Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06323889

Longitudinal Monitoring of Two Intermittent Fasting Methods Compared to Weight-Loss Counseling in Obese Adults A Randomized Clinical Trial

Led by University of Zurich · Updated on 2024-12-20

90

Participants Needed

1

Research Sites

118 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates the effects of two different intermittent fasting methods compared to a control group on the health of obese adults aged 18 to 50 years. Researchers aim to compare modified alternate day fasting and time-restricted eating with general weight-loss counseling in obese individuals with a body mass index between 30 and 40. The study addresses the growing problem of obesity and related health risks, exploring how intermittent fasting may help with weight control and metabolic health. Participants are divided into three groups: one follows a modified alternate day fasting schedule where they fast every other day, the second group practices time-restricted eating by limiting food intake to two main meals within an 8-hour window daily, and the third receives nutrition counseling based on the plate model to reduce meal portions. These behavioral interventions are monitored over the study period to compare their effects on fat volume and other health markers. Throughout the study, participants undergo regular assessments including monitoring of body fat volume at 8 weeks. Researchers will track individual progress using established and new tools to evaluate changes in weight and metabolic health. The study also involves careful screening to ensure participants meet health and lifestyle criteria, with follow-up evaluations to measure outcomes and safety during the trial.

CONDITIONS

Official Title

Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 50 years, inclusive
  • Obese with BMI between 30 and 40 kg/m2 (obesity grade I or II)
  • Non-smoker
  • Good knowledge of German or English
  • Stable weight change (less than +/- 3% bodyweight) for 3 months before the study
  • HbA1c less than 6.5% without glucose-lowering medication
  • LDL cholesterol less than 4.6 mmol/l without lipid-lowering medication
Not Eligible

You will not qualify if you...

  • Regular fasting periods longer than 12 hours per day or eating fewer than three main meals daily
  • Current use of dietary supplements or unwillingness to stop them
  • Antibiotic use in the 3 months before the study
  • Food intolerances, severe allergies, or dietary restrictions such as veganism
  • Acute or chronic infections, cancer, kidney or liver disease (more than two-fold increased transaminases), lung, neurological, psychiatric diseases, or severe atherosclerosis
  • Diabetes
  • Known alcohol, substance, or drug abuse
  • Use of certain medications including hormonal supplements, antidepressants within 6 months, acetylsalicylic acid, or drugs regulating blood sugar, blood pressure, or lipids
  • More than four hours of exercise per week
  • Pregnancy, breastfeeding, or planning pregnancy during the trial
  • Irregular menstrual cycle according to FIGO criteria
  • Likely inability to comply with study protocol
  • Not providing informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Department of Endocrinology, Diabetology and Clinical Nutrition

Zurich, Canton of Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

L

Leonie Mönch, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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