NCT03659240

Brief Summary

The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2019

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

September 3, 2018

Last Update Submit

February 28, 2023

Conditions

Dysbiosis

Outcome Measures

Primary Outcomes (1)

  • Fecal microbial community composition and structure

    We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage.

    Changes in the fecal microbiota will be measured after a 20-day intervention period

Study Arms (2)

Cranberry beverage

EXPERIMENTAL
Other: Cranberry beverage

Placebo beverage

PLACEBO COMPARATOR
Other: Placebo beverage

Interventions

Cranberry beverageOTHER

During the intervention period, research participants will consume a cranberry beverage daily.

Cranberry beverage
Placebo beverageOTHER

During the intervention period, research participants will consume a placebo beverage daily.

Placebo beverage

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 27-35 kg/m2
  • High waist circumference (men \>102 cm and women \>88 cm)

You may not qualify if:

  • Cigarette smoking
  • Regular intensive exercise
  • Pregnancy or lactation
  • Chronic diarrhea, constipation, or other gastrointestinal complaint
  • Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota
  • Use of medications that affect inflammation or the gut microbiota
  • Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota
  • Aversion to cranberries
  • Food allergies
  • Lactose intolerance
  • Vegetarianism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition and Wellness Research Center

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 6, 2018

Study Start

October 9, 2018

Primary Completion

February 24, 2019

Study Completion

February 24, 2019

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

US(1)