Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114176
• Other study ID #: NEPL-DSB 06/16
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 10, 2017
• Start date: May 25, 2016
• Est. completion date: July 10, 2016

Study information

• Verified date: April 2017
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 10, 2016
• Est. primary completion date: July 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative damage change	8-OH-dG (ng · mg-1 creatinine) and 8-iso-PGF2a (ng · mg-1 creatinine)	Change from Baseline Oxidative damage at twenty days
Primary	Pro-inflammatory cytokines change	IL-1ß (pg/ml), IL-6 (pg/ml) and TNF- a (pg/ml)	Change from Baseline Pro-inflammatory cytokines at twenty days
Secondary	Weight Loss	Kilogram (Kg)	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).