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Clinical Trials/NCT04970589
NCT04970589CompletedPhase 1

Enhancing Efficacy of Mango Phytochemicals in Cognitive Function and Cardiometabolic Health in Lean and Obese

Texas A&M University2 sites in 1 country100 target enrollmentStarted: September 30, 2018Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Cognitive Function (the Wechsler Adult Scale-Revised Digit Span test)

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Males or females
  • BMI between 18-23 and 27-35

Exclusion Criteria

  • History of acute cardiac event, stroke, or cancer
  • Alcohol or substance abuse within the last 6 months
  • Pregnancy or lactation (or planned pregnancy)
  • No recurrent hospitalizations within the last 6 months
  • Allergy against any of the study treatments (mango or probiotics)
  • Liver or renal dysfunction
  • Hepatitis B or C, HIV
  • Currently smoking more than 1 pack/week
  • History of dizziness/fainting during/after blood draws

Outcomes

Primary Outcomes

Cognitive Function (the Wechsler Adult Scale-Revised Digit Span test)

Time Frame: At baseline and week 8

The Wechsler Adult Scale-Revised Digit Span test: On Days 1 and 54, Assessed the cognitive function of the subjects by giving them these tests. The Wechsler Adult Scale-Revised Digit Span is a measure of mental tracking, memory, and mental flexibility.

Cognitive Function (NeuroTracker)

Time Frame: From Week 6 to Week 8

NeuroTracker: Ten sessions should be completed between days 43 and 56. Fill out the NeuroTracker questionnaire to assess their emotional, mental, and physical state.

Cognitive Function (The Trail Making Test)

Time Frame: At baseline and week 8

The Trail Making Test (TMT A\&B) On Days 1 and 54, Assessed the cognitive function of the subjects by giving them these tests. The TMT A\&B Test assesses measure of attention, speed, mental flexibility, spatial organization, visual pursuits, recall, and recognition.

Secondary Outcomes

  • Change from baseline in the levels of metabolites of gallic acid in urine and plasma after mango intake.(At baseline and week 8)
  • Changes from baseline in the levels of Inflammatory biomarkers in plasma(At baseline and week 8)
  • Change from baseline in gut microbiota composition in stool samples(At baseline and week 8)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Susanne Talcott, PhD

Assoc. Professor

Texas A&M University

Study Sites (2)

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