[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07376226":3,"trial-entities:NCT07376226":153,"trial-summary:NCT07376226":157},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":39,"interventions":42,"primary_outcomes":47,"secondary_outcomes":76,"sex":92,"minimum_age":93,"maximum_age":94,"healthy_volunteers":15,"eligibility_criteria":95,"std_ages":119,"locations":122,"central_contacts":141,"overall_officials":144,"references":147,"see_also_links":152},"NCT07376226","25-1444","Effects of Whole Fruit on Blood Sugar in People With Type 2 Diabetes","Effects of Whole Fruit on Glycemic Control, Liver Fat, and Cardiovascular Disease Risk Factors in Adults With Type 2 Diabetes","NOT_YET_RECRUITING","2028-04","2026-07","2026-07-07","2026-09","Harvard School of Public Health (HSPH)","OTHER",false,"This study will determine the effects of consuming whole fruit on blood sugar control, liver fat, and cardiovascular health in adults with type 2 diabetes who are not treated with insulin.","Diabetes is one of the top three drivers of healthcare costs in the U.S., and nearly half of Americans will develop either diabetes or prediabetes in their lifetime. It is therefore critical to find new strategies to treat or reverse diabetes.\n\nOne such approach is adopting a healthy diet, which can dramatically improve blood sugar levels in adults with type 2 diabetes and even induce diabetes remission in some patients. Despite this, not much is known about which food groups are most effective at improving blood sugar levels in patients with diabetes.\n\nAlthough individuals with type 2 diabetes are often advised to reduce carbohydrate intake, current dietary guidelines also recommend consuming fruit and other carbohydrate-rich foods. This has led to confusion among patients and clinicians about whether eating fruit, particularly in larger amounts, is beneficial or harmful for blood sugar and overall health. Whole fruit differs from many other carbohydrate sources in that whole fruit is rich in fiber, vitamins, minerals, and bioactive plant compounds, while being relatively low in energy density.\n\nMost prior research examining the effects of whole fruit in people with type 2 diabetes has been epidemiologic, focused on individual fruits, or combined whole fruit with fruit juice and\u002For vegetables into a single food category. As a result, it is unknown how whole fruit, as a food category, affects glycemic control and cardiovascular health.\n\nThe investigators previously found that a whole-fruit-rich, Mediterranean-style diet improved blood sugar control and blood pressure in patients with type 2 diabetes and even allowed some patients to wean off all anti-hyperglycemic medications. The investigators will conduct a follow-up study to determine the effects of whole fruit alone on glycemic control, liver fat, and cardiovascular risk factors. The study will be a single-arm controlled feeding study to determine the effects of eating a large amount of whole fruit for 17 weeks on glycemic control (Aim 1), liver fat (Aim 2a), and cardiovascular disease risk factors (Aim 2b) in patients with insulin-independent type 2 diabetes. The primary measures of glycemic control will be mean 24-hour glucose levels (as measured by continuous glucose monitoring) and mean 3-hour glucose levels (as measured during a 3-hour oral glucose tolerance test). These assessments will be supplemented by, and interpreted in light of, other glycemic outcomes, which are listed as outcomes #3-9 below.\n\nBy providing controlled, high-quality evidence, this study will determine whether whole fruit is good or bad for patients with type 2 diabetes and will improve dietary guidelines for the hundreds of millions of individuals with type 2 diabetes.",[19],"Type 2 Diabetes",[21,22,23,24,25,26,27,28,29,30,31,32,33,34],"type 2 diabetes","whole fruit","dietary intervention","glycemic control","liver fat","continuous glucose monitoring","blood sugar","nutrition","fruit","glucose","insulin","blood pressure","carbohydrates","high-carbohydrate diet","INTERVENTIONAL","TREATMENT",[38],"NA",{"count":40,"type":41},25,"ESTIMATED",[43],{"type":14,"name":44,"description":45,"armGroupLabels":46},"Whole Fruit","Participants will consume a large amount of whole fruit for 17 weeks. During the first 6.5 weeks, participants will gradually increase the amount of whole fruit they eat by 5% every 5 days. Once they reach 50% of their calories as whole fruit, they will continue to eat 50% fruit for the remaining 10.5 weeks of the study. This is a controlled feeding study, so participants will consume fruit prepared in a metabolic kitchen. The fruit will consist of fresh fruit, dried fruit, and frozen fruit blended into smoothies. To demonstrate compliance, participants will video-record themselves eating the provided fruit. All participants will receive the same dietary intervention. Participants will otherwise continue their usual diet and lifestyle habits.",[44],[48,52,55,58,61,64,67,70,73],{"measure":49,"description":50,"timeFrame":51},"Mean 24-hour Glucose Levels","Average 24-hour interstitial glucose levels (mg\u002Fdl), as measured by continuous glucose monitoring (CGM). If needed, data will be adjusted for any changes in antihyperglycemic medication use, using the medication effect score (MES).","Change from baseline to week 17",{"measure":53,"description":54,"timeFrame":51},"Mean 3-hour Glucose Levels","Mean glucose (mg\u002Fdl) during a 3-hour oral glucose tolerance test (OGTT)",{"measure":56,"description":57,"timeFrame":51},"Mean 3-hour Insulin","Mean insulin (mU\u002Fl) during a 3-hour OGTT",{"measure":59,"description":60,"timeFrame":51},"Mean 3-hour C-Peptide","Mean C-Peptide (ng\u002Fml) during a 3-hour OGTT",{"measure":62,"description":63,"timeFrame":51},"Insulin Sensitivity","Insulin sensitivity (dl\u002Fkg\u002Fmin\u002FμU\u002Fml) during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model",{"measure":65,"description":66,"timeFrame":51},"Dynamic Beta-Cell Responsivity","Phi\\_dynamic during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi\\_dynamic is a measure of beta-cell responsiveness during first-phase insulin secretion. It is a dimensionless index (arbitrary units), where higher values denote greater insulin secretion",{"measure":68,"description":69,"timeFrame":51},"Static Beta-Cell Responsivity","Phi\\_static during a 3-hour OGTT, as measured by the Oral C-Peptide Minimal Model (which is a set of 5 coupled differential equations; see reference under Citations). Phi\\_static is a measure of beta-cell responsiveness during second-phase insulin secretion. The units of measure are min\\^-1, and higher values denote greater insulin secretion.",{"measure":71,"description":72,"timeFrame":51},"Glycemic Variability","Measures of glucose variability derived from continuous glucose monitoring, including mean amplitude of glycemic excursions and standard deviation (mg\u002Fdl).",{"measure":74,"description":75,"timeFrame":51},"Time-in-range Metrics from CGM","Standard time-in-range metrics, including time-below-range (TBR), time-in-range (TIR), and time-above-range (TAR), as standardized by the International Consensus on Time in Range. Values will be reported as percentages of the 24-hour day.",[77,80,83,86,89],{"measure":78,"description":79,"timeFrame":51},"Intrahepatic Lipid (Liver Fat)","Percentage as measured using Magnetic Resonance Spectroscopy (MRS) and 3-point M-Dixon Magnetic Resonance Imaging (MRI)",{"measure":81,"description":82,"timeFrame":51},"Body Weight","kg",{"measure":84,"description":85,"timeFrame":51},"Systolic and Diastolic Blood Pressure","mm Hg",{"measure":87,"description":88,"timeFrame":51},"Heart Rate","beats per minute",{"measure":90,"description":91,"timeFrame":51},"Lipids","Fasting total cholesterol (mg\u002Fdl), LDL cholesterol (mg\u002Fdl), HDL cholesterol (mg\u002Fdl), and triglycerides (mg\u002Fdl).","ALL","18 Years",null,{"inclusion":96,"exclusion":101,"raw_text":118},[97,98,99,100],"Aged ≥18 years","Diagnosed with type 2 diabetes","HbA1c between 6.5-12.0%","Fasting C-peptide level ≥0.5 ng\u002Fml, indicating the patient does not have beta-cell failure, as measured at screening",[102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117],"On insulin","Evidence of latent autoimmune diabetes (LADA) or maturity-onset diabetes of the young (MODY)","Estimated glomerular filtration rate (eGFR) \\\u003C45 ml\u002Fmin per 1.73 m²","Heart attack in the past 6 months or severe\u002Funstable heart failure","On weight loss medication, including GLP-1 receptor agonists (e.g., semaglutide, dulaglutide)","Change in the dosage of a chronic medication that may affect study endpoints within the past 3 months","Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)","Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones","Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise participant safety or data validity","Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years","Lost or gained more than 5 lbs (or more than 2% of body weight if the patient weighs \\>250 lbs) of weight in the past 2 months","Pregnant, planning to become pregnant in the next 6 months, or breastfeeding","Major psychiatric condition that would affect the ability to participate in the study","Not able to eat the provided study meals (e.g., food allergies)","Behavioral factors or circumstances that may impede adherence to the dietary intervention","Not able to undergo the MRI scan (e.g., due to claustrophobia, implanted metal objects, or body girth ≥60 cm)","Inclusion Criteria:\n\n* Aged ≥18 years\n* Diagnosed with type 2 diabetes\n* HbA1c between 6.5-12.0%\n* Fasting C-peptide level ≥0.5 ng\u002Fml, indicating the patient does not have beta-cell failure, as measured at screening\n\nExclusion Criteria:\n\n* On insulin\n* Evidence of latent autoimmune diabetes (LADA) or maturity-onset diabetes of the young (MODY)\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 ml\u002Fmin per 1.73 m²\n* Heart attack in the past 6 months or severe\u002Funstable heart failure\n* On weight loss medication, including GLP-1 receptor agonists (e.g., semaglutide, dulaglutide)\n* Change in the dosage of a chronic medication that may affect study endpoints within the past 3 months\n* Clinically significant laboratory abnormality (e.g., abnormal hemoglobin levels)\n* Significant gastrointestinal disease, major gastrointestinal surgery, or gallstones\n* Significant cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that might compromise participant safety or data validity\n* Evidence of cancer (other than non-melanoma skin cancer) within the last 5 years\n* Lost or gained more than 5 lbs (or more than 2% of body weight if the patient weighs \\>250 lbs) of weight in the past 2 months\n* Pregnant, planning to become pregnant in the next 6 months, or breastfeeding\n* Major psychiatric condition that would affect the ability to participate in the study\n* Not able to eat the provided study meals (e.g., food allergies)\n* Behavioral factors or circumstances that may impede adherence to the dietary intervention\n* Not able to undergo the MRI scan (e.g., due to claustrophobia, implanted metal objects, or body girth ≥60 cm)",[120,121],"ADULT","OLDER_ADULT",[123],{"facility":124,"city":125,"state":126,"zip":127,"country":128,"contacts":129,"geoPoint":138},"Harvard T. H. Chan School of Public Health","Boston","Massachusetts","02115","United States",[130,135],{"name":131,"role":132,"phone":133,"email":134},"Kathleen Johnson","CONTACT","617-998-6333","fruit2@hsph.harvard.edu",{"name":136,"role":137},"Courtney M Peterson, PhD","PRINCIPAL_INVESTIGATOR",{"lat":139,"lon":140},42.35843,-71.05977,[142],{"name":143,"role":132,"phone":133,"email":134},"Kathleen Johnson Research Project Manager, MPH, RD",[145],{"name":146,"affiliation":13,"role":137},"Courtney M Peterson",[148],{"pmid":149,"type":150,"citation":151},"24651807","BACKGROUND","Cobelli C, Dalla Man C, Toffolo G, Basu R, Vella A, Rizza R. The oral minimal model method. Diabetes. 2014 Apr;63(4):1203-13. doi: 10.2337\u002Fdb13-1198.",[],{"nct_id":4,"conditions":154,"biomarkers":156},[155],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":158,"summary":159,"prompt_version":169},true,{"design":160,"status":161,"heading":162,"summary":163,"follow_up":164,"word_count":165,"commitments":166,"compensation":167,"drugs_mentioned":168},"This is an interventional study with about 25 participants. It will test the effects of consuming whole fruit over 17 weeks.","completed","Whole Fruit and Blood Sugar in Type 2 Diabetes","This study is looking at how eating whole fruit affects blood sugar levels, liver fat, and heart health in adults with type 2 diabetes who are not taking insulin. Participants will gradually increase the amount of whole fruit they eat over 6.5 weeks until 50% of their daily calories come from whole fruit, and then continue this for the rest of the 17-week study. Researchers will measure your 24-hour and 3-hour blood sugar levels, as well as 3-hour insulin levels, to see the effects. You may be able to join if you are at least 18 years old, have type 2 diabetes with an HbA1c between 6.5-12.0%, and a fasting C-peptide level of 0.5 ng\u002Fml or higher. The study is currently recruiting about 25 participants.","Your blood sugar and insulin levels will be measured at the end of the 17-week study period.",125,"You would gradually increase your whole fruit intake over 6.5 weeks, then maintain a high whole fruit diet for the remaining study period. Blood sugar and insulin levels will be measured at the beginning and at week 17.","Not stated in the trial record.",[44],"v2"]