Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Weight-loss counseling

Modified Alternate Day Fasting

Time-Restricted Eating

Clinical Study ID

NCT06323889

LIMITFOOD2

Ages 18-50
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age between 18-50 years, both inclusive
Obese, BMI between 30 and 40 kg/m^2 (obesity grade I or II), both inclusive
Non-smoker
Good knowledge of German or English language
Stable weight change (change < +/- 3% current bodyweight) for 3 months prior to thestudy
HbA1c < 6.5% without glucose lowering medication
LDL-cholesterol < 4.6mmol/l without lipid lowering medication

Exclusion

Exclusion Criteria:

Participants who have a fasting period of > 12h per day on a regular basis and donot eat at least three main meals per day.
Current habitual use of dietary supplements (e.g., vitamins, minerals) and/orunwillingness to cease intake of dietary supplements.
Antibiotics intake during 3 months prior to the study due to possible interferencewith metabolic parameters
Food intolerances, allergies and sensitivities (severe food allergies) or dietaryrestrictions (e.g. vegan lifestyle)
Acute or chronic infections, malignant disease, renal, hepatic (more than two-foldincreased transaminases), pulmonary, neurological (epilepsy) or psychiatricdiseases, manifested atherosclerosis, or any other disease precluding participationin the study.
Diabetes
Known alcohol, substance or drug abuse, concomitant medication
More than four hours of physical exercise per week
Women who are pregnant, breast-feeding or aiming to become pregnant during course ofthe trial
Women and men on hormonal supplementation
Women with an irregular menstrual cycle according to the FIGO criteria
Therapy with antidepressants within the past 6 months
Regular therapy with acetylsalicyclic acid or current medication to regulate bloodsugar, blood pressure or lipids
Participants likely to fail to comply with the study protocol
Participants who do not give informed consent

Study Design

Weight-loss counseling

September 23, 2024

January 31, 2027

Study 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 2.8 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 one's 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.

Connect with a study center

Department of Endocrinology, Diabetology and Clinical Nutrition
Zürich, 8091
Switzerland
Active - Recruiting

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