Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox

Not Applicable

Completed

• Conditions: Overweight and Obesity; Oxygen Toxicity; Exertion; Excess

• Registration Number: NCT03114176
• Lead Sponsor: University of Padova

Brief Summary

Overweight divers face a challenging activity such as immersions, starting from a higher levels of circulating cytokines and oxidative stress. Ketogenic Diet (KD) is described as effective in weight loss, in countering inflammation and oxidative stress, and used in the control of drug-refractory seizures.

The aim of our pilot study was to evaluate if a ketosis state induced by a specific dietary regime, may have a protective effect on oxidative stress damages and inflammatory status, that accompanies both overweight and diving activities.

Blood and urine samples from six overweight divers were obtained a) before (CTRL) and after a dive breathing Enriched Air Nitrox and performing light underwater exercise (NTRX), b) after a dive (same conditions) performed after 7 days of KD (K-NTRX). We measured urinary 8-isoprostane and 8-OH-2-deoxyguanosine evaluating lipids peroxidation and DNA oxidative damages. Plasmatic IL-1beta, IL-6 and TNF-alpha levels were measured to investigate the inflammatory status.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-25
• Primary Completion: 2016-07-10
• Study Completion: 2016-07-10
• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• to be in an overweight state (BMI ≥ 25 kg/m2) and no history of orthopedic, cardiovascular, renal or metabolic disorders.

Exclusion Criteria

• not to be in an overweight state (BMI ≥ 25 kg/m2) and a history of orthopedic, cardiovascular, renal or metabolic disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Oxidative damage change	Change from Baseline Oxidative damage at twenty days	8-OH-dG (ng ⋅ mg-1 creatinine) and 8-iso-PGF2α (ng ⋅ mg-1 creatinine)
Pro-inflammatory cytokines change	Change from Baseline Pro-inflammatory cytokines at twenty days	IL-1β (pg/ml), IL-6 (pg/ml) and TNF- α (pg/ml)

Secondary Outcome Measures

Name	Time	Method
Weight Loss	Weight was registered before (T0) and after twenty days of no diving activity in which subjects were engaged in a 7-days Ketogenic Diet (T3).	Kilogram (Kg)