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

NCT ID: NCT04807959

Last Updated: 2021-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-27

Study Completion Date

2018-10-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a retrospective, multi-center clinical study to evaluate the efficacy of the 20Lighter comprehensive anti-obesity program in reducing body composition measures including body weight, body fat, visceral adiposity, intracellular fluid, and other metrics of interest. Anecdotal evidence on reductions of prescription medication, chronic health issues, and improvements in quality of life will be gauged via review of patient assessment forms and surveys.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

20Lighter Program Participants

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

20Lighter anti-obesity program

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

20Lighter anti-obesity program

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

20Lighter

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jessica Barnes, PhD

Role: STUDY_CHAIR

20Lighter

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27272580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24222017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9813653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11684524 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26883276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24993615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23408502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23569168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27411588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27282289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23497604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25251676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27304506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25404320 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-443A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Body Weight and Vascular Function
NCT01675401 COMPLETED NA