Enhancing Efficacy of Mango Polyphenols in Lean and Obese

NCT04970589 | Completed Phase 1 DMC

• 1 other identifier: TexasAMU-IRB2018-0405F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Cognitive Function (NeuroTracker)

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

  From Week 6 to Week 8

• Cognitive Function (The Trail Making Test)

  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.

  At baseline and week 8

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

  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.

  At baseline and week 8

Secondary Outcomes (3)

• Changes from baseline in the levels of Inflammatory biomarkers in plasma

  At baseline and week 8

• Change from baseline in the levels of metabolites of gallic acid in urine and plasma after mango intake.

  At baseline and week 8

• Change from baseline in gut microbiota composition in stool samples

  At baseline and week 8

Study Arms (4)

Lean/Placebo Capsule

PLACEBO COMPARATOR

Participants (Lean:BMI 18-23) will be asked to take 400g of mango and a placebo capsule every day for 8 weeks

Other: Mango; Other: Placebo

Lean/Probiotics

EXPERIMENTAL

Participants (Lean:BMI 18-23) will be asked to take 400g of mango and a probiotic capsule every day for 8 weeks

Other: Mango; Dietary Supplement: Probiotics

Obese/Placebo Capsule

EXPERIMENTAL

Participants (Obese:BMI 27-35) will be asked to take 400g of mango and a placebo capsule every day for 8 weeks

Other: Mango; Other: Placebo

Obese/Probiotics

EXPERIMENTAL

Participants (Obese:BMI 27-35) will be asked to take 400g of mango and a probiotic capsule every day for 8 weeks

Other: Mango; Dietary Supplement: Probiotics

Interventions

Mango OTHER

400g of mango/day

Lean/Placebo Capsule; Lean/Probiotics; Obese/Placebo Capsule; Obese/Probiotics

Probiotics DIETARY_SUPPLEMENT

1 probiotics capsule/day

Lean/Probiotics; Obese/Probiotics

Placebo OTHER

1 Placebo capsule/day

Lean/Placebo Capsule; Obese/Placebo Capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Mangifera indica extract; Probiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Susanne Talcott, Ph.D

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor

Model Details: Group 1: BMI 18-23: 400g of mango and a placebo capsule every day for 8 weeks Group 2: BMI 18-23: 400g of mango and a probiotic capsule every day for 8 weeks Group 3: BMI 27-35: 400g of mango and a placebo capsule every day for 8 weeks Group 4: BMI 27-35: 400g of mango and a probiotic capsule every day for 8 weeks

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 21, 2021
• Study Start: September 30, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 28, 2019
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

US (1)