Greens-Based Supplement for Aging

Overseen By Laura Robinson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Disqualifiers: Cardiometabolic diseases, Cancer, Food allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to assess changes in epigenetic markers of aging and physiological parameters in overweight older adults consuming a mixed greens-based supplement over a 30-day period in a randomized crossover design.

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

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

What data supports the idea that Greens-Based Supplement for Aging is an effective treatment?

The available research does not provide specific data on the effectiveness of Greens-Based Supplement for Aging. Instead, it discusses the use of oral nutritional supplements in general, particularly in community settings and nursing homes. These studies focus on liquid nutrition supplements and their effects on weight, nutrient intake, and perceived well-being. However, they do not specifically address Greens-Based Supplements or compare them to other treatments for aging. Therefore, there is no direct evidence from the provided research to support the effectiveness of Greens-Based Supplement for Aging. ^{1 2 3 4 5}

What safety data exists for greens-based supplements?

The safety data for greens-based supplements, including those under names like Greens Powder or Superfood Supplement, is limited and often complicated by inconsistent reporting and ingredient variability. Some studies have highlighted potential adverse effects associated with herbal ingredients commonly found in such supplements, like liver toxicity linked to green tea extracts. The United States Pharmacopeia has reviewed green tea extracts and found that hepatotoxicity can occur, especially when consumed on an empty stomach. Adverse effects are more likely in elderly patients or those taking multiple medications. Clinicians are advised to report any suspected adverse effects to health authorities. Overall, while some safety concerns exist, they are often related to specific ingredients and usage conditions. ^{6 7 8 9 10}

Is the Greens-based Supplement a promising treatment for aging?

Yes, the Greens-based Supplement is promising for aging because it contains nutrients that can improve health and well-being. It may help maintain body weight, improve nutritional intake, and enhance quality of life. Additionally, it has antioxidant properties that can protect cells and support a longer, healthier life. ^{4 5 11 12 13}

Research Team

MIchael D Roberts, PhD

Principal Investigator

Auburn University

Eligibility Criteria

This trial is for overweight older adults with a BMI over 30 who don't eat many dark green leafy vegetables. Participants must be postmenopausal women or men, able to communicate in English and use smartphone technology. People with recent transient ischemic attacks, cancer (except certain skin cancers), food allergies, or serious heart and metabolic conditions cannot join.

Inclusion Criteria

I am a man or a postmenopausal woman.

My BMI is over 30.

Low habitual dark green leafy vegetable consumption

Exclusion Criteria

I had a mini-stroke within the last 6 months.

I was diagnosed with cancer, other than minor skin cancers, within the last 5 years.

Food allergies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants consume the greens-based supplement for 30 days

4 weeks

1 visit (in-person) at baseline, 1 visit (in-person) at day 30

Crossover Phase

Participants switch to a free-living/non-supplementation setting for 30 days

4 weeks

1 visit (in-person) at day 60

Follow-up

Participants are monitored for changes in epigenetic markers and physiological parameters

4 weeks

1 visit (in-person) at day 60

Treatment Details

Interventions

• Greens-based Supplement

Trial Overview The study tests if a greens-based supplement can improve markers of aging in the body over 30 days using a randomized crossover design. This means participants will receive both the supplement and no supplement at different times to compare effects.

Participant Groups

Group I: Immediate supplementation Experimental Treatment 1 Intervention

Participant will consume greens-based supplement for 30 days after which they will crossover into a free-living/non-supplementation setting for 30 days.

Group II: Delayed supplementation Experimental Treatment 1 Intervention

Participants will consume greens-based supplement for 30 days after living their normal lives (free-living) for 30 days.

Greens-based Supplement is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Greens-Based Supplement for:

• Dietary Supplement for General Health and Wellness

Approved in European Union as Greens-Based Supplement for:

• Food Supplement for General Health and Wellness

Approved in Canada as Greens-Based Supplement for:

• Natural Health Product for General Health and Wellness

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Brickhouse Nutrition

Collaborator

Trials

1

Recruited

20+

Findings from Research

A systematic review of 84 trials indicates that oral nutritional supplements may provide benefits for patients with chronic conditions in community settings, although consensus on their overall effectiveness is still lacking.

The review highlights the need for further research to better understand the specific benefits and optimal use of nutritional supplements across various diseases and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are oral nutritional supplements of benefit to patients in the community? Findings from a systematic review. Stratton, RJ., Elia, M.[2022]

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]

In a study of 40 nursing home residents who were not eating well, only 9 out of 29 residents received the correct dietary supplements as prescribed, and only 2 consumed the full amount, indicating significant issues with administration and adherence.

Despite the intention to prevent weight loss, nearly half of the residents continued to lose weight, suggesting that the use of supplements was not effectively addressing the underlying causes of poor nutrition, such as inadequate staffing and undiagnosed swallowing difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective study of the use of liquid oral dietary supplements in nursing homes. Kayser-Jones, J., Schell, ES., Porter, C., et al.[2019]

The multinutrient liquid nutrition supplement was well accepted by psycho-geriatric nursing home patients, leading to a significant increase in body weight by an average of 2.2 kg over 12 weeks compared to the placebo group.

Patients receiving the supplement also showed improvements in several plasma nutrient levels, including vitamin B1, B6, B12, folate, and vitamin D, indicating enhanced nutritional status without any significant increase in gastrointestinal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of the effect of a liquid nutrition supplement on the nutritional status of psycho-geriatric nursing home patients. Wouters-Wesseling, W., Wouters, AE., Kleijer, CN., et al.[2022]

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]

The systematic review found that while green tea extracts (GTE) can contain potentially harmful substances, there was no direct evidence linking these contaminants to liver injury, although hepatotoxicity has been associated with high doses of EGCG (140 mg to 1000 mg/day).

Due to the risk of liver injury, the United States Pharmacopeia now recommends that GTE should not be taken on an empty stomach and advises against use in individuals with liver problems, highlighting the importance of taking GTE with food and monitoring for symptoms of liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts. Oketch-Rabah, HA., Roe, AL., Rider, CV., et al.[2020]

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]

Adverse effects from dietary supplements typically resolve quickly after stopping the product, but elderly patients or those on multiple medications are at higher risk for complications, especially with drugs that interact with cytochrome P450 enzymes.

Clinicians should routinely ask patients about their use of herbal and dietary supplements when prescribing new medications or evaluating new symptoms, and report any suspected adverse effects to health authorities to improve safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Effects of Common Drugs: Dietary Supplements. Felix, TM., Karpa, KD., Lewis, PR.[2015]

A systematic review of 216 case reports on green tea products revealed 34 instances of liver damage, with 27 categorized as possible and 7 as probable causality, raising safety concerns about concentrated green tea extracts.

The review indicated that taking green tea extracts on an empty stomach increases the risk of adverse effects, but when used appropriately, these products can be considered safe for development into official monographs, provided they include cautionary labeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of green tea extracts : a systematic review by the US Pharmacopeia. Sarma, DN., Barrett, ML., Chavez, ML., et al.[2021]

Over 70% of Americans use dietary supplements daily, yet these products are not required to be approved by the FDA before being sold, leading to potential safety concerns.

While many supplements are widely consumed, there is limited evidence supporting their health benefits in well-nourished adults, and some can cause significant toxicity or interact negatively with prescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Effects of Nutraceuticals and Dietary Supplements. Ronis, MJJ., Pedersen, KB., Watt, J.[2020]

Cellular senescence plays a significant role in aging and disease, and targeting senescent cells could enhance healthspan and lifespan.

Dietary elements, including carbohydrates, proteins, fatty acids, vitamins, and polyphenols, have been shown to influence cellular senescence, suggesting that nutrition can be a key factor in managing aging and promoting longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional components as mitigators of cellular senescence in organismal aging: a comprehensive review. Diwan, B., Sharma, R.[2022]

A 12-week intervention combining a hyperproteic, hypercaloric oral nutritional supplement with prebiotic fiber, vitamin D, and calcium, along with a standardized physical exercise program, significantly improved functional status, nutritional status, and quality of life in 91 frail older adults living in nursing homes.

Improvements were noted in physical performance (measured by the Short Physical Performance Battery) and quality of life (measured by the EuroQoL-5 Dimensions scale), with over 50% of participants showing functional improvements by week 12, particularly those with greater frailty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an Oral Nutritional Supplementation Plus Physical Exercise Intervention on the Physical Function, Nutritional Status, and Quality of Life in Frail Institutionalized Older Adults: The ACTIVNES Study. Abizanda, P., López, MD., García, VP., et al.[2022]

A novel composition of plant extracts was developed that targets multiple hallmarks of aging, showing promising results in increasing cellular lifespan and enhancing antioxidant defenses in both cell cultures and living organisms.

In a 3-month randomized controlled trial with healthy volunteers, this combination significantly improved antioxidant capacity, suggesting that such natural compound interventions can effectively enhance healthspan and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antioxidant and Antiaging Properties of a Novel Synergistic Nutraceutical Complex: Readouts from an In Cellulo Study and an In Vivo Prospective, Randomized Trial. Athanasopoulou, S., Kapetanou, M., Magouritsas, MG., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Are oral nutritional supplements of benefit to patients in the community? Findings from a systematic review. [2022]

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

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

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

A prospective study of the use of liquid oral dietary supplements in nursing homes. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Study of the effect of a liquid nutrition supplement on the nutritional status of psycho-geriatric nursing home patients. [2022]

5. 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]

6. Ireland pubmed.ncbi.nlm.nih.gov

United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts. [2020]

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

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

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

Adverse Effects of Common Drugs: Dietary Supplements. [2015]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of green tea extracts : a systematic review by the US Pharmacopeia. [2021]

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

Adverse Effects of Nutraceuticals and Dietary Supplements. [2020]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Nutritional components as mitigators of cellular senescence in organismal aging: a comprehensive review. [2022]

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

Effects of an Oral Nutritional Supplementation Plus Physical Exercise Intervention on the Physical Function, Nutritional Status, and Quality of Life in Frail Institutionalized Older Adults: The ACTIVNES Study. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Antioxidant and Antiaging Properties of a Novel Synergistic Nutraceutical Complex: Readouts from an In Cellulo Study and an In Vivo Prospective, Randomized Trial. [2022]