Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults

NCT04732130 | Completed

• 1 other identifier: LIMITFOOD
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intermittent Fasting; Overweight; Time Restricted Feeding

Outcome Measures

Primary Outcomes (1)

• Fat mass

  Change in whole body fat mass

  4 weeks

Secondary Outcomes (3)

• Continuous glucose monitoring (CGM)

  4 weeks

• Physical activity energy expenditure

  4 weeks

• Resting metabolic rate (measured by indirect calorimetry)

  4 weeks

Study Arms (3)

Time-Restricted Feeding

ACTIVE COMPARATOR

Participants in the time-restricted feeding are instructed to eat ad libitum from 12:00 to 20:00 daily, and fast from 20:00 to 12:00 daily for 4 weeks.

Behavioral: Time-Restricted Feeding

Alternate Day Fasting

ACTIVE COMPARATOR

Participants in the alternate day fasting group are instructed to eat every second day ad libitum, but to abstain from calorie intake on fast days (100 % restriction) for 4 weeks.

Behavioral: Alternate Day Fasting

Control

NO INTERVENTION

Participants in the control group are instructed to maintain their habitual diet regimen.

Interventions

Time-Restricted Feeding BEHAVIORAL

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

Time-Restricted Feeding

Alternate Day Fasting BEHAVIORAL

Participants are instructed to fast every other day.

Alternate Day Fasting

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipp Gerber: lead

Study Sites (1)

Department of Endocrinology, Diabetology and Clinical Nutrition

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Derron N, Guntner AT, Weber IC, Braun J, Koska IO, Othman A, Monch L, von Eckardstein A, Puhan MA, Beuschlein F, Hochuli M, Zamboni N, Guggenberger R, Gerber PA. Alternate-day fasting elicits larger changes in fat mass than time-restricted eating in adults without obesity - A randomized clinical trial. Clin Nutr. 2025 Oct;53:212-221. doi: 10.1016/j.clnu.2025.08.033. Epub 2025 Sep 3.

  PMID: 40945487 DERIVED

MeSH Terms

Conditions

Intermittent Fasting; Overweight

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philipp Gerber, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc, Senior Physician / Group Leader

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 1, 2021
• Study Start: March 10, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)