Clinical trial NCT02148458: Short Term Intermittent Fasting and Mediterranean Diet
Official title: Metabolic and Molecular Effects of a Mediterranean Diet and Intermittent Fasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Pre-hypertension
Hypertension
Hypercholesterolemia
Glucose Intolerance
Keywords: Intermittent fasting
Mediterranean diet
overweight
Calorie restriction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate the effects of intermittent fasting in subjects that are eating a Mediterranean diet or a Western diet. This study is part of ongoing research in the prevention and treatment of age-related diseases at Washington University School of Medicine.

Detailed description: The primary objective of this study is to determine whether or not IF, independently of changes in quality of diet, reduces the level of chronic inflammation as evidenced by a decrease in high sensitivity C-reactive protein (hsCRP), as the main outcome measure.

Eligibility criteria: Inclusion Criteria:

1. - The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high-normal to moderately overweight range (i.e. 22 to 28 kg/m2),
2. - Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).
3. - Participants have at least one of these metabolic abnormalities: pre-hypertension or hypertension (i.e. systolic blood pressure \> 120 mmHg or diastolic blood pressure \> 80 mmHg or specific treatment of previously diagnosed hypertension)10, sub-optimal lipid levels (i.e. LDL-cholesterol \> 100 mg/dl or HDL-cholesterol \< 59 mg/dl or specific treatment for this lipid abnormality)11, impaired fasting glucose or glucose intolerance (i.e. fasting glucose \> 100 mg/dl or 2 hr-glucose during OGTT with a glucose load of 75 g \> 140 mg/dl or specific treatment for previously diagnosed type 2 diabetes)12, or high-risk waist circumference (≥ 94 cm in men and ≥ 80 cm in women)13.

Exclusion Criteria:

- 1 - History of any chronic disease process that could interfere with interpretation of results 2 - Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.

3 - Currently eating diet similar to Mediterranean diet based on dietary and food frequency questionnaires and 4-day food diary.

Primary outcomes:
measure: Decrease in high sensitivity C-reactive protein (hsCRP)
timeFrame: 16 weeks-- Baseline, 8 weeks, 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University school of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Valeria Tosti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Luigi Fontana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.