Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323889
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-03-06
Brief Title:
Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Longitudinal Monitoring During Different Intermittent Fasting Protocols in Obese Adults - A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIMITFOOD2
Brief Summary:
LIMITFOOD2 is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of obese adults A total of 90 participants will be randomized into three equally sized groups a modified alternate day fasting a time-restricted eating and a control group receiving general weight-loss counseling
Detailed Description:
The prevalence of overweight and obesity worldwide has risen considerably in the past century with more than one billion overweight persons and about 600 million obese patients in 2015 Humans in modern societies typically eat at least three main meals per day and snacks around the clock This change in eating pattern in terms of quantity and frequency leads to overconsumption of food and consequently to excess weight Furthermore obesity increases the risk of developing diabetes cardiovascular disease and several types of cancer The world health organization WHO has stated that there are 28 million deaths per year as a result of overweight and obesity
In recent years the concept of re-introduced fasting intervals in the form of intermittent fasting IF protocols became a popular alternative dietary strategy with the aim to achieve weight control and improve metabolic health There are several different IF protocols the most popular is time-restricted eating TRE which allows ad libitum at ones pleasure energy intake within a defined time period each time 6 to 12 hours Another IF protocol is alternate day fasting ADF on feast days one can consume food ad libitum while on fast days no or little food is consumed feast and fast days alternate throughout the week Animal studies and previous human clinical trials have provided evidence that various types of IF lead to weight loss and improved health markers So far interventional studies focused on the comparison of IF versus a control group however only few studies compared different IF protocols directly Given both the evidence for beneficial effects of IF as well as its growing popularity it seems mandatory to reveal possible differences in the effectiveness of different protocols
The present project will allow to directly compare two types of IF with each other and with a control group in obese participants Furthermore established and novel monitoring tools to track individual progress during IF are scarcely used so far but may become an important help in the future and thus will be implemented in this trial
In recent years the concept of re-introduced fasting intervals in the form of intermittent fasting IF protocols became a popular alternative dietary strategy with the aim to achieve weight control and improve metabolic health There are several different IF protocols the most popular is time-restricted eating TRE which allows ad libitum at ones pleasure energy intake within a defined time period each time 6 to 12 hours Another IF protocol is alternate day fasting ADF on feast days one can consume food ad libitum while on fast days no or little food is consumed feast and fast days alternate throughout the week Animal studies and previous human clinical trials have provided evidence that various types of IF lead to weight loss and improved health markers So far interventional studies focused on the comparison of IF versus a control group however only few studies compared different IF protocols directly Given both the evidence for beneficial effects of IF as well as its growing popularity it seems mandatory to reveal possible differences in the effectiveness of different protocols
The present project will allow to directly compare two types of IF with each other and with a control group in obese participants Furthermore established and novel monitoring tools to track individual progress during IF are scarcely used so far but may become an important help in the future and thus will be implemented in this trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None