Overweight Clinical Trial
— LIMITFOODOfficial title:
Longitudinal Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults - A Randomized Clinical Trial
NCT number | NCT04732130 |
Other study ID # | LIMITFOOD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 10, 2021 |
Est. completion date | July 1, 2023 |
Verified date | October 2023 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Endocrinology, Diabetology and Clinical Nutrition | Zürich |
Lead Sponsor | Collaborator |
---|---|
Philipp Gerber |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fat mass | Change in whole body fat mass | 4 weeks | |
Secondary | Continuous glucose monitoring (CGM) | During the study period the CGM system will measure the continuous glucose concentration of the participants and thereby any changes will be measured. | 4 weeks | |
Secondary | Physical activity energy expenditure | Change in mean physical activity energy expenditure will be recorded using an Actiheart monitor during the intervention. | 4 weeks | |
Secondary | Resting metabolic rate (measured by indirect calorimetry) | Change in resting metabolic rate | 4 weeks |
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