Animal vs. Plant Proteins for Diabetes
(HP Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byBettina Mittendorfer
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Missouri-Columbia
Must not be taking: Dietary supplements
Disqualifiers: Prediabetes, Diabetes, Kidney disease, Vegetarians, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this proposal is to determine the effect of a high protein diet in which the increase in protein intake is derived from different sources (animal vs plant and protein-rich whole foods vs protein isolates) on: i) liver and muscle insulin sensitivity; ii) the metabolic response to a meal, and iii) 24-h plasma concentration profiles of glucose, glucoregulatory hormones, and protein-derived metabolites purported to cause metabolic dysfunction.
Will I have to stop taking my current medications?
The trial requires that you do not take medications known to affect the study outcomes. If you are on such medications, you may need to stop them to participate.
What data supports the effectiveness of the treatment 'Animal vs. Plant Proteins for Diabetes'?
Research shows that replacing animal protein with plant protein can modestly improve blood sugar control in people with diabetes. Plant-based diets, which include whole grains, nuts, and soy, may also help manage diabetes and reduce the risk of kidney problems.
12345Is it safe to consume high animal or plant protein diets for diabetes?
Research suggests that replacing animal protein with plant protein may improve blood sugar control in people with diabetes and could reduce the risk of developing type 2 diabetes. However, care should be taken to ensure nutritional balance, especially with plant proteins, as they may have lower bioavailability (how well nutrients are absorbed) compared to animal proteins.
56789How does the treatment of replacing animal protein with plant protein differ from other diabetes treatments?
This treatment is unique because it focuses on replacing animal protein with plant protein in the diet, which has shown modest improvements in blood sugar control for people with diabetes. Unlike traditional diabetes treatments that often involve medication, this approach emphasizes dietary changes to manage the condition.
2561011Eligibility Criteria
This trial is for adults aged 21-70 with a BMI between 24.5 and 32.5, who consume low protein diets and exercise minimally. Participants should be weight stable without significant organ dysfunction, chronic kidney disease, or metabolic conditions like diabetes. They must not have allergies to the study foods, take certain supplements or medications affecting the outcomes, be vegetarians/vegans, use tobacco excessively or drink alcohol.Inclusion Criteria
BMI: >24.5 and <32.5 kg/m2;
habitual protein intake <0.9 g/kg/day (assessed on 2 weekdays and 2 weekend days by using the HealthWatch 360 app); and
I am between 21 and 70 years old.
+1 more
Exclusion Criteria
I have prediabetes or type 2 diabetes.
You drink more alcohol than recommended (more than 14 drinks per week for women or more than 21 drinks per week for men) or use tobacco products.
I do not have major organ system diseases like cirrhosis.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dietary Intervention
Participants follow a high protein diet with protein intake from different sources (animal vs plant and protein-rich whole foods vs protein isolates) to assess effects on insulin sensitivity and metabolic response.
8-12 weeks
Follow-up
Participants are monitored for safety and effectiveness after dietary intervention
4 weeks
Participant Groups
The study examines how high-protein diets from different sources (animal vs plant-based; whole foods vs isolates) affect insulin sensitivity in liver and muscle, response to meals, and daily levels of glucose and hormones related to metabolism. It aims to understand if these proteins can influence metabolic health differently.
5Treatment groups
Experimental Treatment
Active Control
Group I: High plant protein whole foodExperimental Treatment1 Intervention
Group II: High plant protein isolateExperimental Treatment1 Intervention
Group III: High animal protein whole foodExperimental Treatment1 Intervention
Group IV: High animal protein isolateExperimental Treatment1 Intervention
Group V: Standard protein (control)Active Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Missouri School of MedicineColumbia, MO
Washington University in St. LouisSaint Louis, MO
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Who Is Running the Clinical Trial?
University of Missouri-ColumbiaLead Sponsor
Washington University School of MedicineLead Sponsor
References
Protein, diabetes, and nephropathy. [2017]Evidence suggests that a low-protein diet (0.8 g/kg) is beneficial in persons with diabetes with the onset of macroalbuminuria. Despite problems with existing studies, preliminary evidence suggests that vegetable proteins are not detrimental to renal function and may be used to supplement or replace animal proteins.
Predominantly vegetarian diet in patients with incipient and early clinical diabetic nephropathy: effects on albumin excretion rate and nutritional status. [2022]Several studies have suggested that dietary protein quality may be an important determinant in the natural history of renal disease. We have therefore studied the effects of a predominantly vegetarian diet in eight patients with Type 1 diabetes mellitus and an albumin excretion rate (AER) in excess of 30 micrograms min-1. The AER was measured after an 8-week run-in period on the patient's usual diet, and again after 8 weeks of a predominantly vegetarian diet in which the proportion of vegetable protein was supplemented in order to minimize the reduction in total dietary protein intake. The median fractional albumin clearance fell during the study from an initial value of 188 x 10(-+) (range 58-810 x 10(-4)) at the end of the run-in period to 87 x 10(-4) (23-829 x 10(-4)) at the end of the period on low animal protein diet (difference 79 x 10(-4) (95% Cl 9-149 x 10(-4)), p less than 0.05). The AER then returned to values similar to those obtained at the beginning of the study after a further 8 weeks in those patients returning to their usual diet. No significant changes in blood glucose control or in arterial pressure were observed. A predominantly vegetarian diet may therefore have important beneficial effects on diabetic nephropathy without the need for a heavily restricted total protein intake.
Renal, metabolic, and hormonal responses to proteins of different origin in normotensive, nonproteinuric type I diabetic patients. [2019]Whether the differences in renal function found in vegetarian compared with omnivorous subjects are related to quantity or quality of the protein is unknown. We have studied the renal function of nine normotensive, nonproteinuric type I diabetic patients who were fed in random order for 4 weeks either an animal protein diet (APD) (protein intake 1.1 g . kg-1 . day-1) or a vegetable protein diet VPD (protein intake 0.95 g . kg-1 . day-1). The two diets were isocaloric.
Type 2 diabetes and the vegetarian diet. [2018]Based on what is known of the components of plant-based diets and their effects from cohort studies, there is reason to believe that vegetarian diets would have advantages in the treatment of type 2 diabetes. At present there are few data on vegetarian diets in diabetes that do not in addition have weight loss or exercise components. Nevertheless, the use of whole-grain or traditionally processed cereals and legumes has been associated with improved glycemic control in both diabetic and insulin-resistant individuals. Long-term cohort studies have indicated that whole-grain consumption reduces the risk of both type 2 diabetes and cardiovascular disease. In addition, nuts (eg, almonds), viscous fibers (eg, fibers from oats and barley), soy proteins, and plant sterols, which may be part of the vegetarian diet, reduce serum lipids. In combination, these plant food components may have a very significant impact on cardiovascular disease, one of the major complications of diabetes. Furthermore, substituting soy or other vegetable proteins for animal protein may also decrease renal hyperfiltration, proteinuria, and renal acid load and in the long term reduce the risk of developing renal disease in type 2 diabetes. The vegetarian diet, therefore, contains a portfolio of natural products and food forms of benefit for both the carbohydrate and lipid abnormalities in diabetes. It is anticipated that their combined use in vegetarian diets will produce very significant metabolic advantages for the prevention and treatment of diabetes and its complications.
Effect of Replacing Animal Protein with Plant Protein on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]Previous research on the effect of replacing sources of animal protein with plant protein on glycemic control has been inconsistent. We therefore conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the effect of this replacement on glycemic control in individuals with diabetes. We searched MEDLINE, EMBASE, and Cochrane databases through 26 August 2015. We included RCTs ≥ 3-weeks comparing the effect of replacing animal with plant protein on HbA1c, fasting glucose (FG), and fasting insulin (FI). Two independent reviewers extracted relevant data, assessed study quality and risk of bias. Data were pooled by the generic inverse variance method and expressed as mean differences (MD) with 95% confidence intervals (CIs). Heterogeneity was assessed (Cochran Q-statistic) and quantified (I²-statistic). Thirteen RCTs (n = 280) met the eligibility criteria. Diets emphasizing a replacement of animal with plant protein at a median level of ~35% of total protein per day significantly lowered HbA1c (MD = -0.15%; 95%-CI: -0.26, -0.05%), FG (MD = -0.53 mmol/L; 95%-CI: -0.92, -0.13 mmol/L) and FI (MD = -10.09 pmol/L; 95%-CI: -17.31, -2.86 pmol/L) compared with control arms. Overall, the results indicate that replacing sources of animal with plant protein leads to modest improvements in glycemic control in individuals with diabetes. Owing to uncertainties in our analyses there is a need for larger, longer, higher quality trials.
Protein should be added to dietary advice on diabetes. [2019]Diets high in animal protein are associated with an increased risk of developing diabetes. There may also be an association for total protein rather than only animal sources. Consumption of energy from protein at the expense of carbohydrate or fat may similarly increase diabetes risk.
Protein content and amino acid composition in the diet of Danish vegans: a cross-sectional study. [2023]A growing proportion of the population are replacing their dietary animal protein with plant protein. A particular example of this trend is the vegan diet, which excludes all food items of animal origin. However, the DIAAS score for individual plant proteins is generally lower than that of animal proteins due to an unbalanced amino acid composition and lower bioavailability. Care must therefore be taken to meet the nutritional recommendations in the daily food intake.
Quality and Quantity of Protein Intake Influence Incidence of Type 2 Diabetes Mellitus in Coronary Heart Disease Patients: From the CORDIOPREV Study. [2021]Evidence suggests that enriching a diet with plant-based proteins could reduce the risk of developing type 2 diabetes mellitus. In the present work, we evaluated the association between the change in plant protein intake (adjusted by energy) and incidence of type 2 diabetes mellitus in patients with coronary heart disease from the CORDIOPREV (coronary diet intervention with olive oil and cardiovascular prevention) study. At baseline and during the follow-up, patients underwent medical examination and blood and oral glucose tolerance tests. Information on patient's dietary intake was gathered by registered dietitians using a validated food frequency questionnaire. A total of 106 out of 436 nondiabetic patients at baseline developed type 2 diabetes mellitus after a median follow-up of 60 months. Cox regression analyses showed that patients who belonged to the group that increased plant protein intake exhibited a lower risk of developing the disease (HR = 0.64, (0.43-0.96)). Changes in plant protein intake were positively correlated with changes in carbohydrates, fibre, and legumes intake and negatively correlated with changes in saturated fatty acids intake. Results of the present study support the need of improving diet with plant-based proteins to prevent the onset of type 2 diabetes mellitus.
Animal versus plant-based protein and risk of cardiovascular disease and type 2 diabetes: a systematic review of randomized controlled trials and prospective cohort studies. [2023]To systematically review the evidence on the effect of replacing the intake of animal protein with plant protein on cardiovascular disease (CVD) and type 2 diabetes (T2D) and their intermediate risk factors.
Beneficial effect of vegetable protein diet supplemented with psyllium plantago in patients with hepatic encephalopathy and diabetes mellitus. [2019]A controlled crossover study was performed in 8 diabetic patients with chronic portal-systemic encephalopathy. After a basal period the patients were treated during periods A and B. During period A, a meat protein diet (0.8 g/kg body wt, approximately 1800 kcal/day) was consumed and neomycin plus laxatives were given. During period B patients received vegetable protein (0.8 g/kg body wt, 1800 kcal/day). This diet was supplemented with psyllium fiber to reach 35 g of fiber per day. Four patients were randomly assigned to receive the treatments in the order A-B and the other 4 patients in the order B-A. At the end of the first experimental period, fasting glucose levels were 204 +/- 86 mg% in the meat protein diet group and 127 +/- 8 mg% in the vegetable protein diet group (p less than 0.014). The patients were receiving 2.5 +/- 0.2 g/day and 2.1 +/- 0.5 g/day of tolbutamide at the end of the meat protein diet and vegetable protein diet, respectively. In all cases, fasting glucose levels decreased at the end of the vegetable diet period regardless of the previous treatment. An improvement of greater than or equal to 25 mg% of fasting glucose levels was observed in 7 of the 8 patients after the vegetable protein diet and in no case after the meat protein diet (p less than 0.0078). The parameters of encephalopathy were comparable at the end of both the meat protein diet and the vegetable protein diet. A significant increase in the number of bowel movements was noticed after the vegetable diet plus fiber (p less than 0.01). We propose the use of vegetable diet plus fiber to facilitate the treatment of patients with both diabetes and hepatic encephalopathy.
Protein and vegetarian diets. [2020]A vegetarian diet can easily meet human dietary protein requirements as long as energy needs are met and a variety of foods are eaten. Vegetarians should obtain protein from a variety of plant sources, including legumes, soy products, grains, nuts and seeds. Eggs and dairy products also provide protein for those following a lacto-ovo-vegetarian diet. There is no need to consciously combine different plant proteins at each meal as long as a variety of foods are eaten from day to day, because the human body maintains a pool of amino acids which can be used to complement dietary protein. The consumption of plant proteins rather than animal proteins by vegetarians may contribute to their reduced risk of chronic diseases such as diabetes and heart disease.