Animal vs Plant Protein for Menopause

Overseen By Amanda Gwin, PA-C

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Must not be taking: Anti-inflammatories, Metabolism-altering drugs

Disqualifiers: Musculoskeletal injuries, Metabolic diseases, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether animal-based protein foods are more effective than plant-based ones in improving muscle health and reducing inflammation in postmenopausal women. Participants will consume either plant or animal protein meals to assess effectiveness. Women who have not menstruated for at least a year and have a BMI between 20 and 34.9 may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on health.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. Specifically, you must stop using anti-inflammatory drugs for a week before and during the study, and you must suspend anti-clotting medications, including aspirin, for 5 days before a specific visit.

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

Research has shown that plant-based diets are generally safe for women after menopause. One study found no increased risk of hip fractures in these women. Plant proteins also seem to promote healthier aging and might reduce the risk of early death from heart disease and dementia.

Conversely, the effects of meals high in animal protein are mixed. Some studies suggest that consuming large amounts of animal protein might accelerate bone loss and increase fracture risk. However, evidence also indicates that protein intake, in general, supports healthy aging.

In conclusion, both plant and animal proteins have been studied for their health effects, each offering pros and cons. While there are no major safety concerns, it's important to consider how different protein sources might impact overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore how different protein sources might affect menopause symptoms, which is a novel approach compared to current treatments like hormone replacement therapy and lifestyle changes. Unlike the standard of care, which often involves medication, these treatments focus on dietary changes, examining meals based on plant or animal protein. This dietary approach could offer a natural, non-pharmaceutical option for managing menopause symptoms, potentially minimizing side effects associated with traditional treatments. Additionally, the study could reveal insights into how protein sources impact body weight and composition, which are important factors for many experiencing menopause.

What evidence suggests that this trial's treatments could be effective for menopause?

This trial will compare the effects of plant-based protein meals with those of animal-based protein meals for women at different stages of menopause. Research has shown that plant-based diets, especially those with soy, can benefit women after menopause. Studies have found that replacing animal products with plant-based foods can reduce moderate-to-severe hot flashes by up to 92%. These diets are also linked to weight loss and improved body shape.

Conversely, animal protein offers its own benefits. Research suggests that consuming more protein, such as 1.2 grams per kilogram of body weight, can lower the risk of frailty by 32% in older women. Animal proteins may also help maintain bone strength, which is important during menopause. Each type of protein offers different benefits, making both worth considering for various health goals. Participants in this trial will be assigned to different arms based on their menopausal status and BMI, receiving meals primarily consisting of either plant or animal protein sources. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for premenopausal women aged 35-45 and postmenopausal women aged 50-65 with a BMI of 20.0 - 34.9 kg/m2, who are not currently pregnant or have given birth in the past year, without metabolic or hormonal diseases, significant weight changes, or on certain medications that affect metabolism.

Inclusion Criteria

BMI of 20.0 - 34.9 kg/m2

I am a woman aged 50-65 and have not had a period for at least 12 months.

I am a woman aged 35-45 and have had regular periods for the last year.

Exclusion Criteria

I have had weight loss surgery.

I cannot stop taking my blood thinners, including aspirin, for 5 days.

My weight has changed by more than 5% in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume either beef or isonitrogenous plant-based protein sources for 5 consecutive days

5 days

Follow-up

Participants are monitored for changes in muscle protein synthesis and inflammatory markers

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Meals consisting of plant protein sources
• Meals consisting of primarily animal protein sources

Trial Overview The study aims to compare the effects of meals rich in animal protein versus plant protein on muscle health and inflammation in pre- and postmenopausal women by randomly assigning participants to one of the two diet types.

How Is the Trial Designed?

Group I: postmenopausal with obese BMI that eats vegetables as their protein source in study meals Experimental Treatment 1 Intervention

Group II: postmenopausal with obese BMI that eats primarily beef as their protein source in study meals Experimental Treatment 1 Intervention

Group III: postmenopausal with normal/overweight BMI that eats vegetables as their protein source Experimental Treatment 1 Intervention

Group IV: postmenopausal with normal/overweight BMI that eats primarily beef as their protein source Experimental Treatment 1 Intervention

Group V: premenopausal with normal/overweight BMI that eats primarily beef as their protein source Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

In a study of 960 older adults, higher intake of animal protein was positively associated with increased bone mineral density (BMD), particularly in women, suggesting it may help protect against osteoporosis.

Conversely, higher vegetable protein intake was negatively associated with BMD in both men and women, indicating that not all protein sources have the same effects on bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein consumption and bone mineral density in the elderly : the Rancho Bernardo Study. Promislow, JH., Goodman-Gruen, D., Slymen, DJ., et al.[2019]

A daily intake of 25 g of soy protein can significantly lower total cholesterol and LDL cholesterol levels, contributing to a reduced risk of coronary heart disease, as supported by various studies.

Soy isoflavones may have protective effects on breast tissue and do not show adverse effects in humans, but more randomized clinical trials are needed to confirm their role in hormone replacement therapy and other health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soy isoflavones: are they useful in menopause? Vincent, A., Fitzpatrick, LA.[2023]

Canadian adults who consumed more than 50% of their protein from plant sources had higher intakes of beneficial nutrients like dietary fiber, folate, iron, and magnesium, but lower intakes of total and saturated fat, vitamin D, and vitamin B12.

A balanced diet that includes both plant and animal protein sources leads to better overall nutrient quality compared to diets that are heavily focused on either animal or plant proteins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of contributions of animal- and plant-based dietary patterns on the nutrient quality of diets of adult Canadians. Fabek, H., Sanchez-Hernandez, D., Ahmed, M., et al.[2022]

In a study of 10,977 US adults, it was found that 46% of protein intake came from animal sources, 16% from dairy, and 30% from plant sources, highlighting the current distribution of protein consumption in the American diet.

The primary sources of protein were identified as chicken and beef for animal protein, cheese and reduced-fat milk for dairy, and yeast breads and nuts for plant protein, providing a baseline for future public health interventions aimed at improving protein quality in diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sources and Amounts of Animal, Dairy, and Plant Protein Intake of US Adults in 2007-2010. Pasiakos, SM., Agarwal, S., Lieberman, HR., et al.[2018]

Soybeans are a complete protein source that can lower cholesterol levels and may help reduce the risk of certain cancers, particularly in populations with high soy and low animal protein diets.

Dietary whole soy protein is well tolerated and beneficial for health, but refined soy isoflavone supplements do not provide the same positive effects, and more research is needed for recommendations regarding soy intake in women with a history of breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soy: a complete source of protein. Michelfelder, AJ.[2018]

In a study of 15 healthy premenopausal women over 9 months, consuming 60 g of textured vegetable protein (TVP) with 45 mg of conjugated isoflavones significantly increased the length of the follicular phase and delayed peak progesterone concentrations.

The intake of 45 mg of conjugated isoflavones also suppressed mid-cycle peaks of luteinizing hormone (LH) and follicle stimulating hormone (FSH), while a significant reduction in total cholesterol was observed, indicating potential hormonal and cardiovascular benefits from isoflavone consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological effects of isoflavones in young women: importance of the chemical composition of soyabean products. Cassidy, A., Bingham, S., Setchell, K.[2023]

In a 20-year study of 1,139 older adults, higher intake of animal protein was linked to lower all-cause and cardiovascular mortality, suggesting it may have protective health benefits for this age group.

Plant protein intake did not show a direct association with mortality outcomes, but its effects varied based on the presence of hypertension, indicating that individual health conditions may influence dietary impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animal Protein Intake Is Inversely Associated With Mortality in Older Adults: The InCHIANTI Study. Meroño, T., Zamora-Ros, R., Hidalgo-Liberona, N., et al.[2022]

Soy foods, rich in protein and isoflavones, have been shown to improve muscle and bone density in postmenopausal women, which is crucial for preventing conditions like osteosarcopenia.

Incorporating soy into the diet can also help reduce body weight, making it a beneficial dietary choice for managing body composition changes associated with menopause.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Soy Foods in Postmenopausal Women: A Focus on Osteosarcopenia and Obesity. Tang, S., Du, Y., Oh, C., et al.[2020]

In a one-year study involving 87 postmenopausal women, daily consumption of soy protein (25 g) and isoflavones did not prevent bone loss in the lumbar region and whole body, despite positive effects on markers of bone formation.

Both soy and control groups showed increased levels of bone formation markers, but neither treatment affected bone resorption, indicating that while soy may support bone health, it does not stop the decline in bone density in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One year soy protein supplementation has positive effects on bone formation markers but not bone density in postmenopausal women. Arjmandi, BH., Lucas, EA., Khalil, DA., et al.[2022]

Combining both plant and animal protein with physical activity is most effective for improving bone health and reducing fall risk, while high protein intake can be harmful during periods of inactivity, such as bed rest.

Plant protein, despite containing isoflavones, does not provide greater benefits for bone health compared to animal protein, and can even lead to increased bone resorption, highlighting the importance of a balanced diet for maintaining bone density, especially in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Dietary Protein on Osteoporosis Development. Kędzia, G., Woźniak, M., Samborski, W., et al.[2023]

In a study of 85,682 premenopausal women followed from 1991 to 2011, high intake of vegetable protein was linked to a 16% lower risk of early menopause compared to low intake, suggesting a protective effect of vegetable protein on reproductive health.

Specific foods like pasta, dark bread, and cold cereal were associated with a reduced risk of early menopause, while animal protein intake showed no relationship with this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Protein Intake and Early Menopause in the Nurses' Health Study II. Boutot, ME., Purdue-Smithe, A., Whitcomb, BW., et al.[2019]

Citations

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Replacing Animal Products With Plant-Based Foods Leads ... Replacing Animal Products With Plant-Based Foods Leads to 92% Reduction in Hot Flashes in Postmenopausal Women, Finds New Study.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8308420/

Nutrition in Menopausal Women: A Narrative Review - PMC In the Women's Health Initiative study, higher protein intake (1.2 g/kg body weight) was associated with a 32% lower risk of frailty and better ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4433492/

ADEQUATE DIETARY PROTEIN IS ASSOCIATED WITH ... In conclusion, we found that healthy, older postmenopausal women consumed, on average, 1.1 g/kg/d protein, although 25% consumed less than the RDA. Though the ...

4. mdpi.com mdpi.com/2673-9488/4/3/16

The Impact of Protein in Post-Menopausal Women on ... High intakes of plant-based protein have been associated with later onset of menopause [104] and reduced risk of type 2 diabetes, whereas a diet high in animal ...

5. withpower.com withpower.com/trial/animal-vs-plant-protein-for-menopause-5e845

Animal vs Plant Protein for Menopause · Info for Participants Studies have shown that plant proteins may lower the risk of early menopause and animal proteins may support bone health in older adults. Soy protein, a type of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10780928/

The Importance of Nutrition in Menopause and ... Diets with a high protein content (at least 20% of energy) only result in weight loss if the energy content is low. At the same time, ensuring the protein ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523662823

Dietary protein intake in midlife in relation to healthy aging A total of 3721 (7.6%) NHS participants met our healthy aging definition. Protein intake was significantly associated with higher odds of healthy aging.

8. everydayhealth.com everydayhealth.com/womens-health/diets-rich-in-plant-protein-tied-to-healthier-aging-in-women/

Diets Rich in Plant Protein Tied to Healthier Aging in Women Women who consumed the most plant proteins were 46 percent more likely to be healthy agers, while participants who ate the most animal protein ...

9. heart.org heart.org/en/news/2021/02/24/eating-more-plant-protein-less-red-meat-may-lower-womens-risk-of-early-death

Eating more plant protein, less red meat may lower ... Eating more plant protein and less red meat may lower a woman's risk of dying from dementia, heart disease and other causes, new research shows.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4045293/

Adverse Effects Associated with Protein Intake above the ... Moreover, a prospective cohort study showed that a high ratio of dietary animal to vegetable protein increases the rate of bone loss and the risk of fracture ...