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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03114176
Other study ID # NEPL-DSB 06/16
Secondary ID
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
Health authority
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.

Study Design


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).
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