Fasting Mimicking Diet and Autophagy

Last updated: April 3, 2024
Sponsor: L-Nutra Inc
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Fasting Mimicking Diet

Clinical Study ID

NCT06115551
LNT22-017
  • Ages 25-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability and willingness to provide written informed consent;
  • Ability and willingness to perform the study tests and adhere to study protocol (tothe best of the participant's knowledge);
  • BMI 20-35 kg/m2 (inclusive) at screening;

Exclusion

Exclusion Criteria:

  • Diabetes treatment other than diet or metformin monotherapy;
  • History of gastric bypass;
  • Subjects with recent weight loss (>5%), use of weight loss medication, participated ina 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 threedrinks per day for men).
  • Has any medical disease or condition that, in the opinion of the principalinvestigator (PI) or appropriate study personnel, precludes study participation* (*Including acute, subacute, intermittent or chronic medical disease or condition thatwould place the subject at an unacceptable risk of injury, render the subject unableto meet the requirements of the protocol, or may interfere with the evaluation ofresponses or the subject's successful completion of this trial);

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Fasting Mimicking Diet
Phase:
Study Start date:
May 02, 2023
Estimated Completion Date:
April 30, 2024

Study 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 are caused by several molecular mechanisms, including the reduction of body weight, ectopic fat storage, insulin levels, endogenous glucose production and IGF-1. Autophagy is a catabolic membrane-trafficking phenomenon observed in yeast and mammalian cells. Nutrient deprivation induces autophagy. Autophagy has been proposed to be a fundamental cellular process being linked to aging and the progression of age-related diseases. The objective of this study is to evaluate the effects of consuming two FMD formulations on the autophagy process in the cell.

Connect with a study center

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.