High-Soluble Fiber Diet for Sarcopenia

Overseen By Michael S Lustgarten, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Must not be taking: Probiotics, Antibiotics, Immunosuppressants, Corticosteroids

Disqualifiers: Malnutrition, Diabetes, Chronic kidney disease, others

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

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

Muscle health declines during aging. One factor that may impact muscle health is the community of bacteria that live in our intestines, but studies aimed at improving muscle health by targeting the gut in older adults are sparse. The primary goal of this study is to use a diet that is enriched in soluble fiber, which is exclusively utilized by gut bacteria to make substances that can impact muscle health, to improve muscle-related measures in older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use antibiotics or change your medication routine within one month before starting the study. Chronic use of anti-inflammatory medication is also not allowed.

What data supports the effectiveness of a high-soluble fiber diet treatment for sarcopenia?

Research suggests that certain dietary patterns, like those high in dietary fiber, are associated with better muscle function and lower risk of sarcopenia. A study found that a diet rich in nutrients, including dietary fiber, was linked to improved muscle strength and physical performance. ^{1 2 3 4 5}

Is a high-soluble fiber diet safe for humans?

High-soluble fiber diets are generally safe for humans, but consuming too much fiber, especially from supplements, can cause issues like intestinal blockage and reduced nutrient absorption. Including fiber-rich foods like fruits, vegetables, and whole grains in your diet is usually safe and beneficial. ^{6 7 8 9 10}

How does a high-soluble fiber diet treatment for sarcopenia differ from other treatments?

A high-soluble fiber diet is unique because it focuses on increasing dietary fiber intake, which may help improve muscle health by promoting gut health and reducing inflammation, unlike other treatments that might focus on protein intake or physical activity. ^{2 3 5 11 12}

Research Team

Michael S Lustgarten, PhD

Principal Investigator

Scientist II, NEPS Laboratory

Eligibility Criteria

This trial is for non-smoking, English-speaking older adults over 65 who live independently and lead a sedentary lifestyle. They should be free of gastrointestinal diseases, willing to eat high-soluble fiber foods without major dietary restrictions or allergies, and not planning significant weight changes or medical procedures that could affect the study.

Inclusion Criteria

Willing to consume an abundance of fruits, vegetables, nuts/seeds

I am over 65 years old and live independently.

Fluent in English

Exclusion Criteria

I have diabetes and use insulin.

I am currently taking drugs that suppress my immune system.

Unwilling to only consume the provided food (unsweetened tea and/or black coffee are allowed)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to consume a high- or low-soluble fiber diet for 12 weeks

12 weeks

Baseline and week-13 visits

Follow-up

Participants are monitored for changes in muscle-related measures and gut bacterial metabolites

4 weeks

Treatment Details

Interventions

• High-soluble fiber diet
• Low-soluble fiber diet

Trial Overview The study tests how diets with different levels of soluble fiber affect gut bacteria and muscle health in older adults. Participants will follow either a low-soluble fiber diet or a high-soluble fiber diet for 13 weeks to see if there's an impact on their muscle-related measures.

Participant Groups

Group I: Low-soluble fiber diet Experimental Treatment 1 Intervention

Group II: High-soluble fiber diet Active Control 1 Intervention

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Findings from Research

A systematic review of 14 studies involving older adults found that following the Mediterranean and Nordic diets is associated with a reduced risk of sarcopenia, which is the loss of muscle mass and strength as people age.

Conversely, diets high in saturated fats, typical of Western eating patterns, are linked to an increased risk of sarcopenia, highlighting the importance of diet quality in maintaining muscle health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Diet Quality and Sarcopenia in Older Adults: Systematic Review of Prospective Cohort Studies. Jang, EH., Han, YJ., Jang, SE., et al.[2021]

In a study of 300 elderly adults in Iran, a dietary pattern rich in anti-inflammatory nutrients was linked to significantly lower odds of sarcopenia and low muscle strength, suggesting that certain nutrient intakes can help maintain muscle health.

Adherence to a carbohydrate-rich dietary pattern was also associated with a reduced risk of low gait speed, indicating that specific nutrient patterns may play a role in preventing mobility issues in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of Nutrient Intake in Relation to Sarcopenia and Its Components. Bagheri, A., Hashemi, R., Heshmat, R., et al.[2023]

Higher adherence to the Baltic Sea diet (BSD) and Mediterranean diet (MED) is associated with less loss of muscle mass and better physical function in elderly women over a 3-year period, based on a study of 554 women aged 65-72.

Women with higher BSD and MED scores demonstrated greater lean mass, faster walking speeds, and better performance in physical tests, suggesting that improved diet quality may help reduce the risk of sarcopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of the Baltic Sea and Mediterranean diets with indices of sarcopenia in elderly women, OSPTRE-FPS study. Isanejad, M., Sirola, J., Mursu, J., et al.[2018]

In a study of 666 elderly individuals in Japan, adherence to the Japanese Food Guide Spinning Top (JFG-ST) diet was positively associated with higher skeletal mass index (SMI), particularly in men, suggesting that this dietary pattern may help prevent sarcopenia.

No significant associations were found between dietary patterns and muscle strength or walking speed, indicating that while diet can influence muscle mass, it may not directly affect other aspects of physical performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Patterns and Muscle Mass, Muscle Strength, and Physical Performance in the Elderly: A 3-Year Cohort Study. Huang, CH., Okada, K., Matsushita, E., et al.[2021]

In a study of 65 obese older adults, adherence to a Mediterranean Diet did not show a significant association with a reduced risk of sarcopenic symptoms, such as low muscle strength or poor physical performance.

The findings suggest that while the Mediterranean Diet is generally healthy, it may not directly prevent sarcopenia in this population, indicating a need for further research on dietary interventions to address sarcopenic symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean Diet Is Not Associated with Risk of Sarcopenic Symptomology: A Cross-Sectional Analysis of Overweight and Obese Older Adults in Australia. Stanton, A., Buckley, J., Villani, A.[2019]

In a study involving Sprague-Dawley rats fed soluble soybean fiber (SSF) at concentrations up to 40,000 ppm for three months, the NOAEL (no-observed-adverse-effect level) was determined to be 40,000 ppm, indicating that SSF is safe for consumption at this level.

While initial weight gain and food intake decreased due to increased intestinal throughput, the rats adapted over time, showing improved weight gain and food consumption, suggesting that SSF can be tolerated and may have beneficial effects on cholesterol levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble soybean fiber: a 3-month dietary toxicity study in rats. Takahashi, T., Nakamura, A., Kato, M., et al.[2023]

Epidemiologic studies indicate that a higher intake of dietary fiber is associated with a reduced risk of coronary heart disease (CHD), leading to new recommendations of 38 g/d for young men and 25 g/d for young women.

Fiber may protect against CHD through various mechanisms, including lowering cholesterol and triglyceride levels, reducing hypertension, and stabilizing blood glucose levels, emphasizing the importance of total fiber intake rather than just focusing on soluble fiber.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber and coronary disease: does the evidence support an association? Lupton, JR., Turner, ND.[2019]

A study involving obese adult patients in western China showed that a diet high in soluble dietary fibers (SDFs) led to significant reductions in weight, body mass index (BMI), body fat rate (BFR), and waistline over a 3-week period.

The reductions in these obesity-related measurements were significantly greater in the SDF group compared to a control group, suggesting that increasing SDF intake can effectively help in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soluble Dietary Fiber Significance against Obesity in a Western China Population. Tang, Q., Ma, B., Zhao, Y., et al.[2023]

Most research on dietary fiber effects comes from adult studies, indicating that excessive intake of isolated fibers or nonpurified supplements can lead to issues like intestinal obstruction and reduced nutrient absorption.

Including natural fiber-rich foods like fruits, vegetables, and whole grains in children's diets is essential for meeting fiber intake recommendations, but portion sizes should be smaller than those for adults to prevent appetite suppression and ensure a balanced diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fiber. Schneeman, BO., Tinker, LF.[2019]

In a study of 189 adults with fecal incontinence, fiber supplementation was generally well tolerated, with minimal gastrointestinal symptoms reported across all groups, indicating safety in using dietary fiber supplements.

The only significant symptom difference was a greater feeling of fullness in the psyllium group compared to placebo, and higher symptom severity was linked to emotional upset, which influenced participants' likelihood to withdraw or reduce their fiber dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptoms associated with dietary fiber supplementation over time in individuals with fecal incontinence. Bliss, DZ., Savik, K., Jung, HJ., et al.[2021]

In a study of 1618 older adults with sarcopenia, those who were physically active had a 25% lower risk of mortality compared to sedentary individuals, highlighting the importance of physical activity in this population.

Older adults with sarcopenia who maintained good diet quality had a 45% lower risk of death compared to those with poor diet quality, indicating that a healthy diet significantly contributes to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, diet quality, and mortality among sarcopenic older adults. Brown, JC., Harhay, MO., Harhay, MN.[2018]

In a study of 861 older adults in China, a dietary pattern rich in mushrooms, fruits, and milk was found to be negatively associated with sarcopenia, suggesting it may help protect against this condition.

The study indicated that higher protein intake and lower energy percentage from fat (less than 30%) were linked to reduced risk of sarcopenia, highlighting the importance of both protein and dietary fat composition in managing this age-related muscle loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Pattern and Dietary Energy from Fat Associated with Sarcopenia in Community-Dwelling Older Chinese People: A Cross-Sectional Study in Three Regions of China. Li, C., Kang, B., Zhang, T., et al.[2023]

References

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

Association between Diet Quality and Sarcopenia in Older Adults: Systematic Review of Prospective Cohort Studies. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Patterns of Nutrient Intake in Relation to Sarcopenia and Its Components. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Association of the Baltic Sea and Mediterranean diets with indices of sarcopenia in elderly women, OSPTRE-FPS study. [2018]

4. France pubmed.ncbi.nlm.nih.gov

Dietary Patterns and Muscle Mass, Muscle Strength, and Physical Performance in the Elderly: A 3-Year Cohort Study. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Adherence to a Mediterranean Diet Is Not Associated with Risk of Sarcopenic Symptomology: A Cross-Sectional Analysis of Overweight and Obese Older Adults in Australia. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Soluble soybean fiber: a 3-month dietary toxicity study in rats. [2023]

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

Dietary fiber and coronary disease: does the evidence support an association? [2019]

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

Soluble Dietary Fiber Significance against Obesity in a Western China Population. [2023]

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

Dietary fiber. [2019]

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

Symptoms associated with dietary fiber supplementation over time in individuals with fecal incontinence. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Physical activity, diet quality, and mortality among sarcopenic older adults. [2018]

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

Dietary Pattern and Dietary Energy from Fat Associated with Sarcopenia in Community-Dwelling Older Chinese People: A Cross-Sectional Study in Three Regions of China. [2023]