Goode Health Beverage for Overall Health

Recruiting at 1 trial location

Overseen By Alison Mancera, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Disqualifiers: Food allergy, Pregnant, Breastfeeding, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Goode Health Beverage for overall health?

Research on oral nutritional supplements (ONS), which are similar to Goode Health Beverage, shows they can improve energy and protein intake in people with poor nutrition, like aged care residents. This suggests that Goode Health Beverage might help improve nutritional intake and overall health. ^{1 2 3 4 5}

Is Goode Health Beverage safe for human consumption?

The safety of health foods, including products like Goode Health Beverage, is a concern due to reports of serious adverse events such as liver and kidney failure, and even death, associated with some health products. These issues often arise from undeclared ingredients or contaminants, and the lack of post-marketing surveillance makes it difficult to ensure safety. ^{6 7 8 9 10}

How is Goode Health Beverage different from other treatments for overall health?

Goode Health Beverage is unique because it combines natural nutrients from whole fruits and vegetables, similar to GrandFusion®, with bioactive compounds from Matcha green tea, offering antioxidant and anti-inflammatory benefits in a convenient drink form. ^{11 12 13 14 15}

What is the purpose of this trial?

The overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Good Health beverage on indices of physiological and neurocognitive health.

Research Team

Robert M Brothers, PhD

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

This trial is for individuals who want to improve their heart health and brain function. It's not clear what specific conditions or characteristics participants need to have, or what would disqualify someone from participating.

Inclusion Criteria

I am between 18 and 55 years old.

Exclusion Criteria

History of any food allergy

Pregnant women

Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then we may still opt to proceed with data collection

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume the Goode Health Beverage daily to assess its impact on physiological and neurocognitive health

2 weeks

Baseline and post-treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Goode Health Beverage

Trial Overview The study is testing the effects of a daily Goode Health Beverage on physical health markers like blood pressure and heart disease risk, as well as mental sharpness and cognitive abilities.

Participant Groups

Group I: Goode Health Beverage Experimental Treatment 1 Intervention

Goode Health Beverage that is high in natural ingredients that are high in Polyphenol 3 content and also have anti-inflammatory and antioxidant properties

Group II: Vanilla Base Blend Beverage Placebo Group 2 Interventions

The control beverage is similar but it does not contain the same amount of fiber, anti-inflammatory, and/or antioxidant properties (i.e. mainly smaller or no amounts of flax, ginger, cinnamon, turmeric, berberine bergamot, bilberry, black garlic, and green tea).

Goode Health Beverage is already approved in United States for the following indications:

Approved in United States as Goode Health Ultimate Wellness Blend for:

• General health and wellness
• Nutritional supplementation

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

Findings from Research

In a study of 85 aged care residents on texture-modified diets, those consuming oral nutritional supplements (ONS) had significantly higher intakes of energy, protein, carbohydrates, and fat compared to those not receiving ONS, indicating that ONS can enhance nutritional intake.

Despite the benefits of ONS, many residents still did not meet their overall energy and carbohydrate needs, highlighting the ongoing risk of malnutrition in this population, with 48% at risk and 38% already malnourished.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Dietary Intake and Nutritional Status between Aged Care Residents Consuming Texture-Modified Diets with and without Oral Nutritional Supplements. Wu, XS., Yousif, L., Miles, A., et al.[2023]

Oral nutrition supplements (ONS) are commonly used to help manage weight loss in older adults, but many are ultra-processed and may not provide the same health benefits as less-processed, plant-based foods.

Long-term reliance on ultra-processed ONS could negatively impact gut health by displacing fiber-rich, plant-sourced foods that support a diverse microbiota, potentially leading to gastrointestinal issues and reduced appetite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommending ultra-processed oral nutrition supplements for unintentional weight loss: Are there risks? Rivero-Mendoza, D., Caldwell, CL., Cooper, H., et al.[2023]

The study involved 144 hospital patients, with 62 receiving fortified food and snacks that provided an additional 22.2g of protein and 966 kcal per day, significantly increasing energy intake (P = 0.007).

Fortified food particularly benefited patients with the lowest energy intake, effectively addressing energy deficits and suggesting that this approach could enhance nutritional support in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of providing fortified meals and between-meal snacks on energy and protein intake of hospital patients. Gall, MJ., Grimble, GK., Reeve, NJ., et al.[2019]

In a 16-week study involving 71 healthy older adults, the addition of a liquid nutrition supplement significantly increased nutrient intake, particularly protein, calcium, iron, magnesium, and folate, without changing body mass index or overall energy intake.

Participants in the supplemented group reported improvements in perceived quality of life, specifically in vitality and general health perception, suggesting that the supplement may enhance well-being among elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjectively healthy elderly consuming a liquid nutrition supplement maintained body mass index and improved some nutritional parameters and perceived well-being. Krondl, M., Coleman, PH., Bradley, CL., et al.[2013]

Patients identified as undernourished during their hospital stay experience longer hospitalizations (1.4 days more), increased complications, and higher costs, highlighting the importance of addressing nutritional needs.

A new in-hospital meal service improved protein and energy intake among patients, but only 24% achieved adequate protein intake, indicating ongoing challenges in enhancing nutrition in hospitalized patients due to factors like illness-related appetite loss and insufficient nutritional awareness among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Undernourished in hospital]. Jonkers, CF., Soeters, MR.[2019]

Health foods, including dietary supplements, can pose significant safety risks, with reports of serious adverse events like liver and renal failure, and even death, due to undeclared ingredients and toxic compounds.

Specific products, such as 'OxyElite Pro', have been linked to severe liver damage and hepatitis, highlighting the dangers of unregulated health foods, especially those purchased online from overseas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current Problems Associated with Overseas Health Products]. Toda, M., Uneyama, C.[2019]

A study analyzing 110 reports of adverse reactions to herbal dietary supplements in Italy found that 23 serious reactions occurred, with 21 requiring hospitalization, highlighting significant safety concerns regarding these products.

Dermatological and cardiovascular issues were the most common reactions, and 9 out of 10 serious hepatic reactions were reported, indicating that the quality and supervision of these supplements are critical for consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. Ippoliti, I., Menniti-Ippolito, F., Mazzanti, G., et al.[2021]

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

The Canadian adverse event reporting system for herbal products is severely underreported, leading to a lack of safety data, which poses risks to consumers who often perceive these products as safe.

Health food store personnel in the Greater Toronto Area play a crucial role in reporting adverse reactions by collecting customer information during product returns, suggesting a potential pathway to improve safety monitoring and reporting for herbal products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. Walji, R., Boon, H., Barnes, J., et al.[2021]

A study analyzing 64 reports involving 71 patients found that liver dysfunction symptoms were primarily associated with the use of health foods alongside high-risk medications like antiepileptics and antineoplastics.

There is a lack of detailed information in journal articles regarding the specific ingredients of health foods, which complicates the understanding of potential interactions with conventional drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Notable Adverse Events Associated with Concomitant Use of Health Foods and Drugs Derived from the Analysis of HFNet Data on the Safety and Effectiveness of Health Foods]. Kojima, A., Sato, Y., Chiba, T., et al.[2019]

A diet supplemented with GrandFusion(®), which contains nutrients from whole fruits and vegetables, significantly protected mice from brain damage and improved neurological outcomes after induced ischemia.

The supplementation reduced inflammation and oxidative stress in the brain without affecting vital signs like heart rate and blood pressure, highlighting its potential as a neuroprotective dietary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplementation of GrandFusion(®) mitigates cerebral ischemia-induced neuronal damage and attenuates inflammation. Yu, J., Zhu, H., Gattoni-Celli, S., et al.[2017]

Matcha green tea is rich in bioactive ingredients and has strong antioxidant properties, making it beneficial for health, particularly in its powdered form for easy consumption.

A new functional beverage made from Matcha, protein, inulin, and other ingredients has been developed, offering regenerative benefits and prebiotic properties, making it suitable for athletes, the elderly, and those with specific nutritional deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Content of Bioactive Compounds and Technological Properties of Matcha Green Tea and Its Application in the Design of Functional Beverages. Najman, K., Sadowska, A., Wolińska, M., et al.[2023]

Health drinks in Japan, classified into drink tonics (100 ml) and mini-drink tonics (50 ml or less), have evolved since before World War II and became popular in the 1960s due to changes in lifestyle and health awareness.

The introduction of dose-glassed liquids improved the stability and ease of consumption of these health drinks, leading to significant market growth, with sales reaching about 200 billion yen by 1991, highlighting their importance in the economic foundation of drug stores in Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The historic study on the health drink-especially on the origin of health drink and the formation of its market-]. Ohe, H., Harima, S., Matsumoto, Y.[2015]

A new beverage made from powdered whole milk and precooked rice flour was developed, showing a strong nutritional profile with 423 kcal, 11g of protein, and essential vitamins and minerals, making it a good option for nutritional protection programs in Venezuela.

The beverage demonstrated good stability, lasting up to seven months at cooler temperatures (5°C and 27°C), which supports its potential use in preventing undernutrition in the population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Formulation and evaluation of a beverage based on whole milk and precooked rice flour]. Guaipo, B., Calderón, M., Laprea, MT.[2016]

A reformulated Margherita pizza was developed to meet nutritional guidelines, providing 30% of daily energy needs while ensuring all nutrients are within recommended ranges, including reduced sodium and saturated fat levels.

In taste tests, 77% of adults and 81% of children rated the nutritionally balanced pizza as 'as good as' or 'better than' their usual pizza, demonstrating that healthier options can be appealing without changing eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a nutritionally balanced pizza as a functional meal designed to meet published dietary guidelines. Combet, E., Jarlot, A., Aidoo, KE., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Comparison of Dietary Intake and Nutritional Status between Aged Care Residents Consuming Texture-Modified Diets with and without Oral Nutritional Supplements. [2023]

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

Recommending ultra-processed oral nutrition supplements for unintentional weight loss: Are there risks? [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effect of providing fortified meals and between-meal snacks on energy and protein intake of hospital patients. [2019]

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

Subjectively healthy elderly consuming a liquid nutrition supplement maintained body mass index and improved some nutritional parameters and perceived well-being. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Undernourished in hospital]. [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

[Current Problems Associated with Overseas Health Products]. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. [2021]

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

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

9. Canada pubmed.ncbi.nlm.nih.gov

Adverse event reporting for herbal medicines: a result of market forces. [2021]

10. Japan pubmed.ncbi.nlm.nih.gov

[Notable Adverse Events Associated with Concomitant Use of Health Foods and Drugs Derived from the Analysis of HFNet Data on the Safety and Effectiveness of Health Foods]. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Dietary supplementation of GrandFusion(®) mitigates cerebral ischemia-induced neuronal damage and attenuates inflammation. [2017]

12. Switzerland pubmed.ncbi.nlm.nih.gov

The Content of Bioactive Compounds and Technological Properties of Matcha Green Tea and Its Application in the Design of Functional Beverages. [2023]

13. Japan pubmed.ncbi.nlm.nih.gov

[The historic study on the health drink-especially on the origin of health drink and the formation of its market-]. [2015]

14. Venezuela pubmed.ncbi.nlm.nih.gov

[Formulation and evaluation of a beverage based on whole milk and precooked rice flour]. [2016]

15. England pubmed.ncbi.nlm.nih.gov

Development of a nutritionally balanced pizza as a functional meal designed to meet published dietary guidelines. [2023]