mini-Med for Eating Habits

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Colorado School of Medicine, Aurora, COEating HabitsSemi-controlled dietary intervention - MiniMed - Other
Eligibility
30 - 69
All Sexes
What conditions do you have?
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Study Summary

This trial compares the health benefits of a Mediterranean-style diet of whole grains, fruits and veggies to a typical Western-style diet. Results could inform dietary recommendations to reduce chronic diseases.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Med-Jet
1
Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED
1
Dietary Intervention

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Baseline to endline changes over each 4-week dietary intervention period

Baseline to endline changes in food-specific compounds over each 4-week dietary intervention period
Foodomics
Baseline to endline changes over each 4-week dietary intervention period
Cardiometabolic Health - Adipokines
Cardiometabolic Health - Blood Pressure
Cardiometabolic Health - C-reactive protein
Cardiometabolic Health - Glucose
Cardiometabolic Health - HDL Cholesterol
Cardiometabolic Health - IL-6
Cardiometabolic Health - Insulin
Cardiometabolic Health - LDL Cholesterol
Cardiometabolic Health - TNF-alpha
Cardiometabolic Health - Total Cholesterol
Cardiometabolic Health - Triglycerides
Cardiometabolic Health - alpha-1-acid glycoprotein
Gut Microbiota

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Med-Jet
1
Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MED
1
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Trial Design

2 Treatment Groups

Western
1 of 2
mini-Med
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: mini-Med · No Placebo Group · N/A

mini-MedExperimental Group · 2 Interventions: Semi-controlled dietary intervention - MiniMed, Semi-controlled dietary intervention · Intervention Types: Other, Other
WesternActiveComparator Group · 2 Interventions: Semi-controlled dietary intervention - Western, Semi-controlled dietary intervention · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to endline changes over each 4-week dietary intervention period

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,185 Previous Clinical Trials
4,089,789 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,607 Previous Clinical Trials
1,932,303 Total Patients Enrolled
Purdue UniversityOTHER
212 Previous Clinical Trials
63,771 Total Patients Enrolled
National Cattlemen's Beef AssociationOTHER
22 Previous Clinical Trials
1,036 Total Patients Enrolled
Nancy F Krebs, MDPrincipal InvestigatorUniversity of Colorado School of Medicine
2 Previous Clinical Trials
107 Total Patients Enrolled
Nichole Reisdorph, PhDPrincipal InvestigatorUniversity of Colorado School of Pharmacy
Wayne Campbell, PhDPrincipal InvestigatorPurdue University
4 Previous Clinical Trials
140 Total Patients Enrolled

Eligibility Criteria

Age 30 - 69 · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are overweight or obese with a body mass index (BMI) between 25 and 37 kg/m2 and have not gained or lost a significant amount of weight recently.
You do not smoke cigarettes, marijuana or any other substances that are inhaled.
You have been consistently active for at least 3 months before and during the study.
Your regular diet does not follow the Mediterranean diet pattern, which is evaluated using a tool called the Mediterranean Diet Assessment Tool.
You eat a varied diet and are willing to eat all the foods provided for the study (such as fish, fruits, vegetables, and beef).
You must not take any supplements or vitamins except for the ones prescribed by your doctor during the study.
References

Frequently Asked Questions

Is the participant eligibility for this research limited to individuals over twenty years old?

"The requirements to be admitted into this medical trial specify that the participant must range in age from 30-69 years old. For those younger than 18 and older than 65, there are 6 studies and 11 studies respectively available for them." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor presently seeking participants?

"Affirmative. The clinical trial details found on the official website suggest that it is seeking participants at this time; first posted in November 2021 and last updated December 15th 2022." - Anonymous Online Contributor

Unverified Answer

Is it feasible to join this research endeavor?

"This research project is looking for 40 individuals aged between 30 and 69 with dietary customs to participate. Patients must meet the following prerequisites: Age bracket of 30-69, abstain from smoking (including marijuana), have at least three components of Metabolic Syndrome or be on medicines for hyperglycemia, hypertension etc., being overweight/obese (BMI 25-37 kg/m2) while remaining weight stable; no changes in medications within 6 months prior to study period; adhere to a diet not meeting Mediterranean style criteria as per MDAT score (<5); consume omnivorous foods including salmon, fruits/vegetables and" - Anonymous Online Contributor

Unverified Answer

What is the total participant count of this investigation?

"Affirmative. Clinicaltrials.gov's database reveals that this clinical trial, which was initially posted on November 21st 2022, is actively recruiting volunteers. 40 individuals need to be enrolled from a single facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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