Preliminary Results for the NIH Protocol of the Mediterranean-like Unprocessed (CLEAN-MED) Diet Intervention Study of the Gut Microbiome of Healthy Adults

Authors

• E Abiona
• A Brichacek
• M Florkowski
• S Yang
• S Turner
• C Awuah
• S Burrison
• JJ Barb
• L Yang
• N Farmer
• G Wallen
• J Dekker
• K Frank

Abstract

The primary objective of this study is to measure changes within the gut microbiome in healthy adults transitioning from a Western diet to a Mediterranean-like unprocessed food (CLEAN-MED) diet. Additional objectives include identifying associations between the gut microbiome, biomarkers, and CLEAN-MED diet adherence. Sixty healthy adults will join a two-month randomized cross-over cohort consuming one month of an NIH-provided CLEAN-MED diet and one month of their habitual Western diet. A separate 12-month cohort of 50 volunteers will be educated to prepare their own CLEAN-MED foods. Volunteers must have a low baseline Mediterranean diet (MedDiet) score, and high ultra-processed food (UPF) consumption. Enrolled volunteers must submit food logs and photos at least three days per week. Nutritional analysis is conducted using Nutrition Data System for Research software. Fecal and fasting blood samples are collected weekly (short-term) or monthly (long-term). Preliminary results from September 2022 to present show the average baseline MedDiet score is 4 out of 17, with 54% calories from UPFs, while the provided CLEAN-MED diet has a MedDiet score of 15 and 0% calories from UPFs. The long-term cohort has an average baseline MedDiet score of 4 and 51% of calories from UPFs. By month 3, the average MedDiet score increased to 10, while UPF intake decreased to 14% of total calories. Changes in blood markers were observed in both cohorts, such as cholesterol. This study adds valuable data to the field as few studies examine the combination of MedDiet and UPFs, and fewer include detailed gut microbiome data.

Scientific Focus Area: Clinical Research

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