Clinical Trials Directory

Trials / Completed

CompletedNCT03114176

Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox

Effects of Exercise and Dietary Inatke on Muscle Metabolism and Inflammatory Status Modulated by Oxygen Free Radicals and Cytokines in Humans

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Padova · Academic / Other
Sex
Male
Age
25 Years – 65 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKetogenic DietDiet 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.

Timeline

Start date
2016-05-25
Primary completion
2016-07-10
Completion
2016-07-10
First posted
2017-04-14
Last updated
2017-04-14

Source: ClinicalTrials.gov record NCT03114176. Inclusion in this directory is not an endorsement.