- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06307275
Intermittent Fasting on Body Fat and Quality of Life
The Effect of Intermittent Fasting on Body Fat and Quality of Life
Study Overview
Detailed Description
Start of study: Informed Consent, Body Fat Analysis, Questionnaires on quality of life, sleep, and stress. For the next four weeks, participants will eat their normal food intake with no restrictions on when to eat. Participants will keep their normal weekly exercise routine.
Midway of study: Body Fat Analysis, Questionnaires on quality of life, sleep, and stress. For the next four weeks, participants will do the intermittent fasting program. This program has participants fasting 16 hours from their last meal of the previous evening's meal to the first meal of their next day. Then for 8 hours, participants are able to eat. During the fasting, participants are allowed to consume water and black coffee/tea. Participants will also keep their normal weekly exercise routine.
End of study: Body Fat Analysis, Questionnaires on quality of life, sleep, and stress.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gurinder Bains, PhD
- Phone Number: 87274 909-558-4000
- Email: gbains@llu.edu
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Recruiting
- Loma Linda University
-
Contact:
- Gurinder Bains, PhD
- Phone Number: 87274 909-558-4000
- Email: gbains@llu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• In good health
Exclusion Criteria:
• Diabetes or Metabolic Syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Non Fasting
For four week: Participants will keep their normal food intake with no restrictions on when to eat.
Participants will keep their normal weekly exercise routine.
|
Participants will not be fasting during these four weeks.
They will eat their normal food intake and keep their normal physical activity levels.
|
|
Experimental: Fasting
For four weeks: Fasting for 16 hours from participant last meal of the previous evening's meal to the first meal of the next day.
Then for 8 hours, participant is able to eat.
During the fasting, participants are allowed to consume water and black coffee/tea.
Participants will also keep their normal weekly exercise routine.
|
Fasting for 16 hours from participant last meal of the previous evening's meal to the first meal of the next day.
Then for 8 hours, participant is able to eat.
During the fasting, participants are allowed to consume water and black coffee/tea.
Participants will also keep their normal weekly exercise routine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body fat percentage
Time Frame: change between baseline and eight weeks
|
Body composition will give the following measurement: body fat percentage
|
change between baseline and eight weeks
|
|
Visceral fat
Time Frame: change between baseline and eight weeks
|
In addition, body composition will also give us visceral fat measurement
|
change between baseline and eight weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gurinder Bains, PhD, Loma Linda University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5170221
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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