.1002/oby.20909. Epub 2014 Sep 24.

  PMID: 25251676 BACKGROUND

• Longo VD, Panda S. Fasting, Circadian Rhythms, and Time-Restricted Feeding in Healthy Lifespan. Cell Metab. 2016 Jun 14;23(6):1048-1059. doi: 10.1016/j.cmet.2016.06.001.

  PMID: 27304506 BACKGROUND

• Mattson MP, Allison DB, Fontana L, Harvie M, Longo VD, Malaisse WJ, Mosley M, Notterpek L, Ravussin E, Scheer FA, Seyfried TN, Varady KA, Panda S. Meal frequency and timing in health and disease. Proc Natl Acad Sci U S A. 2014 Nov 25;111(47):16647-53. doi: 10.1073/pnas.1413965111. Epub 2014 Nov 17.

  PMID: 25404320 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Obesity, Abdominal; Metabolic Diseases; Hypertension; Dyslipidemias; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Jessica Barnes, PhD

  20Lighter

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: October 27, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 9, 2018
• Last Updated: March 22, 2021

Record last verified: 2021-03