HealthyNCT06307275
Intermittent Fasting on Body Fat and Quality of Life
A study testing Fasting and non fasting in people with Healthy, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fasting and non fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good health
Who cannot join
- Diabetes or Metabolic Syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University
Loma Linda, California, 92350
Gurinder Bains, PhD, 909-558-4000 ext. 87274, gbains@llu.edu
About this study
Official title: The Effect of Intermittent Fasting on Body Fat and Quality of Life
The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.
Read the 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.
- Conditions
- Healthy
- Being tested
- Fasting, non fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
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.
non fastingOther
Participants will not be fasting during these four weeks. They will eat their normal food intake and keep their normal physical activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Non Fasting | Active comparator | 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. Receives: Other: non fasting |
| Fasting | Experimental | 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. Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat percentage
Body composition will give the following measurement: body fat percentage
Measured: change between baseline and eight weeks
Visceral fat
In addition, body composition will also give us visceral fat measurement
Measured: change between baseline and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start11 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gurinder Bains, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307275
- Sponsor's protocol ID
- 5170221
- Status last verified
- Apr 2026
- First submitted
- 29 Feb 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Fasting on Body Fat and Quality of Life
- ClinicalTrials.gov ID
- NCT06307275
- Acronym / sponsor ID
- 5170221
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Fasting | Active comparator | Other: non fastingFor four week: Participants will keep their normal food intake with no restrictions on when to eat. Participants will keep their normal weekly exercise routine. |
| Fasting | Experimental | Other: FastingFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In good health
Key exclusion criteria (1 listed)
- Diabetes or Metabolic Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingFasting 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. | Other | Fasting |
| non fastingParticipants will not be fasting during these four weeks. They will eat their normal food intake and keep their normal physical activity levels. | Other | Non Fasting |
Primary outcome
Body fat percentage
Time frame: change between baseline and eight weeks
Body composition will give the following measurement: body fat percentage
Visceral fat
Time frame: change between baseline and eight weeks
In addition, body composition will also give us visceral fat measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gurinder Bains, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and non fasting in people with Healthy, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gurinder Bains, PhD (909-558-4000 ext. 87274, gbains@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat percentage (time frame: change between baseline and eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.