Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04100200 |
| Other study ID # |
IRB2018-121 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 7, 2019 |
| Est. completion date |
February 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Clinical Nutrition Research Center, Illinois Institute of Technology |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary objectives are to characterize changes in indices of systemic and gut
inflammation, assess host- and microbial-derived metabolite pools, and describe and link
functional metagenomics and metatranscriptomic alterations in the gut microbiome with
metabolite and inflammatory outcomes after acute (24hr) and chronic (4 week) intake of
anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet
(negative control), FOS (positive control, non-polyphenol, carbohydrate-based fermentable
fiber/pre-biotic), or combination diet (berry composite + FOS) in human participants with
low-grade inflammation.
Description:
The proposed study will be conducted in humans according to Good Clinical Practice (GCP)
guidelines. All subjects will review and sign an Informed Consent Form approved by the
Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
This is a single-center, randomized, single-blinded, 4-arm, placebo-controlled clinical
trial. It features an acute single exposure 24-h protocol and a chronic 4-week daily intake
protocol to evaluate the effects of anthocyanins and ellagitannins from strawberry and red
raspberry intake compared to a control diet, FOS, or FOS and berries combined on gut
inflammation, in adults with chronic low-grade inflammation.
A planned sample size of 88 will be enrolled in the study. This study will require one
initial screening visit, a pre-study visit, and 5 study visits. This study will take 5 weeks
per subject to complete.
The initial screening visit will provide subject with their site-specific, IRB-approved
informed consent document prior to the start of any study-related procedures. Subject
eligibility will be determined through a high sensitivity C-Reactive Protein (hs-CRP) marker
value, anthropometric measurements, vital signs, fasting blood glucose test (finger prick),
and completion of a survey related to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their
participation, although stricter guidelines will be imposed during the 3 days prior to a
study visit that involved blood/urine/fecal collection. Shopping lists and meal plans will be
provided to subjects, along with counseling by the investigator's study investigators, to
help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day
food diary to assess background (pre-study) dietary intake followed by counseling to follow a
diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the
duration of the experiment. After an initial 7-day wash-in period on the limited polyphenolic
diet, subjects will be randomized to 1 of 4 treatment sequences in the form of a drink: a
mixed berries diet (raspberries and strawberries), a FOS diet (non-polyphenol,
carbohydrate-based fermentable fiber/pre-biotic), a combination diet (mixed berries + FOS),
or a control diet (negative control). Subjects will receive the same treatment for the
duration of the study. Treatment codes will be maintained by the principal investigator.
Each visit will last ~2 hours and subjects will be required to remain at the Clinical
Nutrition Research Center for the duration of the visit. Fasting blood samples will be
collected at the 0 and 24h time points via a butterfly needle placed by a certified
phlebotomist.
