CompletedNot Applicable

The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response

Poland14 participantsStarted 2019-10-01

Plain-language summary

The subject of doctoral dissertation: Assessment of the effects of a meatless, ketogenic restrictive diet on body composition, strength capacity, oxidative stress and immune response During planning of research and topic of the doctoral dissertation, it was considered how to modify a standard ketogenic diet rich in saturated fatty acids so that the use of this model of nutrition has the most anti-inflammatory effect. Therefore, it was decided to conduct a research to check whether a diet rich in omega-3 polyunsaturated fatty acids will show such an effect when following a high-fat diet. Hypotheses: 1\. The ketogenic diet reduces systemic inflammation. 2.The ketogenic diet reduces oxidative stress. 3. The ketogenic diet reduces body fat. 4. A ketogenic diet does not worsen strength performance.

Who can participate

Age range

32 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male or female * healthy * age 32 - 59 * non-smoker * not abusing alcohol * not subjected to physical exercise for at least 48 hours before the examination Exclusion Criteria: * cardiovascular, * thyroid disease, * gastrointestinal, * respiratory * or any other metabolic diseases adherence to special diets, use of nutritional supplements and use of medication to control blood lipids or glucose

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Body composition

Timeframe: 2 weeks

Body weight

Timeframe: 2 weeks

TMAO

Timeframe: 2 weeks

Lipids level (TC, HDL, LDL, TG)

Timeframe: 2 weeks

glucose level (blood, urine)

Timeframe: 2 weeks

ketone bodies (blood, urine)

Timeframe: 2 weeks

inflammatory markers

Timeframe: 2 weeks

markers of oxidative stress 1

Timeframe: 2 weeks

Trial details

NCT IDNCT05558488

SponsorKatarzyna Siedzik

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Body Weight trials

Plain-language summary

Who can participate

Age range

32 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Body composition

Timeframe: 2 weeks

Body weight

Timeframe: 2 weeks

TMAO

Timeframe: 2 weeks

Lipids level (TC, HDL, LDL, TG)

Timeframe: 2 weeks

glucose level (blood, urine)

Timeframe: 2 weeks

ketone bodies (blood, urine)

Timeframe: 2 weeks

inflammatory markers

Timeframe: 2 weeks

markers of oxidative stress 1

Timeframe: 2 weeks