Status:
ACTIVE_NOT_RECRUITING
Fasting Mimicking Diet and Autophagy
Lead Sponsor:
L-Nutra Inc
Collaborating Sponsors:
The University of Texas Health Science Center at San Antonio
Conditions:
Diet
Autophagy
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.
Detailed Description
Fasting-mimicking diet (FMD) was developed to mimic the endocrine and metabolic effects that water-only fasting, while providing a modest calories and essential nutrients. The health benefits of FMD a...
Eligibility Criteria
Inclusion
- Ability and willingness to provide written informed consent;
- Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
- BMI 20-35 kg/m2 (inclusive) at screening;
Exclusion
- Diabetes treatment other than diet or metformin monotherapy;
- History of gastric bypass;
- Subjects with recent weight loss (\>5%), use of weight loss medication, participated in a weight loss program in the past 3 months;
- Type 1 diabetes (based on medical history provided at screening);
- Use of immune suppression drugs;
- Contraindication for study foods (special food needs and allergy);
- Women who are pregnant;
- Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
- Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation\* (\*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);
Key Trial Info
Start Date :
May 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06115551
Start Date
May 2 2023
End Date
April 30 2024
Last Update
April 4 2024
Active Locations (1)
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1
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229