Cherries Role in Gut Microbiota-liver-brain Function

NCT05586386 | Completed Phase 1 DMC

• 1 other identifier: IRB2019-0597F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sweet cherries (Prunus avium) are a good source of bioactive compounds including dietary fiber and phytochemicals which have been credited with multiple health benefits, including anti-inflammatory and antioxidant properties as well as preventing obesity-related metabolic disorders. However, most studies have shown such benefits using in vitro or animal models. The aim of this study was to examine the influence of DSC consumption on obesity-associated inflammation, metabolic disorders, cognitive impairment, and gut dysbiosis in obese individuals.

Conditions

Obesity

Keywords

dark sweet cherry; anthocyanins; obesity

Outcome Measures

Primary Outcomes (5)

• Change from baseline intestinal microbiota composition at 30 days

  16S rRNA sequencing was used to evaluate the intestinal microbiota composition in stool samples collected on day 1 (baseline) and 30.

  At day 1 (baseline) and day 30

• Change from baseline liver health biomarkers at 30 days

  Liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase) levels were measured on fasting blood samples collected on day 1 and 30.

  At day 1 (baseline) and day 30

• Change from cognitive function at 30 days

  The trail making tests (A and B) were administered on day 1 and 30 to evaluate executive attention, and visual-spatial functions (visual search and scanning, sequencing).

  At day 1 (baseline) and day 30

• Change from cognitive function at 30 days

  The Digit Span tests (Forward and Backward) were administered on day 1 and 30 to evaluate working memory and concentration skills.

  At day 1 (baseline) and day 30

• Change from cognitive function at 30 days

  The Digit Span Substitution test was administered on days 1 and 30 to evaluate processing speed, sustained attention, and visual perception.

  At day 1 (baseline) and day 30

Secondary Outcomes (3)

• Change from baseline inflammatory biomarkers at 30 days

  At day 1 (baseline) and day 30.

• Visual cognitive performance

  From day 15 to day 30.

• Change from baseline lipid profile biomarkers at 30 days

  At day 1 (baseline) and day 30

Study Arms (2)

Cherry group

EXPERIMENTAL

Obese adults were asked to consume 200 mL of DSC juice supplemented with 3g of DSC powder twice / day for 30 days.

Other: Cherry group

Placebo group

EXPERIMENTAL

Obese adults were asked to consume 200 mL of placebo juice supplemented twice / day for 30 days.

Other: Placebo group

Interventions

Cherry group OTHER

200 mL of DSC juice twice/day supplemented with 3g of DSC powder twice/day for 30 days

Cherry group

Placebo group OTHER

200 mL of placebo juice twice/day

Placebo group

Eligibility Criteria

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

You may qualify if:

• Male or female at least 18 years old;
• No history of chronic diseases or intestinal disorders.
• BMI: ≥ 30 and ≤ 40.

You may not qualify if:

• History of acute cardiac event, stroke, or cancer
• Alcohol or substance abuse within the last 6 months
• Recurrent admittance to the hospital (twice or more)
• Allergy, intolerance, or sensitivity to berries
• Hepatitis (B or C) or HIV
• Smoking more than 1 pack/week
• Liver or renal dysfunction
• Diabetic retinopathy
• History of glaucoma, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, macular degeneration or autoimmune disorders related to visual health
• History of dizziness/fainting during and after blood draws
• Known lactose intolerance, gluten sensitivity, or celiac disease
• Currently on medications/antibiotics
• Pregnancy or lactation (or planned pregnancy)

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

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Scientist

Model Details: Group 1: Obese adults (BMI: 30-40): 200 mL (\~6.7 oz.) of dark sweet cherry (DSC) juice supplemented with 3g of DSC powder twice per day for 30 days. Group 2: Obese adults (BMI: 30-40): 200 mL (\~6.7 oz.) of placebo juice twice per day for 30 days.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 19, 2022
• Study Start: February 6, 2020
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

US (1)