NCT06307275

Brief Summary

The purpose of this investigator-initiated study to check the feasibility that intermittent fasting has on body fat loss and quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
7mo left

Started Mar 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

February 29, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

February 29, 2024

Last Update Submit

April 30, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Body fat percentage

    Body composition will give the following measurement: body fat percentage

    change between baseline and eight weeks

  • Visceral fat

    In addition, body composition will also give us visceral fat measurement

    change between baseline and eight weeks

Study Arms (2)

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.

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.

Other: Fasting

Interventions

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.

Fasting
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.

Non Fasting

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In good health

You may not qualify if:

  • Diabetes or Metabolic Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Interventions

Angptl4 protein, mouse

Study Officials

  • Gurinder Bains, PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gurinder Bains, PhD

CONTACT

909-558-4000gbains@llu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 12, 2024

Study Start

March 11, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

US(1)