Heart Obesity Prevention Education

NCT02092545 | Completed

• 1 other identifier: TGH0002
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Study to collect data on weight management on a male population of retired NFL athletes.

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body mass index from start of study in 6 month timeframe.

  Calculate change in weight and BMI

  6 months

Study Arms (1)

Ketogenic diet

OTHER

Weight management on a male population of retired NFL athletes.

Other: Ketogenic diet

Interventions

Ketogenic diet OTHER

Also known as: High protein, Low carbohydrate

Ketogenic diet

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males
• Former NFL players
• Aged 25-64 (Age range is chosen to keep participants as uniform as possible given the small number of participants. The majority of the players are in this age range and participants need to be able to exercise and be active. Also the NFL in its current form was created in 1970 so there are very few players that are retired from the NFL that are over the age of 65.)
• BMI \>27
• English- speaking

You may not qualify if:

• Cancer within the last 5 years (except non-melanoma skin cancer)
• Significant Cardiovascular Disease (recent \< 1 year Myocardial Infarction, hospital admission \< 1year for Congestive Heart Failure, Active Angina, exercise induced Angina)
• Malignant arrhythmias (VTACH, AFIB, Aflutter)
• Renal Disease ( Dialysis or Chronic Renal Insufficiency)
• Hepatic Disease ( Hepatitis B and C or Liver function test 2.5 times the upper limits of normal, or liver transplant that requires immune odulating/suppressing medications, ammonia lowering medications, or hepatic disease related to diet modification).
• Psychosis, Severe Anxiety, or Major Depression
• Significant migraines requiring abortive medication in the last year
• Significant Endocrine dysfunction ( Cushing's Syndrome )
• Uncontrolled Hypertension \> 160/90
• Severe arthritis that significantly limits mobility
• Uncontrolled Hyper/Hypothyroidism
• Obesity Surgery in the past
• Weight loss of greater than 10% of the subjects body weight in the last year
• Recent history (within 1 year ) of Alcohol abuse, illegal Drug abuse
• Active pulmonary disease that requires daily corticosteroids, an oxygen requirement, or ventilation support for chronic disease management.

Sponsors & Collaborators

• Tampa General Hospital: lead

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• John Gonzalvo, DO

  Tampa General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 20, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)