Cranberry Juice for Cognitive Symptoms

Overseen By Liwei Gu

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Antibiotics

Disqualifiers: Heavy caffeine, Alcohol, Smoking, Diabetes, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cranberry juice can improve thinking skills and reduce stress for people who juggle multiple tasks daily. Participants will be randomly assigned to drink either cranberry juice or a placebo (a look-alike juice with no active ingredients) for 70 days to determine its effect on cognitive performance and stress-related issues like mood swings and fatigue. The trial seeks healthy individuals aged 30 to 55 who multitask regularly and meet specific lifestyle and health criteria, such as not having high blood pressure or using cannabis products.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance everyday cognitive function and stress management.

Do I have to stop taking my current medications to join the trial?

Yes, if you are taking medications like antibiotics that may influence the study outcomes, you will need to stop taking them to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cranberry juice is generally safe for most people. Studies have found that drinking cranberry juice regularly for several weeks can improve memory and brain function without major safety concerns. The European Food Safety Authority (EFSA) found no safety issues with cranberry extract, a concentrated form often used in research.

Cranberry is usually gentle on the stomach, but consuming large amounts might cause mild side effects like diarrhea or stomach discomfort. These effects are uncommon and usually minor. Overall, cranberry juice is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about cranberry juice as a treatment for cognitive symptoms because it offers a natural alternative to traditional medications. Unlike standard treatments that often rely on pharmaceuticals, cranberry juice is derived from a fruit known for its antioxidant properties. This could provide a gentler option with fewer side effects. Additionally, the unique compounds in cranberries might improve cognitive function by reducing oxidative stress and inflammation, pathways not typically addressed by conventional cognitive therapies.

What evidence suggests that cranberry juice might be an effective treatment for cognitive symptoms?

Research has shown that eating cranberries can improve memory and brain function. One study found that people who took cranberry supplements for 12 weeks experienced better memory and brain activity. Another study found that cranberries helped older adults enhance their visual memory. Berries related to cranberries are also known to boost brain function in healthy adults. This trial will test two versions of cranberry juice, Cranberry Juice A and Cranberry Juice B, to explore their potential effects on thinking skills and stress management. Although specific studies on cranberry juice and multitasking are lacking, these findings suggest that cranberry juice might help with cognitive symptoms. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 30-55 who multitask regularly. Participants must weigh at least 110 pounds, have a BMI of 18.9-29.9, and have completed high school education or higher.

Inclusion Criteria

BMI 18.9-29.9 kg/m^2

Education level high school and above

I weigh at least 110 pounds.

Exclusion Criteria

Have specific dietary restriction (prevent from consuming the standardized breakfast or dinner sandwiches)

Alcohol consumption (>3 alcohol/week)

Smoking (≥10 years)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Run-in

Participants start to follow the dietary restriction

3 weeks

No visits required

Treatment

Participants consume cranberry or placebo juice and complete various cognitive and physiological assessments

10 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cranberry Juice

Trial Overview The study tests if drinking cranberry juice with L-theanine for 70 days can improve thinking skills and reduce stress during multitasking compared to placebo juice or just cranberry juice in a randomized, double-blinded setup.

How Is the Trial Designed?

Group I: Cranberry juice B Experimental Treatment 1 Intervention

Cranberry juice B

Group II: Cranberry Juice A Experimental Treatment 1 Intervention

Cranberry juice A

Group III: Placebo juice Placebo Group 1 Intervention

Placebo juice that matches the appearance, taste, and calories of the treatment juices.

Cranberry Juice is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cranberry Juice for:

• Urinary Tract Infection (UTI) prophylaxis

Approved in European Union as Cranberry Juice for:

• Urinary Tract Infection (UTI) prophylaxis

Approved in Canada as Cranberry Juice for:

• Urinary Tract Infection (UTI) prophylaxis

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Cranberry extract (CBE) has been shown to effectively delay paralysis in a C. elegans model of Alzheimer's disease by reducing β-amyloid (Aβ) toxicity, indicating its potential as an anti-Alzheimer's agent.

The study found that CBE is more effective when used preventively rather than therapeutically, suggesting that early intervention may be key to maximizing its benefits against Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranberry extract supplementation exerts preventive effects through alleviating Aβ toxicity in Caenorhabditis elegans model of Alzheimer's disease. Guo, H., Dong, YQ., Ye, BP.[2017]

A modified method using 4-dimethylaminocinnamaldehyde was successfully validated to accurately quantify A-type proanthocyanidins (PACs) in cranberry products, which are believed to help prevent urinary tract infections.

The method demonstrated high reliability with calibration curves showing strong correlation (r2 > 0.99) and excellent recovery rates (97.1% and 99.1%) for PAC concentrations, indicating it can be a useful tool for the cranberry industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Laboratory Validation for Determination of Total Soluble Proanthocyanidins in Cranberry Using 4-Dimethylaminocinnamaldehyde. Sintara, M., Li, L., Cunningham, DG., et al.[2019]

A study involving 10 healthy adults aged 50 and older found that phenolic compounds from a low-calorie cranberry juice cocktail are bioavailable, peaking in plasma at 34.2μg/ml between 8 and 10 hours after consumption.

The research also revealed that cranberry juice consumption enhances total antioxidant capacity in the body, indicating potential health benefits related to antioxidant activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flavonoids and phenolic acids from cranberry juice are bioavailable and bioactive in healthy older adults. McKay, DL., Chen, CY., Zampariello, CA., et al.[2018]

Cranberry juice has been shown to effectively prevent urinary tract infections (UTIs) in women with recurrent cases, primarily due to its anti-adhesive properties that stop bacteria from attaching to tissues.

The active compounds responsible for this effect are proanthocyanidins, and cranberry products are considered safe while also offering additional health benefits like antioxidant and cholesterol-lowering effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranberry juice for prophylaxis of urinary tract infections--conclusions from clinical experience and research. Nowack, R., Schmitt, W.[2013]

The EFSA Panel concluded that cranberry extract powder, containing 55-60% proanthocyanidins (PACs), is safe for consumption as a novel food ingredient, based on its composition, production process, and human clinical studies.

The recommended intake of cranberry extract powder is 80 mg of PACs per serving, with average daily intakes estimated at 68 mg for women and 74 mg for men, which do not pose any nutritional disadvantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97. Turck, D., Bresson, JL., Burlingame, B., et al.[2023]

Cranberry ingredients are generally considered safe for human health when consumed in dietary supplements, leading to their acceptance for quality standard development by the U.S. Pharmacopeial Convention.

While cranberry may interact with warfarin and has been linked to kidney stone formation in some studies, significant risks are primarily associated with excessive intake, and moderate consumption does not pose serious health concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Cranberry: Evaluation of Evidence of Kidney Stone Formation and Botanical Drug-Interactions. Madden, E., McLachlan, C., Oketch-Rabah, H., et al.[2021]

A study involving healthy men and women showed that consuming three different cranberry extracts significantly enhanced the anti-adhesion activity of urine against harmful bacteria that cause urinary tract infections, specifically P-fimbriated Escherichia coli.

The cranberry extracts, each standardized to deliver 36 mg of proanthocyanidins (PACs), demonstrated this effect within 6 to 12 hours after intake, indicating a potential preventive measure for urinary tract health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Anti-Adhesion Activity of Three Different Cranberry Extracts on Uropathogenic P-fimbriated Escherichia coli: a Randomized, Double-blind, Placebo Controlled, Ex Vivo, Acute Study. Howell, A., Souza, D., Roller, M., et al.[2022]

Cranberry juice contains proanthocyanidins that prevent bacteria from sticking to tissues, which is an important mechanism for its effectiveness in treating and preventing infections.

Research supports the use of cranberry juice as a preventive measure against recurrent urinary infections in women, and its anti-adhesion properties may also be beneficial for other bacterial-related conditions like gastritis and dental diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cranberry juice-- a well-characterized folk-remedy against bacterial urinary tract infection. Nowack, R.[2022]

Cranberry (Vaccinium macrocarpon) has been shown to help prevent recurrent urinary tract infections (UTIs) in women by inhibiting the adhesion of E. coli bacteria to the bladder, thanks to specific compounds called proanthocyanidins (PAC).

Cranberry is a safe and well-tolerated supplement with no significant drug interactions, and while research is still in early stages, it may also offer additional health benefits such as anti-infective, anticancer, and antioxidant effects, as well as potential positive impacts on cardiovascular and metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccinium macrocarpon: an interesting option for women with recurrent urinary tract infections and other health benefits. Pérez-López, FR., Haya, J., Chedraui, P.[2009]

In a 6-week clinical trial involving 50 cognitively intact older adults, cranberry juice did not show significant improvements in neuropsychological functioning compared to a placebo, based on standardized tests.

However, there was a nonsignificant trend where more participants in the cranberry juice group reported improvements in their memory abilities, suggesting potential subjective benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blinded, placebo-controlled, randomized trial of the neuropsychologic efficacy of cranberry juice in a sample of cognitively intact older adults: pilot study findings. Crews, WD., Harrison, DW., Griffin, ML., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160193/

Chronic Consumption of Cranberries (Vaccinium ... Daily cranberry supplementation (equivalent to 1 small cup of cranberries) over a 12-week period improves episodic memory performance and neural functioning.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05008549

A Study to Assess the Synergistic Effects of a Cranberry ... 1.1 Background information Berries from the Vaccinium genus have been reported to improve some measures of cognitive function in healthy adults. There is ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35662954/

Chronic Consumption of Cranberries (Vaccinium ... Results: Cranberry supplementation for 12 weeks was associated with improvements in visual episodic memory in aged participants when compared to placebo.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06066619/can-cranberry-juice-enhance-the-cognition-accuracy-and-alleviate-negative-mental-consequences-during-multitasking

Can Cranberry Juice Enhance the Cognition Accuracy and ... This clinical trial aims to investigate the effects of a 70-day consumption of cranberry juice on cognitive and motor accuracy, mental and physiological stress ...

5. withpower.com withpower.com/trial/phase-neurobehavioral-manifestations-2024-05fee

Cranberry Juice for Cognitive Symptoms · Info for Participants This clinical trial aims to investigate the effects of a 70-day consumption of cranberry juice on cognitive and motor accuracy, mental and physiological ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-958/cranberry

Cranberry - Uses, Side Effects, and More There isn't enough reliable information to know if cranberry is safe to use as medicine or what the side effects might be. Aspirinallergy: Cranberries contain ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK588846/

Cranberry - LiverTox - NCBI Bookshelf - NIH Cranberry is generally well tolerated without adverse events. With high doses, minor side effects may include diarrhea, abdominal discomfort and ...

8. sciencedirect.com sciencedirect.com/topics/nursing-and-health-professions/cranberry-extract

Cranberry Extract - an overview Drink 8 oz of unsweetened cranberry juice daily, or take a standardized solid cranberry extract, one capsule three times daily for prevention.