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

126 Participants Needed

Trial Summary

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.

What data supports the idea that Cranberry Juice for Cognitive Symptoms is an effective treatment?

The available research shows limited direct evidence supporting cranberry juice as an effective treatment for cognitive symptoms. One study aimed to test its effects on older adults' brain function, but it was only a short-term pilot study. However, cranberry extract has shown potential in a model of Alzheimer's disease by reducing harmful effects related to memory loss, suggesting it might help prevent memory issues. Most research focuses on cranberry's benefits for urinary tract health, not cognitive symptoms. ^{1 2 3 4 5}

What safety data exists for cranberry juice or extract?

Cranberry juice and extract are generally considered safe for consumption. The EFSA Panel found no safety concerns with cranberry extract powder as a novel food ingredient. The U.S. Pharmacopeial Convention concluded that cranberry ingredients are not associated with serious health risks when consumed properly, though potential interactions with warfarin and kidney stone formation were noted. However, these risks are associated with excessive intake or specific health conditions. Overall, cranberry products are safe at recommended levels. ^{1 3 4 6 7}

Is cranberry juice a promising treatment for cognitive symptoms?

Yes, cranberry juice is a promising treatment for cognitive symptoms. Studies show that it contains compounds like flavonoids and phenolic acids, which are bioavailable and have antioxidant effects. These compounds may help improve brain function in older adults. Additionally, cranberry extract has shown potential in preventing Alzheimer's disease symptoms in experimental models. ^{1 5 8 9 10}

What is the purpose of this trial?

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, and stress response in healthy men and women between the ages of 30 and 55 who engage in multitasking. The trial will utilize a randomized, double-blinded, placebo-controlled design. It is worth noting that studies have shown that over half of middle-aged Americans experience stress, which can lead to cognitive decline and depression. Previous clinical trials have indicated that consuming polyphenol-rich foods can have positive effects on cognitive function in humans. However, no study to date has examined the long-term effects of cranberry juice consumption on cognitive performance, mental stress, and stress response specifically in individuals engaged in multitasking. Based on this gap in knowledge, the investigators hypothesize the following: (1) chronic consumption of cranberry juice will improve cognitive and motor accuracy, as well as mental and psychological stress responses in young adults subjected to intense multitasking. (2) cranberry juice consumption will alleviate the negative consequences of frequent intense multitasking, such as fatigue, mood fluctuations, cognitive impairment, and memory issues. Additionally, it is expected to have a positive impact on stress biomarkers and neurotransmitter levels. By conducting this clinical trial, the investigators aim to shed light on the potential benefits of cranberry juice consumption in improving cognitive performance, mitigating mental stress, and positively influencing stress responses in individuals who engage in intense multitasking.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

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]

References

1. United States 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. [2015]

2. Australia pubmed.ncbi.nlm.nih.gov

Vaccinium macrocarpon: an interesting option for women with recurrent urinary tract infections and other health benefits. [2009]

3. Austria pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Cranberry extract supplementation exerts preventive effects through alleviating Aβ toxicity in Caenorhabditis elegans model of Alzheimer's disease. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety of Cranberry: Evaluation of Evidence of Kidney Stone Formation and Botanical Drug-Interactions. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Flavonoids and phenolic acids from cranberry juice are bioavailable and bioactive in healthy older adults. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Single-Laboratory Validation for Determination of Total Soluble Proanthocyanidins in Cranberry Using 4-Dimethylaminocinnamaldehyde. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Cranberry juice for prophylaxis of urinary tract infections--conclusions from clinical experience and research. [2013]