Monounsaturated Fatty Acid Supplementation for Prediabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Brigham and Women's Hospital
Trial Summary
What is the purpose of this trial?This trial is testing a supplement called Palmitoleic acid on overweight and obese adults with pre-diabetes. The supplement aims to improve how the body handles sugar and reduce liver fat. It works by helping the liver, muscles, and fat tissue function better.
Do I have to stop taking my current medications for the trial?
Yes, you must stop taking most medications, except for thyroid hormone (if TSH is normal), anti-hypertensives (if blood pressure is <150/90), and non-steroidal rescue inhalers for asthma. You also cannot use over-the-counter supplements, except for vitamin D, and must avoid supplements like fish oil for 3 months before the study.
What data supports the idea that Monounsaturated Fatty Acid Supplementation for Prediabetes is an effective treatment?
The available research shows that Monounsaturated Fatty Acid Supplementation, specifically with palmitoleic acid, can help improve insulin sensitivity and reduce inflammation in a prediabetes model. This means it can help the body use insulin more effectively and lower inflammation, which are important for managing prediabetes. Compared to other treatments like omega-3 fatty acids, which are more focused on heart health and do not significantly affect glucose control, Monounsaturated Fatty Acid Supplementation seems to have a more direct impact on managing prediabetes.
12345What safety data exists for monounsaturated fatty acid supplementation in prediabetes?
The available research indicates that palmitoleic acid (POA), a monounsaturated fatty acid, has been studied for its effects on glucose and lipid metabolism, insulin sensitivity, and inflammation in prediabetic models. While the specific safety data is not detailed in the provided abstracts, POA is generally reported as beneficial in terms of insulin sensitivity and glucose tolerance in both human and animal studies. However, one study mentioning POA was withdrawn, which may suggest some concerns or issues that were not specified. Overall, the studies suggest potential therapeutic benefits, but specific safety data is not explicitly provided in the abstracts.
16789Is Palmitoleic acid a promising treatment for prediabetes?
Palmitoleic acid, a type of monounsaturated fatty acid, shows promise as a treatment for prediabetes. It can help regulate blood sugar levels, improve how the body uses insulin, and reduce inflammation, which are all important for managing prediabetes.
1281011Eligibility Criteria
Adults aged 18-70 with a BMI of 25-40, prediabetes (HbA1c between 5.6 - 6.5), and no major chronic diseases can join this trial. They should not be pregnant, breastfeeding, or have recently lost significant weight. Participants must not be on certain medications or have had more than three servings/day of high-fat dairy for the last three months.Participant Groups
The study is testing if Palmitoleic acid (POA), an omega-7 fat found in diet, can improve insulin sensitivity and reduce liver fat in overweight individuals with prediabetes. This double-blind placebo-controlled trial compares POA against a placebo to see which is more effective.
2Treatment groups
Active Control
Placebo Group
Group I: Palmitoleic acidActive Control1 Intervention
The treatment arm will receive Palmitoleic acid (POA) supplement as Provinal® 420 mg capsules with at least 90% pure POA Ethyl Ester (less than 1% palmitic acid). Participants will be asked to consume 2 Provinal® 420 mg capsules twice a day for 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
The placebo is a medium chain fatty acid in triglyceride form. The placebo has no shown health effects, neither beneficial or detrimental. Participants will be asked to consume 2 placebo capsules daily twice a day for 8 weeks.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
Tersus Life Sciences LLCIndustry Sponsor
References
The Different Insulin-Sensitising and Anti-Inflammatory Effects of Palmitoleic Acid and Oleic Acid in a Prediabetes Model. [2022]Monounsaturated fatty acids (MUFA) are understood to have therapeutic and preventive effects on chronic complications associated with type 2 diabetes mellitus (T2DM); however, there are differences between individual MUFAs. Although the effects of palmitoleic acid (POA) are still debated, POA can regulate glucose homeostasis, lipid metabolism, and cytokine production, thus improving metabolic disorders. In this study, we investigated and compared the metabolic effects of POA and oleic acid (OA) supplementation on glucose and lipid metabolism, insulin sensitivity, and inflammation in a prediabetic model, the hereditary hypertriglyceridemic rat (HHTg). HHTg rats exhibiting genetically determined hypertriglyceridemia, insulin resistance, and impaired glucose tolerance were fed a standard diet. POA and OA were each administered intragastrically at a dose of 100 mg/kg b.wt. for four weeks.
Fat modification in the diabetes diet. [2015]The modification of dietary fat in the diet of diabetic patients is of interest with respect to metabolic and other consequences of this modification. To begin with the data are reviewed for the use of monounsaturated fatty acids (MUFA) in the diabetes diet. Compared to a carbohydrate-rich diet, glucose concentrations are lower. Blood pressure was also found to be lower. There were no major differences with respect to lipid concentrations. HDL-cholesterol levels tended to be higher after a MUFA-rich diet. In type-1 diabetic patients, the number of circulating big VLDL particles was greater after a MUFA diet than after a carbohydrate-rich diet. Comparisons were also made between diets enriched with MUFA and with polyunsaturated fatty acids (PUFA). With respect to lipid concentrations, different groups observed different effects. While one group saw no differences in fasting lipids, they measured a higher remnant-like particle cholesterol after a diet enriched with MUFA. Another group found higher total and LDL-cholesterol levels after a PUFA-rich diet than after a MUFA-diet. In their study, fasting glucose, insulin and fasting chylomicrons and postprandial chylomicrons and VLDL were higher following the PUFA diet. A MUFA-rich diet increased endothelium-dependent flow-mediated dilatation in the superficial femoral artery. Alpha-linolenic acid appears to be a precursor of eicospentaenoic and docosahexaenoic fatty acids. As a diet rich in n-6 PUFA reduces this conversion, a n-6/n-3 PUFA ratio not exceeding 4 - 6 should be observed. No prospective data are available for alpha-linolenic acid in diabetic patients. The review summarizes the results of the Lyon Diet Heart Study and the Nurses' Health Study. Both studies saw a reduced cardiovascular risk associated with a higher intake of alpha-linolenic acid. Finally, data on the effects of fish oil are given. The latter has a clearly expressed triglyceride-lowering effect. Data with respect to glucose control are heterogeneous. Major studies did not find any influence in glucose concentrations. Hepatic glucose production and peripheral insulin sensitivity remained constant. Evidently, nerve function can be improved by fish oil. Data have been compiled comparing the effects of fish oil with those of olive oil, linseed oil and sunflower oil.
n-3 long-chain polyunsaturated fatty acids in type 2 diabetes: a review. [2022]Historically, epidemiologic studies have reported a lower prevalence of impaired glucose tolerance and type 2 diabetes in populations consuming large amounts of the n-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFAs) found mainly in fish. Controlled clinical studies have shown that consumption of n-3 LC-PUFAs has cardioprotective effects in persons with type 2 diabetes without adverse effects on glucose control and insulin activity. Benefits include lower risk of primary cardiac arrest; reduced cardiovascular mortality, particularly sudden cardiac death; reduced triglyceride levels; increased high-density lipoprotein levels; improved endothelial function; reduced platelet aggregability; and lower blood pressure. These favorable effects outweigh the modest increase in low-density lipoprotein levels that may result from increased n-3 LC-PUFA intake. Preliminary evidence suggests increased consumption of n-3 LC-PUFAs with reduced intake of saturated fat may reduce the risk of conversion from impaired glucose tolerance to type 2 diabetes in overweight persons. Reported improvements in hemostasis, slower progression of artery narrowing, albuminuria, subclinical inflammation, oxidative stress, and obesity require additional confirmation. Expected health benefits and public health implications of consuming 1 to 2 g/day n-3 LC-PUFA as part of lifestyle modification in insulin resistance and type 2 diabetes are discussed.
Omega-3 and omega-6 fatty acids and type 2 diabetes. [2021]Polyunsaturated fatty acids are of particular interest in the nutritional therapy for diabetes, given their potential role in several pathophysiological processes related to cardiovascular disease. Both omega-3 and omega-6 fatty acids are beneficial for improving lipid profiles in healthy individuals and among type 2 diabetic patients: Supplementation with omega-3 fatty acids lowers triglycerides and VLDL-cholesterol. However, they might also increase LDL-cholesterol. Omega-3 fatty acids are, from the latest evidence, not related to mortality and cardiovascular disease. Similarly, glucose control and hypertension, as well as risk of microvascular complications, seem unaffected by omega-3 supplementation. Most studies involved mainly patients with type 2 diabetes, and future research needs to focus on the type 1 diabetic patient. Also, the role of omega-6 fatty acids remains largely unknown.
[Use of omega-3 in diabetic patients]. [2015]The use of omega-3 fatty acids for diabetic patients is based on well confirmed observations concerning the presence of cardiovascular risk factors in these patients. Changes of lipid metabolism, reduced erythrocyte deformability, increased platelet aggregation, and high blood pressure often found in subjects with diabetes mellitus are all favourably influenced by the administration of eicosapentanoic and docosahexanoic acid. In non insulin dependent subjects, these fatty acids may bring about a rapid reversible deterioration of blood glucose balance while in insulin dependent patients there is no relevant interference. Therefore, omega-3 administration would appear advisable in insulin dependent diabetics with increased cardiovascular risk factors.
Effects of dietary palmitoleic acid on vascular function in aorta of diabetic mice. [2022]Chronic hyperglycemia in diabetes causes atherosclerosis and progresses to diabetic macroangiopathy, and can lead to coronary heart disease, myocardial infarction and cerebrovascular disease. Palmitoleic acid (POA) is a product of endogenous lipogenesis and is present in fish and vegetable oil. In human and animal studies, POA is reported as a beneficial fatty acid related to insulin sensitivity and glucose tolerance. However, few studies have reported its effects on aortic function in diabetes. Here, we investigated the effects of POA administration on vascular function in KKAy mice, a model of type 2 diabetes.
WITHDRWAN: Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: a double-blinded, randomized, placebo controlled study. [2022]Purified palmitoleic acid (16-1; omega-7) has shown lipid-lowering and anti-inflammatory benefits in open label, epidemiologic, and animal studies.
Palmitic and Oleic Acid: The Yin and Yang of Fatty Acids in Type 2 Diabetes Mellitus. [2022]Increased plasma non-esterified fatty acids (NEFAs) link obesity with insulin resistance and type 2 diabetes mellitus (T2DM). However, in contrast to the saturated FA (SFA) palmitic acid, the monounsaturated FA (MUFA) oleic acid elicits beneficial effects on insulin sensitivity, and the dietary palmitic acid:oleic acid ratio impacts diabetes risk in humans. Here we review recent mechanistic insights into the beneficial effects of oleic acid compared with palmitic acid on insulin resistance and T2DM, including its anti-inflammatory actions, and its capacity to inhibit endoplasmic reticulum (ER) stress, prevent attenuation of the insulin signaling pathway, and improve β cell survival. Understanding the molecular mechanisms of the antidiabetic effects of oleic acid may contribute to understanding the benefits of this FA in the prevention or delay of T2DM.
Comparing the simultaneous determination of cis- and trans-palmitoleic acid in fish oil using HPLC and GC. [2020]Cis- and trans-palmitoleic acids (Cis-POA and trans-POA) are isomers of palmitoleic acid, a monounsaturated fatty acid which affects glucose and lipid metabolism, and reduces insulin resistance. Trans-POA is used as a biomarker for indicating the risk of type II diabetes and coronary heart disease, but no methods of analysis or distinguishing between cis-POA and trans-POA have yet been reported.
Dietary fatty acids in the management of diabetes mellitus. [2018]Dietary fatty acid recommendations for patients with diabetes mellitus may be neither similar to, nor extrapolated from, those for the normal population; some evidence suggests that diabetes prevalence may be correlated with the dietary ratio of n-6 to n-3 fatty acids. In human experiments, n-3 fatty acids may improve many of the metabolic sequelae of insulin resistance by lowering blood pressure and triacylglycerol concentrations. In animals, n-3 fatty acids may cause less weight gain than other fats; however, they may raise low-density-lipoprotein concentrations, increase hepatic glucose output, and decrease insulin secretion in non-insulin-dependent diabetes mellitus. In a minority of patients with insulin-dependent diabetes mellitus, glycemic control may be adversely affected n-6 Fatty acids lower plasma cholesterol but may increase lipoprotein oxidation. Glucose in the presence of transition metals may produce free radicals and result in pancreatic damage and the formation of glycosylation products that inhibit nitric oxide-mediated smooth muscle relaxation; fish oil may counter these effects. High-carbohydrate, low-fat diets, once recommended for diabetes mellitus, appear to aggravate hypertriglyceridemia and are inferior to diets high in monounsaturated fatty acids (MUFAs) if saturated fats are kept to a minimum. MUFA-rich diets improve lipid profiles and may also have antioxidant properties. However, high-fat diets-whatever their composition-promote obesity. Current advice individualizes carbohydrate and fat requirements to optimize blood glucose and lipid concentrations in a lifestyle program to control obesity, exercise, smoking, and blood pressure. Fatty acid modifications may fine-tune the diet if proper balance is kept between the different long-chain polyunsaturated fatty acids and antioxidant requirements.
Dietary fats and diabetes mellitus: is there a good fat? [2019]As knowledge of the fatty acid functions has increased, so has the complexity of making dietary fat recommendations to people with type 2 diabetes. Oleic acid seems to offer a slight advantage over linoleic acid in reducing plasma glucose, insulin levels, total cholesterol, low-density lipoproteins (LDLs), and triglycerides, but may also have atherogenic properties through another mechanism. A diet containing a higher proportion of polyunsaturated fatty acids (PUFAs) may require a concomitant increase in antioxidant intake because PUFAs oxidize easily and are then converted to oxidized LDL, which is more atherogenic. In addition to raising total and LDL cholesterol, long chain saturated free fatty acids may interact with plasma glucose to increase insulin secretion. Omega-3 fatty acids decrease triglycerides and reduce the risk of fatal cardiac arrhythmias. Glycemic control does not appear to be adversely affected by omega-3 fatty acids at amounts of up to 3 g/d.