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Does a 12-hour fast influence weight loss and cardiovascular risk in people with obesity?

Chronobiological influence of fasting time on weight loss and cardiovascular risk profile in an overweight or obese adult population: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN29704208
Enrollment
150
Registered
2020-12-15
Start date
2020-12-17
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Nutritional, Metabolic, Endocrine

Interventions

The intervention will consist of implementing, over six months, a 12-hour fasting period between the last evening-night food intake and the next intake during the morning of the following day.

Sponsors

University of Valencia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Volunteers recruited from the general population 2. Between 18 and 65 years old 3. BMI between 25 and 40 kg/m²

Exclusion criteria

Exclusion criteria: 1. Individuals who have previously undergone diets that include fasting for a period of greater than 12 hours over the last year or who have undertaken a restricted calorie intervention over the last six months, and those who have skipped normal meal times as a dietary practice. 2. Pregnant or breast-feeding women 3. Individuals with infectious diseases. 4. Liver cirrhosis or chronic renal failure 5. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression, etc 6. Cancer 7. Alcohol abuse or addition 8. Current treatment with systemic corticosteroids 9. Current use of weight loss medication 10. Any other condition that may interfere with the completion of the study protocol

Design outcomes

Primary

MeasureTime frame
Measured at baseline and during intervention (the first month, the third month and the sixth month): 1. Weight (kg) 2. Height (cm) 3. Waist circumference (cm) 4. Body composition measured by bioimpedance 5. Blood pressure and heart rate will be measured in triplicate using a validated semiautomatic oscillometer (Omron HEM-705CP, Netherlands) with 5 minutes of rest in-between measurements

Secondary

MeasureTime frame
At baseline and after the intervention: 1. Biochemistry (serum lipid concentrations, fasting glucose, glycated hemoglobin and uric acid) measured by blood and urine samples 2. Food intake and adherence to the Mediterranean diet will be measured using the 14-item Mediterranean diet adherence PREDIMED scale 3. The compliance with food and nutrient targets and dietary patterns will be evaluated using a validated 143-item food frequency questionnaire (FFQ) 4. Preference for different tastes will be measured using a Likert scale which has differents levels such as: 0-totally disagree to 3: totally agree 5. Physical activity will be measured using the short form of the Minnesota physical activity questionnaire 6. Sleep characteristics will be measured using the Pittsburgh Sleep Quality Index questionnaire 7. Chronotype will be measured using the Horne and Östberg questionnaire 8. Cognitive function will be measured using some tests (TMT-A, TMT-B, COWAT, Wechsler Adult Intelligence Scale-III)

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026