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Ketogenic Diet in Healthy Adults With Differing BMI
Bu çalışma, farklı vücut kitle indeksine (BMI) sahip sağlıklı yetişkinlerde ketojenik diyetin etkilerini incelemektedir. Çalışmaya, 25-45 yaş arası, belirli sağlık ölçütlerini karşılayan sağlıklı yetişkinler dahil edilmiştir. Faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: 1. Age 25-45 years 2. Fasting direct LDL-C ≤100 mg/dL 3. BMI of 18.5-22 kg/m2 or 30-35 kg/m2 4. Blood pressure \<140/90 mmHg 5. Fasting blood glucose \<126 mg/dL 6. Fasting triglycerides \<350 mg/dL 7. ≤10% change in body weight for 6 months prior to enrollment Exclusion Criteria: 1. Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL 2. Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs 3. Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period 4. Diagnosed liver, kidney, or autoimmune disease 5. Prior cardiovascular event (e.g., stroke, heart attack) 6. Current pregnancy or intention of pregnancy within the next 2 months 7. Lactation within prior 6 months 8. Follows a vegetarian or vegan diet 9. Food allergies/intolerance/sensitives/dislikes of foods included in the study menu 10. Antibiotic use within the prior 1 month 11. Oral steroid use within the prior 1 month 12. Use of tobacco or nicotine containing products within the past 6 months 13. Cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence) 14. Participation in another clinical trial within 30 days of baseline 15. Currently following a restricted or weight loss diet 16. Previously consumed the ketogenic diet for more than 1 week 17. Prior bariatric surgery 18. Intake of \>14 alcoholic drinks/week and/or lack of willingness to consume no alcohol while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hours prior to test visits 19. Current or past eating disorder 20. Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements including being able to come to the metabolic kitchen to pick-up food five days per week 21. Planning to relocate out of the State College area in the next 2 months 22. Unwilling to refrain from plasma/blood donations during the study 23. Previously diagnosed familial hypercholesterolemia 24. If a potential participant takes thyroid medicine, abnormal thyroid stimulating hormone (TSH) concentration (TSH outside of normal range of 0.5 - 4.5 mIU/L)