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NCT06891352Toboroz

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers - The SHIFT Study

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 17.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
180 (tervezett)
Első benyújtás
2025. márc. 12.
Kezdés
2025. jún. 2.
Elsődleges befejezés
2028. aug. 31.
Fő szponzor
Salk Institute for Biological Studies
Betegségek
Elhízás
NCT-szám
NCT06891352

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 180
  • 2025. jún. 2. és az elsődleges befejezés (2028. aug. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Use of medications that are known to cause weight loss such as SGLT2 inhibitors and GLP1 receptor agonists)
  • Change in medications that could impact study outcomes within the past 3 months
  • Uncontrolled psychiatric disorder including prior hospitalization

Más betegség

  • Type 1 Diabetes or Insulin-dependent Type 2 Diabetes.
  • Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse in the past 5 years.
  • Active treatment for inflammatory and/or rheumatologic disease
  • History of a major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack)
  • Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are acceptable)
  • History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (hypothyroidism on a stable dose of thyroid replacement therapy is allowed).
  • History of adrenal disease in the past 5 years
  • History of malignancy undergoing active treatment, except non-melanoma skin cancer, in the past 5 years
  • History of an eating disorder in the past 5 years
  • History of cirrhosis in the past 5 years
  • History of stage 4 or 5 chronic kidney disease or dialysis in the past 5 years
  • History of HIV/AIDs
  • History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators

Laborértékek

  • Fasting LDL cholesterol greater than 250 mg/dL

Egyéb

  • Insufficient dietary logging on the mCC app is defined as less than 7 of 14 days of baseline of dietary logging with a minimum of 2 items a day, at least 5 hours apart.
  • Use of sulfonylurea or insulin within the last 3 months (due to unknown safety with TRE)
  • BMI > 50 kg/m2
  • Change in weight of >4kg in the past 3 months
  • Women who are pregnant, breastfeeding, or are trying to become pregnant during the study period. If a participant becomes pregnant during the study, they will be excluded from continuing the study.
  • Systolic BP greater than 160 mmHg and/or diastolic BP greater than 110 mmHg at rest
  • Fasting triglycerides greater than 500g/dL
  • Frequent (more than 4) travel involving a time zone change of more than 3 hours over the 1-year study period
  • Prolonged leave from work (a continuous month or longer) during the study
  • Currently enrolled in weight-loss or weight-management program

Kiket keres a vizsgálat

  • Age: 18-70 years
  • BMI ≥ 25 kg/m2 (or ≥ 23 kg/m2 for Asian adults)
  • Own a smartphone (Apple iOS or Android OS)
  • Baseline eating window ≥ 14 h/day
  • Night shift nurses and nursing assistants who are working a 12-hour night shift at least 3 days/week.
  • Have been doing night shift work for at least 3 months.
  • Patients on cardiovascular medications (HMG CoA reductase inhibitors (statins), metformin, lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive, drugs), are allowed
  • If patients have Type 2 Diabetes, they will be included in the study if A1c is less than 9 and they are not on insulin.

Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
University of California, San Diego Altman Clinical and Translational Research InstituteLa JollaEgyesült ÁllamokToboroz

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