Animal vs Plant Protein for Menopause
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arkansas
Must not be taking: Anti-inflammatories, Metabolism-altering drugs
Disqualifiers: Musculoskeletal injuries, Metabolic diseases, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This will be a randomized study to determine if animal-based protein-rich food sources can stimulate greater muscle protein turnover and whole-body protein balance and reduce skeletal muscle inflammatory markers in postmenopausal women compared to vegetarian base protein-rich foods.
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.
What data supports the effectiveness of meals consisting of plant or animal protein sources for menopause?
Research suggests that high vegetable protein intake may lower the risk of early menopause, while soy protein, a plant protein, may help with menopausal symptoms like hot flashes and maintaining bone density. Animal protein has been associated with better bone health in older women, which could be beneficial during menopause.
12345Is it safe to consume animal and plant proteins during menopause?
Research suggests that both animal and plant proteins are generally safe for human consumption. 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 plant protein, has been associated with reduced cholesterol levels and no known adverse effects in humans.
12467How does the treatment of meals with plant vs. animal protein differ for menopause?
This treatment is unique because it focuses on dietary changes, specifically comparing plant-based proteins like soy, which contain isoflavones that may improve muscle and bone health, to animal-based proteins. Unlike traditional hormone replacement therapies, this approach uses food as a natural intervention to potentially manage menopause symptoms and improve body composition.
3891011Eligibility Criteria
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.
+1 more
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.
+10 more
Trial Timeline
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
Participant Groups
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.
5Treatment groups
Experimental Treatment
Active Control
Group I: postmenopausal with obese BMI that eats vegetables as their protein source in study mealsExperimental Treatment1 Intervention
Group II: postmenopausal with obese BMI that eats primarily beef as their protein source in study mealsExperimental Treatment1 Intervention
Group III: postmenopausal with normal/overweight BMI that eats vegetables as their protein sourceExperimental Treatment1 Intervention
Group IV: postmenopausal with normal/overweight BMI that eats primarily beef as their protein sourceExperimental Treatment1 Intervention
Group V: premenopausal with normal/overweight BMI that eats primarily beef as their protein sourceActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Center of Translational Research in Aging and LongevityLittle Rock, AR
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Who Is Running the Clinical Trial?
University of ArkansasLead Sponsor
References
Protein consumption and bone mineral density in the elderly : the Rancho Bernardo Study. [2019]The role of dietary protein in osteoporosis is unclear, with previous studies having suggested both protection and harm. The associations of total, animal, and vegetable protein with bone mineral density (BMD) and the variations in these associations with calcium intake were studied in a community-dwelling cohort of 572 women and 388 men aged 55-92 years (Rancho Bernardo, California). Multiple linear regression analyses adjusted for standard osteoporosis covariates showed a positive association between animal protein consumption, assessed by food frequency questionnaires in 1988-1992, and BMD, measured 4 years later. This association was statistically significant in women. For every 15-g/day increase in animal protein intake, BMD increased by 0.016 g/cm2 at the hip (p = 0.005), 0.012 g/cm2 at the femoral neck (p = 0.02), 0.015 g/cm2 at the spine (p = 0.08), and 0.010 g/cm2 for the total body (p = 0.04). Conversely, a negative association between vegetable protein and BMD was observed in both sexes. Some suggestion of effect modification by calcium was seen in women, with increasing protein consumption appearing to be more beneficial for women with lower calcium intakes, but evidence for this interaction was not consistently strong. This study supports a protective role for dietary animal protein in the skeletal health of elderly women.
Dietary Protein Intake and Early Menopause in the Nurses' Health Study II. [2019]Early menopause, which is the cessation of ovarian function before age 45 years, affects 5%-10% of Western women and is associated with an increased risk of adverse health outcomes. Literature suggests that high levels of vegetable protein intake may prolong female reproductive function. We evaluated the association of long-term intake of vegetable protein, animal protein, and specific protein-rich foods with incidence of early natural menopause in the Nurses' Health Study II cohort. Women included in analyses (n = 85,682) were premenopausal at baseline (1991) and followed until 2011 for onset of natural menopause. Protein intake was assessed via food frequency questionnaire. In Cox proportional hazard models that were adjusted for age, smoking, body mass index, and other factors, women in the highest quintile of cumulatively averaged vegetable protein intake (median, 6.5% of calories) had a significant 16% lower risk of early menopause compared with women in the lowest quintile (3.9% of calories; 95% confidence interval: 0.73, 0.98; P for trend = 0.02). Intake of specific foods, including pasta, dark bread, and cold cereal, was also associated with lower risk (P
Soy: a complete source of protein. [2018]Soybeans contain all of the essential amino acids necessary for human nutrition and have been grown and harvested for thousands of years. Populations with diets high in soy protein and low in animal protein have lower risks of prostate and breast cancers than other populations. Increasing dietary whole soy protein lowers levels of total cholesterol, low-density lipoproteins, and triglycerides; may improve menopausal hot flashes; and may help maintain bone density and decrease fractures in postmenopausal women. There are not enough data to make recommendations concerning soy intake in women with a history of breast cancer. The refined soy isoflavone components, when given as supplements, have not yielded the same results as increasing dietary whole soy protein. Overall, soy is well tolerated, and because it is a complete source of protein shown to lower cholesterol, it is recommended as a dietary substitution for higher-fat animal products.
Animal Protein Intake Is Inversely Associated With Mortality in Older Adults: The InCHIANTI Study. [2022]In general, plant protein intake was inversely associated with mortality in studies in middle-aged adults. Our aim was to evaluate the long-term associations of animal and plant protein intake with mortality in older adults.
Impact of Dietary Protein on Osteoporosis Development. [2023]Osteoporosis is a frequent yet unsolved health problem among older people. The influence of dietary protein still raises many questions regarding its quality and quantity in the context of bone health. The aim of this manuscript is to review the latest evidence on plant and animal protein influences on bone health in various groups of patients. The review is based on original studies, meta-analyses, randomized controlled trials, and prospective cohort studies published in PubMed and Cochrane databases during the last five years. Combining plant and animal protein with physical activity has the best effect on bones (muscle strengthening and reducing the risk of falls), while high protein intake can have adverse effects during bed rest. Despite the content of isoflavones, plant protein is not more beneficial than animal protein (dairy products) and can increase bone resorption markers. Hypoestrogenism due to menopause or eating disorders leads to low bone density and an increased risk of osteoporosis. A well-balanced diet with sufficient energy supply and protein intake (both of plant and animal origins) and adequate physical activity are crucial to ensure bone health. Dietary interventions should consider the quantity and quality of protein in patients with other comorbidities, particularly in an aging society.
Soy isoflavones: are they useful in menopause? [2023]In October 1999, the US Food and Drug Administration authorized the use on food labels of health claims associated with soy protein and the reduced risk of coronary heart disease. Several studies have indicated that a total daily intake of 25 g of soy protein paired with a low-fat diet resulted in clinically important reductions of total cholesterol and low-density lipoprotein (LDL) cholesterol levels. Soybeans are a rich source of isoflavones, a class of phytoestrogens found predominantly in legumes and beans. Soy isoflavones are heterocyclic phenols with structural similarity to estradiol-17beta and selective estrogen receptor modulators. Actions at the cellular level depend on the target tissue, receptor status of the tissue, and the level of endogenous estrogen. Studies of soy-based diets evaluating the relation between soy consumption and serum lipid concentrations revealed that soy consumption significantly decreased total cholesterol, LDL cholesterol, and triglyceride levels. However, the soy isoflavones do not increase high-density lipoprotein cholesterol or triglyceride levels. The effects of soy protein on other target tissues reflect estrogenlike agonist and antagonist effects. Epidemiological studies suggest a protective effect of soy protein on breast tissue as evidenced by the lower rates of breast cancer in East Asian countries where soy is a predominant part of the diet. Data available from human studies on the effect of isoflavones on osteoporosis are limited, and additional studies are needed to support a role in osteoporosis prevention. Thus far, there is no evidence for a stimulatory effect of isoflavones on the endometrium. A few studies reveal a minimal effect of soy on hot flashes, with soy reducing hot flashes 45% and placebo causing a 30% reduction compared with an approximate 70% reduction in hot flashes with estrogen replacement therapy. Evidence from laboratory studies reveals neither a positive nor a negative effect of soy isoflavones on cognition. To date, no adverse effects of short- or long-term use of soy proteins are known in humans. The only adverse effects known are those reported in animals (infertility in sheep and quails grazing on phytoestrogen-rich pastures). In conclusion, soy isoflavones are biologically active compounds. Current data are insufficient to draw definitive conclusions regarding the use of isoflavones as an alternative to estrogen for hormone replacement in postmenopausal women. Although epidemiological and basic laboratory studies allude to the possible protective effects of soy isoflavones at specific target tissues, randomized, placebo-controlled clinical trials are necessary to address these important issues.
An examination of contributions of animal- and plant-based dietary patterns on the nutrient quality of diets of adult Canadians. [2022]Dietary guidance and Canada's 2019 Food Guide encourage increased consumption of plant-based foods as a source of dietary protein. However, there is an absence of recent data on protein and nutrient intakes and quality of Canadian dietary patterns that might occur with increased plant protein intakes. This study compared food sources and nutrient intakes of Canadian adults within groups of increasing plant protein-containing diets. The CCHS 2015 Public-Use Microdata File of single 24-hour dietary recalls of males and females ≥19 years (n = 6498) or ≥70 years (n = 1482) were examined. Respondents were allocated into 4 groups defined by their protein intake percentage coming from plant-based foods (i.e., group 1: 0-24.9%, group 2: 25-49.9%, group 3: 50-74.9%, group 4: 75-100%). Protein intake in adults averaged 63.3% animal and 36.7% plant protein. Where plant protein contributed >50% protein, higher intakes of carbohydrate, dietary fibre, folate, dietary folate equivalents, iron and magnesium (p < 0.001) but lower intakes of total and saturated fat, protein, vitamin D, vitamin B12, riboflavin and niacin (p < 0.0001) were reported. In contrast, group 1 had higher total and saturated fat, protein, vitamin B12, thiamin, niacin, and zinc, but lower carbohydrate, dietary fibre, and magnesium. Balancing plant- with animal-based protein foods leads to healthier dietary patterns with more favourable nutritional properties when compared with diets based on either high animal or high plant protein content. Novelty: Combinations of animal- and plant-based proteins improve nutrient quality of Canadian diets. The source of protein influences diet quality.
Effects of Soy Foods in Postmenopausal Women: A Focus on Osteosarcopenia and Obesity. [2020]Chronic diseases in postmenopausal women are caused by rapid changes in hormones and are accompanied by rapid changes in body composition (muscle, bone, and fat). In an aging society, the health of postmenopausal women is a social issue, and people's interest in ingesting high-quality protein is increasing in order to maintain a healthy body composition. This review aims to summarize the efficacy of soy foods and their impact on body composition. The soy protein and isoflavones contained in soy foods can improve muscle and bone density quality and reduce body weight. It is considered a breakthrough in preventing osteosarcopenia and obesity that may occur after menopause.
Sources and Amounts of Animal, Dairy, and Plant Protein Intake of US Adults in 2007-2010. [2018]Dietary guidelines suggest consuming a mixed-protein diet, consisting of high-quality animal, dairy, and plant-based foods. However, current data on the distribution and the food sources of protein intake in a free-living, representative sample of US adults are not available. Data from the National Health and Nutrition Examination Survey (NHANES), 2007-2010, were used in these analyses (n = 10,977, age ≥ 19 years). Several US Department of Agriculture (USDA) databases were used to partition the composition of foods consumed into animal, dairy, or plant components. Mean ± SE animal, dairy, and plant protein intakes were determined and deciles of usual intakes were estimated. The percentages of total protein intake derived from animal, dairy, and plant protein were 46%, 16%, and 30%, respectively; 8% of intake could not be classified. Chicken and beef were the primary food sources of animal protein intake. Cheese, reduced-fat milk, and ice cream/dairy desserts were primary sources of dairy protein intake. Yeast breads, rolls/buns, and nuts/seeds were primary sources of plant protein intake. This study provides baseline data for assessing the effectiveness of public health interventions designed to alter the composition of protein foods consumed by the American public.
Biological effects of isoflavones in young women: importance of the chemical composition of soyabean products. [2023]To examine the hormonal effects of isoflavones, of which soyabean is a rich source, fifteen healthy nonvegetarian premenopausal women were studied over 9 months. They lived in a metabolic suite for between 4 and 6 months where their diet and activity levels were kept constant and their hormonal status was measured over two or three menstrual cycles. During one (control) menstrual cycle a normal but constant diet containing no soyabean products was fed. Then, over a second complete cycle six subjects consumed a similar diet into which 60 g textured vegetable protein (TVP)/d, containing 45 mg conjugated isoflavones, had been incorporated. Three participants had 50 g miso (a fermented soyabean paste), containing 25 mg unconjugated isoflavones, added daily to their diet over a menstrual cycle, and six others consumed 28 g TVP/d, containing 23 mg conjugated isoflavones. Five participants completed a third diet period where they were randomly assigned to consume either the control diet over a cycle, or a similar diet incorporating 60 g of a soyabean product which had had the isoflavones chemically extracted (Arcon F). Follicular phase length was significantly (P
One year soy protein supplementation has positive effects on bone formation markers but not bone density in postmenopausal women. [2022]Although soy protein and its isoflavones have been reported to reduce the risk of osteoporosis in peri- and post-menopausal women, most of these studies are of short duration (i.e. six months). The objective of this study was to examine if one year consumption of soy-containing foods (providing 25 g protein and 60 mg isoflavones) exerts beneficial effects on bone in postmenopausal women.