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Completed

NCT Number: NCT04732130

Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults

LIMITFOOD 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 normal- and overweight adults. A total of 72 participants will be randomized into three equally sized groups: an alternate day fasting, a time-restricted feeding and a control group.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology, Diabetology and Clinical Nutrition

Zurich, 8091, Switzerland

About this study

The prevalence of overweight has risen considerably all over the world in the past century. Epidemiological studies have shown that, starting from a body mass index of 20-21 kg/m2, increasing BMI levels are associated with progressively increased risks of developing diabetes, cardiovascular disease, several types of cancer and other diseases. The problem is pronounced by the unlimited and constant availability of food. Treatment of overweight is still difficult and finding effective and more personalized strategies to manage these conditions is crucial.

Intermittent fasting has been suggested as an alternative way to address these problems. Intermittent fasting is an eating pattern that involves rotating periods of eating and fasting. Animal studies and previous human clinical trials have provided evidence that various types of intermittent fasting lead to weight loss and improved health markers not only in obese, but also in healthy, non-obese adults.There are several types of intermittent fasting. The most popular version is time-restricted feeding (TRF), which allows ad libitum (at one's pleasure) energy intake within a defined period of time each day (6-12h). Another subtype of IF is called alternate day fasting (ADF). ADF is defined as 'feast days' on which food is consumed ad libitum, which alternate with 'fast days' on which food is withheld or reduced.

However, despite the growing popularity of intermittent fasting, it is not clear which type of IF is most effective and what fasting window is needed to induce beneficial effects. Additionally, tools to longitudinally track personal progress of dieting are lacking. Therefore, the main objective of this study is to compare the effects of each of two different intermittent fasting protocols (TRF and ADF) on metabolic parameters to a control group. Furthermore, a new dynamic measurement technique, using breath analysis, will allow to better monitor the progress of individual participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-40 years, both inclusive
  • Non-obese, BMI between 23 and 30 kg/m2, both inclusive
  • Non-smoker
  • Good knowledge of German or English language
  • Stable weight change (change < +/- 10% current bodyweight) for 3 months prior to the study
  • Glycohemoglobin (HbA1c) < 5.7% without glucose lowering medication
  • LDL-cholesterol < 180 mg/dl without lipid lowering medication
  • Blood pressure < 140/90 mmHG without blood pressure lowering medication

Exclusion criteria

  • Subjects who have a fasting period of > 12h per day on a regular basis and do not eat at least three main meals per day.
  • Current habitual use of dietary supplements (e.g. vitamins, minerals) and/or unwillingness to cease intake of dietary supplements.
  • Antibiotics intake during 3 months prior to the study
  • Food intolerances, allergies and sensitivities (e.g. lactose/gluten intolerance, food allergies) or dietary restrictions (e.g. vegan lifestyle)
  • Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in 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 of the trial
  • Women and men on hormonal supplementation
  • Women with a very irregular menstrual cycle
  • Therapy with antidepressants within the past 6 months
  • Regular therapy with acetylsalicyclic acid or current medication to regulate blood sugar, blood pressure or lipids
  • Subjects likely to fail to comply with the study protocol
  • Subjects who do not give informed consent

Treatment and study plan

Time-restricted feeding

Behavioral

Participants are instructed to limit food intake to maximum 8 hours per day.

Alternate Day Fasting

Behavioral

Participants are instructed to fast every other day.

Primary outcomes

  1. Fat mass

    Time frame: 4 weeks

    Change in whole body fat mass

Secondary outcomes

  1. Continuous glucose monitoring (CGM)

    Time frame: 4 weeks

    During the study period the CGM system will measure the continuous glucose concentration of the participants and thereby any changes will be measured.

  2. Physical activity energy expenditure

    Time frame: 4 weeks

    Change in mean physical activity energy expenditure will be recorded using an Actiheart monitor during the intervention.

  3. Resting metabolic rate (measured by indirect calorimetry)

    Time frame: 4 weeks

    Change in resting metabolic rate

Sponsors and collaborators

Lead sponsor

Philipp Gerber

Other

Registry information

Official study title

Longitudinal Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults - A Randomized Clinical Trial

Acronym: LIMITFOOD

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2021
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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