Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04551937
Other study ID # 16840
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2018
Est. completion date September 18, 2018

Study information

Verified date September 2020
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.


Description:

Evidence-based dietary strategies provide behavioral means benefiting physical and cognitive function. Pertinent to the proposed work, dietary intake has been recently shown to have the potential to directly influence the gut microbiota composition as well as brain function. Specifically, the consumption of prebiotics or fibers metabolized by gut bacteria may also play a role. These foods are readily available in the marketplace, however, their implications for physical and cognitive function are not clear. Accordingly, the proposed study aims to investigate effects of prebiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 18, 2018
Est. primary completion date September 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria:

- Males and females

- Between the ages of 25-45 years at the time of consent

- BMI =18.5 kg/m2

- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task.

- Ability to drop-off fecal sample within 15 minutes of defecation

Exclusion Criteria:

- Current pregnancy or lactation

- Tobacco use

- Dairy allergy or intolerance

- Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)

- Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease

- Use of any anti-psychotic, anti-depressant, antianxiety, or ADD/ADHD medications

- Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antispasmodics, diuretics, anticonvulsants).

- Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)

Study Design


Intervention

Other:
Lactose Free 1% Milk
8 oz of study beverage daily
Lactose Free 1% Milk + 10 g prebiotic
8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide

Locations

Country Name City State
United States University of Illinois Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biological markers of stress Changes in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP). 4-5 weeks
Primary Behavioral markers of stress Change in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire. 4-5 weeks
Secondary Gastrointestinal Microbiota composition Impact on bacterial genera abundances. 4-5 weeks
Secondary Gastrointestinal microbiota beta-diversity Impact on beta-diversity measures 4-5 weeks
Secondary Gastrointestinal Microbiota alpha-diversity Impact on alpha-diversity measures 4-5 weeks
Secondary Cognitive function Computer tasks will be used to assess working memory, interference control, cognitive flexibility, and hippocampal function/relational memory 4-5 weeks
Secondary Sleep The Pittsburg Sleep Quality Index (PSQI) will also be used to assess sleep, as will actigraphy. 4-5 weeks
See also
  Status Clinical Trial Phase
Completed NCT05712005 - Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study
Completed NCT05343208 - Effectiveness of Online Therapy to Prevent Burnout N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03987477 - Online Intervention to Modify Interpretation Biases in Depression N/A
Completed NCT03695003 - Cognitive Effects of Sage in Healthy Humans N/A
Completed NCT05075850 - Multicenter Sub-study for LAANTERN Registry NCT02392078 That Will Include Comprehensive Neuropsychological Assessment Data Collection
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Completed NCT03674281 - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System N/A
Completed NCT03689348 - Acute and Chronic Effects of Avena Sativa on Cognition and Stress N/A
Active, not recruiting NCT05229705 - Exercise in Older Adults at Risk for Type 2 Diabetes N/A
Suspended NCT05001789 - Cognitive Functioning in Opioid Use Disorder N/A
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Completed NCT03657537 - Effects of Ketone Bodies on Cognition in Type 2 Diabetes Phase 1
Completed NCT05543811 - The Influence of Food for Special Dietary Use - Spread Enriched With 5-hydroxytryptophan, Theanine and Gamma-aminobutyric Acid on Psychophysiological Functions of Subjects Without Meaningful Organic and Cognitive Pathology N/A
Recruiting NCT05699226 - Amplitude Titration to Improve ECT Clinical Outcomes N/A
Recruiting NCT05026541 - Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators N/A
Active, not recruiting NCT03255499 - Efficacy of the MovinCog Intervention in Children N/A
Not yet recruiting NCT06252376 - Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD N/A