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Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox

NCT03114176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-04-14

No results posted yet for this study

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.

Conditions

  • Overweight and Obesity
  • Exertion; Excess
  • Oxygen Toxicity

Interventions

DIETARY_SUPPLEMENT

Ketogenic Diet

Diet consisted of a very low carbohydrate ketogenic diet (for 7 days) with the use of some phytoextracts as previously described. The consumed diet was primarily made of beef and veal, poultry, fish, raw and cooked green vegetables without restrictions, cold cuts (dried beef, carpaccio and cured ham), eggs and seasoned cheese (e.g., parmesan). The allowed drinks were infused tea, moka coffee and herbal extracts. The foods and drinks that subjects had to avoid included alcohol, bread, pasta, rice, milk, yogurt, soluble tea, and barley coffee. To facilitate adherence to the nutritional regime, a variety of special meals based on protein and fibers were given to each subject. KD characteristics are protein intake 1.3g/kg/day, to maintain skeletal muscle mass; carbohydrates intake less than 40 g/day and 50-60% of total kcal to induce ketosis. In accordance with a hypocaloric profile, total energy intake was calculated with 200 kcal more than basal metabolic rate.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Bosco Gerardo, MD, PhD · University of Padova

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-25
Primary Completion
2016-07-10
Completion
2016-07-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114176 on ClinicalTrials.gov