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Impact of Early Time Restricted Feeding with or without Multimodal Exercise on Type 2 Diabetes Risk Factors

Impact of Early Time Restricted Feeding with or without Multimodal Exercise on Type 2 Diabetes Risk Factors in At-Risk Adults.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000807853
Enrollment
26
Registered
2021-06-25
Start date
2022-11-28
Completion date
2023-08-25
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to determine to what extent early time restricted feeding with or without multimodal exercise improves metabolic health and reduces the risk of developing Type 2 Diabetes. Hypothesising that those within the early time restricted feeding plus exercise group will have more pronounced metabolic health benefits over those in the early time restricted feeding intervention alone. Additionally, the secondary purpose of the study is to determine whether either early time restricted feeding with or without exercise will induce a shift in circadian rhythm, hypothesising that both groups will induce a shift in circadian rhythm.

Interventions

Study Design: Potential Participants will be initially screened by the primary investigator. Successful applicants will then be invited to the Exercise Physiology Clinic at Murdoch University for the collection of preliminary baseline measurements following the attainment of written informed consent. This study will adopt a two-week Randomised Controlled Trial design with participants randomly allocated to an Early Time Restricted Feeding intervention either with or without Multimodal Exercise.

Study Design: Potential Participants will be initially screened by the primary investigator. Successful applicants will then be invited to the Exercise Physiology Clinic at Murdoch University for the collection of preliminary baseline measurements following the attainment of written informed consent. This study will adopt a two-week Randomised Controlled Trial design with participants randomly allocated to an Early Time Restricted Feeding intervention either with or without Multimodal Exercise. A two-week control period which will involve all participants will proceed prior to randomisation and allocation to assess the outcome measures for the study. Procedure: Participants from both groups will be required to complete the Early Time Restricted Feeding protocol. This will last for the duration of the intervention period (2-weeks). Throughout this 2-week time period, participants will be required to eat within an 8-hour feeding window prior to a >5-hour fasting period prior to sleep. Participants will be encouraged to maintain a similar dietary regime during the study to which they would normally eat in a regular day-to-day basis, inclusive of their diet and caloric intake. This information will be delivered in person at Murdoch University by the primary investigator, a newly graduated exercise physiologist. Those randomly allocated to the Early Time Restricted Feeding WITH Multimodal Exercise group will have to complete multimodal exercise in addition to completing the Early Time Restricted Feeding protocol. This Exercise program will occur in the >5-hour fasting window after eating and prior to sleep. The exercise intervention will occur on 12 of the 14 day intervention period for roughly 1-hour 30 mins each session. The Exercise Intervention will consist of Face-to-Face gym sessions and online Telehealth sessions via Microsoft Teams; all monitored by the primary investigator; an exercise physiologist. A familiarisation session will occur prior to day 1 of the intervention to educate participants on correct movement patterns and intensity of all exercises. The first 2 days and the last day of the 14 day intervention will consist of Face-to-Face gym sessions at Murdoch University to aid in the correction exercise technique and educating exercise intensity, while also providing the participants with a briefing/debriefing opportunity. As this study looks at real life implementation, the participants are free to decide how they would like to implement the remaining 11 days of the intervention, which will consist of 6 Telehealth sessions, 3 face-to-face gym sessions and 2 rest days. Additionally, face-to-face gym sessions will alternate between a session 1 (bench press, leg press, strict overhead press, leg extensions and triceps push downs) and session 2 (lat pull-downs, trap-bar dead-lifts, single arm cable rows, leg curls and biceps curls) to exercise all areas of the body. Telehealth exercises will include: sit-to-stands, counter-top push-ups, lunges, glute bridges and high plank holds. Participants will be required to complete 3x10 sets x repetitions for all gym exercises with a resistance weight to elicit 4-5 repetitions remaining for each set. Similarly for online Telehealth sessions, participants will be required to complete as many repetitions as needed to elicit 4-5 repetitions remaining for each set, completing 3 sets. All the above resistance exercises will need to be completed at a moderate-high intensity. This will be decided on a 1-10 scale, where 6/10 elicits the 4-5 repetition remaining required, visual referencing will be used for participants as well. Participants will also have to complete 30 minutes of aerobic exercise (walking) each exercise session; treadmill optional. This aerobic exercise will need to be completed in a moderate to high intensity (14/20 RPE). The exercise program will be administered in either a one-on-one setting or in a group setting, this depends on what days the participants will attend the face-to-face gym sessions and at what time they are attending depending on their own specific Early Time Restricted Feeding Protocol. Additionally, as adherence to the study is key, a session attendance checklist will be developed for each participant, allowing for close monitoring of the participants and how they are progressing with their sessions.

Sponsors

Murdoch University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Age greater and/or equal to 18 BMI greater and/or equal to 27 Physical activity <90mins per week.

Exclusion criteria

Currently taking insulin Currently using specific contraceptives (Implanon, Mirena IUD, the Pill Tobacco smoking 2 or more standard drinks of alcohol per day Prior/present: Heart, Lung, Kidney, Liver, Endocrine Disease Currently work night shift Currently diabetic

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026