Overweight and ObesityNCT03114176
Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox
A study testing Ketogenic Diet in people with Overweight and Obesity and Exertion; Excess, run by University of Padova.
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Exertion; Excess, Oxygen Toxicity
- What is being tested?
- Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2016to 10 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be in an overweight state (BMI ≥ 25 kg/m2) and no history of orthopedic, cardiovascular, renal or metabolic disorders.
Who cannot join
- not to be in an overweight state (BMI ≥ 25 kg/m2) and a history of orthopedic, cardiovascular, renal or metabolic disorders.
About this study
Official title: Effects of Exercise and Dietary Inatke on Muscle Metabolism and Inflammatory Status Modulated by Oxygen Free Radicals and Cytokines in Humans
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
- Being tested
- Ketogenic Diet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Divers group | Experimental | 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] Receives: Dietary Supplement: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative damage change
8-OH-dG (ng ⋅ mg-1 creatinine) and 8-iso-PGF2α (ng ⋅ mg-1 creatinine)
Measured: Change from Baseline Oxidative damage at twenty days
Pro-inflammatory cytokines change
IL-1β (pg/ml), IL-6 (pg/ml) and TNF- α (pg/ml)
Measured: Change from Baseline Pro-inflammatory cytokines at twenty days
Secondary outcomes (1)
Weight Loss
Kilogram (Kg)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start25 May 2016
- Primary completion10 Jul 2016
- Study completion10 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Paoli, University of Padova
- Investigators
- Bosco Gerardo, MD, PhD, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114176
- Sponsor's protocol ID
- NEPL-DSB 06/16
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Dietary Inatke on Muscle Metabolism and Inflammatory Status Modulated by Oxygen Free Radicals and Cytokines in Humans
- ClinicalTrials.gov ID
- NCT03114176
- Acronym / sponsor ID
- NEPL-DSB 06/16
- Conditions
- Overweight and Obesity, Exertion; Excess, Oxygen Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 25 May 2016 (actual)
- Primary completion
- 10 Jul 2016 (actual)
- Study completion
- 10 Jul 2016 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Divers group | Experimental | Dietary Supplement: Ketogenic DietThroughout 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] |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- to be in an overweight state (BMI ≥ 25 kg/m2) and no history of orthopedic, cardiovascular, renal or metabolic disorders.
Key exclusion criteria (1 listed)
- not to be in an overweight state (BMI ≥ 25 kg/m2) and a history of orthopedic, cardiovascular, renal or metabolic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic 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. | Dietary supplement | Divers group |
Primary outcome
Oxidative damage change
Time frame: Change from Baseline Oxidative damage at twenty days
8-OH-dG (ng ⋅ mg-1 creatinine) and 8-iso-PGF2α (ng ⋅ mg-1 creatinine)
Pro-inflammatory cytokines change
Time frame: Change from Baseline Pro-inflammatory cytokines at twenty days
IL-1β (pg/ml), IL-6 (pg/ml) and TNF- α (pg/ml)
1 secondary outcome
Weight Loss
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bosco Gerardo, MD, PhD study director
University of Padova
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with Overweight and Obesity and Exertion; Excess, run by University of Padova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative damage change (time frame: Change from Baseline Oxidative damage at twenty days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.