Short Term Intermittent Fasting and Mediterranean Diet

Hypertension Clinical Trial

Official title:

Metabolic and Molecular Effects of a Mediterranean Diet and Intermittent Fasting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148458
• Other study ID #: 201404045
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: May 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Hypercholesterolemia
• Hypertension
• Overweight
• Pre-hypertension
• Prehypertension

Intervention

Other:
• Mediterranean diet
Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week)
• Control group
control group eating their usual Western diet for 8 weeks, followed by 8 weeks of usual diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week).

Locations

Country	Name	City	State
United States	Washington University school of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in high sensitivity C-reactive protein (hsCRP)	hsCRP is in mg/L	16 weeks-- Baseline, 8 weeks, 16 weeks