Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04970589 |
| Other study ID # |
TexasAMU-IRB2018-0405F |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2018 |
| Est. completion date |
December 28, 2019 |
Study information
| Verified date |
July 2021 |
| Source |
Texas A&M University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this research is to determine beneficial impact of mango phytochemicals in
lean and obese individuals for cognitive function and gut health. Investigate how obesity
impacts the efficacy of mango polyphenols on cognitive function and health. Investigate the
ability of probiotic bacteria to optimize the absorption and efficacy of mango phytochemicals
in lean and obese individuals.
Description:
Rationale: In obesity, interactions between adipocytes and macrophages are of increasing
importance to understanding obesity and chronic diseases. Dietary compounds, such as
polyphenols, are expected to cause significant changes in inflammatory biomarkers in lipid
tissue that are different from those in blood. To capture any changes of macrophages
interacting with lipid tissue and associated biomarkers, lipid biopsies were collected in
this study.
Before the study day: Participants were advised to not eat anything after dinner at 7-8pm the
night (A 12-hour fast). Drink plenty of water, at least 8 fl oz in the evening and 8 fl oz in
the morning. Participants were advised to eat a well-balanced meal consisting of 25%
protein-rich food, 25% whole grain high-fiber carbohydrate, and 50% fruits and vegetables
prior to beginning of fast. Prior to the first study session, participants were asked to fill
out a 72-h nutritional report with all food and drinks consumed using a website
(www.mynetdiary.com)
Study day: Participants were asked to consume 400 g of cubed, fresh mango during the early
morning hours of the study day starting right after the baseline blood draw. If they were in
the placebo group, they were asked to take one placebo capsule daily. The placebo used in
this study consisted of vegetable cellulose (HPMC USP) filled with 100% microcrystalline
cellulose USP. If they were in the probiotic group, they were asked to take one capsule of
the Renew Life Ultimate Flora "Extra Care" probiotic daily.
Study Treatment: In this study participants were placed into one of four different groups
depending on their BMI. The study treatment depended on which study group they were in:
BMI 18-23, Group 1: They were asked to consume a single portion of 400g of mango and take one
placebo capsule every day for the duration of the 8-week study.
BMI 18-23, Group 2: They were asked to consume a single portion of 400g of mango and take one
probiotic capsule every day for the duration of the 8-week study.
BMI 27-35, Group 1: They were asked to consume a single portion of 400g of mango and take one
placebo capsule every day for the duration of the 8-week study.
BMI 27-35, Group 2: They were asked to consume a single portion of 400g of mango and take one
probiotic capsule every day for the duration of the 8-week study.
Subjects did not know if they received probiotic or placebo capsules as part of their study
treatment. During all sessions, subjects were asked questions about their general health.
Study Session 1 (Days 1-3): Blood samples (30 mL or 6 teaspoons each) were taken before and 2
hours after mango consumption (Days 1, 2, and 3) by the study phlebotomist. Subjects were
asked to collect approximately 3 fl. oz (half a cup) of urine in the morning of Days 1, 2,
and 3, and 3 fl. ox (half a cup) in the evening of Days 1 and 2. They were also asked to
collect a stool sample to bring on Day 1. The researchers gave the subjects containers for
the urine and a kit for stool collection, as well as instructions on how to collect each of
those samples. Instructions on how to transport those samples were also given to them. During
Study Session 1 (Day 1), subjects took two cognitive function tests (Trail Making and Digit
Span).
Study Session 2 (Day 29): The study phlebotomist collected a single blood sample (30 mL or 6
teaspoons) from the subject's arm. Participants were also asked to collect a stool sample
using a collection kit we will provide.
NeuroTracker Sessions: During the last two weeks of the study (between days 43 and 56),
subjects were asked to come to our facility to perform a total of ten sessions using the
NeuroTracker, a cognitive function test. They could perform up to one session per day, and
all ten sessions were completed between days 43 and 56. Before each session, subjects were
asked to fill out the NeuroTracker questionnaire (to assess their emotional, mental, and
physical state) and a food log.
Study Session 3 (Days 54-56): Blood samples (30 mL or 6 teaspoons each) were taken right
before and 2 hours after mango consumption (Days 54, 55, and 56) by the study phlebotomist.
Subjects were asked to collect approximately 3 fl. oz (half a cup) of urine in the morning of
Days 54, 55, and 56, and 3 fl. ox (half a cup) in the evening of Days 54 and 55. They were
also asked to collect a stool sample to bring on Day 54. The researchers gave the subjects
containers for the urine and a kit for stool collection, as well as instructions on how to
collect each of those samples. Instructions on how to transport those samples were also given
to them. During this session (Day 54), subjects took two cognitive function tests (Trail
Making and Digit Span). On Day 56, we measured the participant's body fat using an Omron
Handheld Body Fat Monitor.
Cognitive Function Testing: On Days 1 and 54, we assessed the cognitive function of the
subjects by giving them the following tests: The Trail Making Test (TMT A&B) and the Wechsler
Adult Scale-Revised Digit Span test.
During the last two weeks of the study (between days 43 and 56), subjects were also run
through our NeuroTracker program. This was to test their spatial awareness. The TMT A&B Test
assesses measure of attention, speed, mental flexibility, spatial organization, visual
pursuits, recall, and recognition. The Wechsler Adult Scale-Revised Digit Span is a measure
of mental tracking, memory, and mental flexibility.
Lipid biopsy - Optional: This study included an optional lipid biopsy component and
participants were free to agree to participate in this procedure at the beginning and end of
this study.
This procedure was performed under supervision of the study physician Dr. Bramhal and
performed by Dr. Jim Fluckey and Dr. Steven Riechman.
