Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults

NCT06323889 | Recruiting

• 1 other identifier: LIMITFOOD2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Fasting; Obesity; Time Restricted Eating

Keywords

Overnutrition; Nutrition Disorders; Body Weight; Obesity; Longitudinal monitoring

Outcome Measures

Primary Outcomes (1)

• Fat Volume

  Change in body fat volume measured with MRI

  8 weeks

Secondary Outcomes (6)

• Distribution of fat volume

  8 weeks

• Concentration of Leptin

  8 weeks

• Changes in Insulin Sensitivity

  8 weeks

• Changes in Fasting Lipids

  8 weeks

• Changes in Inflammatory Markers

  8 weeks

Other Outcomes (5)

• Correlation of longitudinally measured parameters

  8 weeks

• Serum Metabolomics

  8 weeks

• Genetic Analysis

  8 weeks

Study Arms (3)

Modified Alternate Day Fasting (mADF)

ACTIVE COMPARATOR

Participants in the mADF group will be instructed to eat every second-day ad libitum ("feast days"), and to consume a very low carbohydrate snack, restricted to the evening, provided by the study team and to otherwise abstain from calorie intake on the rest of the fast day.

Behavioral: Modified Alternate Day Fasting

Time-Restricted Eating (TRE)

ACTIVE COMPARATOR

TRE participants are instructed to eat two main meals and limit snacking from 12:00 to 20:00 daily, and to fast from 20:00 until 12:00 daily

Behavioral: Time-Restricted Eating

Control group

OTHER

The control group will receive guidance on a quantitative reduction in total caloric intake by following a balanced diet, but no timing window for food intake will be prescribed to the participants in the control group.

Behavioral: Weight-loss counseling

Interventions

Modified Alternate Day Fasting BEHAVIORAL

Participants are instructed to fast every other day.

Modified Alternate Day Fasting (mADF)

Time-Restricted Eating BEHAVIORAL

Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day

Time-Restricted Eating (TRE)

Weight-loss counseling BEHAVIORAL

Participants will receive nutrition counseling to structure their main meals according to the plate model for weight-loss and to reduce number of consumed plates.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 the study
• HbA1c \< 6.5% without glucose lowering medication
• LDL-cholesterol \< 4.6mmol/l without lipid lowering medication

You may not qualify if:

• Participants 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 due to possible interference with metabolic parameters
• Food intolerances, allergies and sensitivities (severe 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 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 blood sugar, blood pressure or lipids
• Participants likely to fail to comply with the study protocol
• Participants who do not give informed consent

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Endocrinology, Diabetology and Clinical Nutrition

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Intermittent Fasting; Obesity; Overnutrition; Nutrition Disorders; Body Weight

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Overweight; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philipp Gerber, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonie Mönch, MSc

CONTACT

+41 44 255 31 64; leonie.moench@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 21, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)