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Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox

Primary Purpose

Overweight and Obesity, Exertion; Excess, Oxygen Toxicity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketogenic Diet
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Divers group

    Arm Description

    Throughout each dive, subjects performed a 20-minute long mild exercise on an underwater bike. The depth of dive was set at 15 meters, where the subjects performed an activity guided by Borg CR-10 scale at intensity level 3 (25 rpm). The ascent rate was set at 10 m/min, with a decompression stop at 5 meters for 3 min, according to the US Navy Manual Diving Table. 48 h prior to the immersions, none of the participants consumed medications or dived or flew. In the first part of the experiment, all subjects performed a dive breathing Enriched Air Nitrox (EAN, 32% ppO2). Baseline clinical measurements were collected before and after this first dive in order to have a reference [CTRL] and to measure physiological modifications due to immersion [NTRX]. After twenty days of no diving activity, subjects were engaged in a KD for seven days. At the end of this period, subjects performed a single immersion breathing EAN. The measures were performed after this single dive [KETO-NTRX]

    Outcomes

    Primary Outcome Measures

    Oxidative damage change
    8-OH-dG (ng ⋅ mg-1 creatinine) and 8-iso-PGF2α (ng ⋅ mg-1 creatinine)
    Pro-inflammatory cytokines change
    IL-1β (pg/ml), IL-6 (pg/ml) and TNF- α (pg/ml)

    Secondary Outcome Measures

    Weight Loss
    Kilogram (Kg)

    Full Information

    First Posted
    April 4, 2017
    Last Updated
    April 10, 2017
    Sponsor
    University of Padova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03114176
    Brief Title
    Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox
    Official Title
    Effects of Exercise and Dietary Inatke on Muscle Metabolism and Inflammatory Status Modulated by Oxygen Free Radicals and Cytokines in Humans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 25, 2016 (Actual)
    Primary Completion Date
    July 10, 2016 (Actual)
    Study Completion Date
    July 10, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Padova

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity, Exertion; Excess, Oxygen Toxicity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Divers group
    Arm Type
    Experimental
    Arm Description
    Throughout each dive, subjects performed a 20-minute long mild exercise on an underwater bike. The depth of dive was set at 15 meters, where the subjects performed an activity guided by Borg CR-10 scale at intensity level 3 (25 rpm). The ascent rate was set at 10 m/min, with a decompression stop at 5 meters for 3 min, according to the US Navy Manual Diving Table. 48 h prior to the immersions, none of the participants consumed medications or dived or flew. In the first part of the experiment, all subjects performed a dive breathing Enriched Air Nitrox (EAN, 32% ppO2). Baseline clinical measurements were collected before and after this first dive in order to have a reference [CTRL] and to measure physiological modifications due to immersion [NTRX]. After twenty days of no diving activity, subjects were engaged in a KD for seven days. At the end of this period, subjects performed a single immersion breathing EAN. The measures were performed after this single dive [KETO-NTRX]
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ketogenic Diet
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Oxidative damage change
    Description
    8-OH-dG (ng ⋅ mg-1 creatinine) and 8-iso-PGF2α (ng ⋅ mg-1 creatinine)
    Time Frame
    Change from Baseline Oxidative damage at twenty days
    Title
    Pro-inflammatory cytokines change
    Description
    IL-1β (pg/ml), IL-6 (pg/ml) and TNF- α (pg/ml)
    Time Frame
    Change from Baseline Pro-inflammatory cytokines at twenty days
    Secondary Outcome Measure Information:
    Title
    Weight Loss
    Description
    Kilogram (Kg)
    Time Frame
    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).

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bosco Gerardo, MD, PhD
    Organizational Affiliation
    University of Padova
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox

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