An interventional study of Lentil and Control in Inflammation, Hypertriglyceridemia and Metabolic Disease, sponsored by Montana State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Montana State University · Not applicable, Interventional, and Prevention
Among 150 studies in Hypertriglyceridemia with a site in United States — 10 open to participants now, 16 under way, 4 of them phase 3. Hypertriglyceridemia · United States.
Among the 150 studies in Hypertriglyceridemia with a site in United States, this one is the 109th largest by planned enrollment of the 145 interventional ones that give a count, is one of 6 that started in 2022, is one of 36 with no phase, reaches primary completion later than 0 of the 15 other live ones, and was the 127th registered.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
Browse Hypertriglyceridemia studies →10 of the 150 studies in Hypertriglyceridemia with a site in United States are open now. Recruiting first, the newest first:
Ionis Pharmaceuticals, Inc. · Sites in United States, Canada
Eli Lilly and Company · Sites in United States, Canada, China and 1 more country
Marea Therapeutics · Sites in United States
The Miriam Hospital · Sites in United States
Marea Therapeutics · Sites in United States, Australia, Canada and 1 more country
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 22 Hypertriglyceridemia studies recruiting now, 9 (41%) set no upper age limit and 12 (55%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
150 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 51 · Phase 3 30 · Phase 4 13
First in 1977; this study’s year is marked. 6 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Median enrollment 52 across the 145 interventional studies, 130 across the 3 observational. Of the 124 that completed or were terminated, 57 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
74 of 150 have an industry lead sponsor. The 10 most frequent:
Montana State University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Montana State University has 4 studies filed under Hypertriglyceridemia — fewer than ten, so there is no comparison to draw.
9 of the studies in Hypertriglyceridemia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05681351Phase 3Ionis Pharmaceuticals, Inc.CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) | 2027-03 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT05464784MediciNovaMN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia | 2026-12-31 |
| NCT07269210Eli Lilly and CompanyA Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia | 2027-03 |
| NCT07491172CRISPR Therapeutics AGA Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias | 2027-06 |
Among the 150 studies in Hypertriglyceridemia with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Dietary incorporation of pulse crops may be an effective way to lower unhealthy elevations in serum bile acids. These elevations play a direct role in promoting obesity-related diseases estimated to be present in about one third of the US adult population, including non-alcoholic fatty liver disease and type 2 diabetes. The overarching hypothesis for this study is that pulse consumption increases bile acid secretion and excretion, which will decrease toxicity linked to excess accumulation of bile in the liver, improve metabolism, and lower resulting levels of bile acids in the serum. In direct alignment with the USDA-AFRI Food, Safety, Nutrition, and Health priority to address obesity and related chronic disease with increased fruit and vegetable consumption and also with the American Pulse Association call to investigate the impact of regular pulse consumption on human physical well- being, the long-term research goal of this study is to establish effective and practical therapeutic strategies utilizing dietary incorporation of pulse crops to prevent or reverse obesity driven diseases. The specific objectives in this proposal are to:
This proposal is being submitted in response to the American Pulse Association commodity board sponsored topic of investigating the impact pulse crop consumption on health.
The approach for Objective 1 is to enroll a population of overweight/obese individuals (n=24) in a two-armed (LENTIL and CONTROL), randomized, crossover trial in which each individual participant serves as his/her own control to compare postprandial serum bile acid responses between isocaloric meals with the same amount of fat with (LENTIL) and without (CONTROL) lentils. Isocaloric meals with the same total fat content in LENTIL and CONTROL study arms will provide the same stimulus to induce increased postprandial serum bile acids. The randomized crossover design with half of the participants starting in the LENTIL arm and the other half starting in the CONTROL arm will eliminate potential order effects. Block randomization with 3 blocks of two equally numbered levels (total of 8 per block) will be created. Having each person serve as their own control in a crossover trial will eliminate the influence of inter-individual variation. The MSU Nutrition Research team has extensive experience with postprandial testing protocols and dietary manipulation and will utilize this experience to perform the proposed protocol with appropriate pre-test standardization, uniformity of meal preparation, precise timing of blood collection, and established procedures for processing and analyzing blood samples. Bile acids, including all primary and secondary forms, will be analyzed from samples collected before the meal and at 30-minute intervals for 4 hours after the meal. Established methods in the MSU Proteomics, Metabolomics, and Mass Spectrometry Facility will be used to compare total and individual bile acids between LENTIL and CONTROL conditions.
The approach for Objective 2 will leverage banked samples from a highly synergistic ongoing clinical trial comparing 12 weeks of daily lentil consumption to control. This study utilizes a randomized, parallel research design to compare the impact of ingesting 140 g of lentils per day to 0 g per day for 12 weeks on serum triglyceride and inflammation responses to a high-fat meal. High fat meals induce the largest serum bile acid responses so the current proposal augments this study by adding assessment of the impact of prolonged lentil consumption on the appearance of bile acids in the systemic circulation under fasting and postprandial conditions. In contrast to Objective 1, which focuses on the acute impact of incorporating lentils into a meal, Objective 2 will measure the impact of adaptations to lentil ingestion that improve enterohepatic function. These changes may be facilitated by changes to the composition of the gut microbiome, enhanced bile acid excretion, or other mechanisms independent of having lentils in the challenge meal. Data from the ongoing trial will be analyzed to determine whether lentils induced changes in the composition of the gut microbiome. This proposal will analyze whether lentil consumption increases excretion of bile acids by analyzing bile acid composition of stool samples collected before and after lentil supplementation. In sum, adding analysis of serum and stool bile acids from samples collected and banked in an ongoing clinical trial, will allow the determination of whether lentil consumption over time improves enterohepatic health in a way that reduces appearance of bile acids in serum and or increases excretion of bile acids.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 24 is below the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Montana State University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Compared within Hypertriglyceridemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants first received a meal with 140 g of lentils in the morning. After a washout period of at least 7 days, they then received a meal with 0 g of lentils in the morning.
Behavioral: Lentil · Behavioral: Control
Participants first received a meal with 0 g of lentils in the morning. After a washout period of at least 7 days, they then received a meal with 140 g of lentils in the morning.
Behavioral: Lentil · Behavioral: Control
Participants in the lentil arm of the study will consume a meal containing 140 g of lentils for breakfast one morning.
Participants in the control arm of the study will consume a meal containing 0 g of lentils for breakfast one morning.
Postprandial Bile Acid Response to High-Fat Meal
Area under the curve for bile acid concentration after consuming a meal containing 40g fat
Time frame: 1 day
Peak Bile Acid Response to High-Fat Meal
Greatest change in bile acid concentration after consuming a meal containing 40g fat
Time frame: 1 day
Postprandial Triglyceride Response to High-Fat Meal
Area under the curve for triglcyerides concentration after consuming a meal containing 40g fat
Time frame: 1 day
Peak Triglyceride Response to High-Fat Meal
Greatest change in triglycerides concentration after consuming a meal containing 40g fat
Time frame: 1 day
Postprandial Serum Inflammatory Cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) Response to High-fat Meal
Area under the curve for inflammatory cytokine (tumor necrosis factor-alpha, interleukin-(IL)1beta, IL-6, IL-10, IL-17, IL-23, interferon-gamma, and granulocyte macrophage-colony stimulating factor; all in pg/ml) concentrations after consuming a meal containing 40 g of fat
Time frame: 1 day
Postprandial Serum Metabolite Response (untargeted) to a High-Fat Meal
Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis after consuming a meal containing 40g of fat
Time frame: 1 day
Fasting Serum Metabolite Response (untargeted) to a High-Fat Meal
Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis before consuming a meal containing 40g of fat
Time frame: 1 day
Gut Microbiome Composition
Relative abundance of operational taxonomic units of microbes measured from fecal samples
Time frame: 1 day
Body Composition
% body fat
Time frame: 1 day
Visceral Adipose Tissue
Quantity of adipose in liters located within the abdominal compartment
Time frame: 1 day
Body Mass Index
kg of body mass per meter of height squared
Time frame: 1 day
Habitual Diet
Habitual dietary intake from past month reported through a food frequency questionnaire for food, beverage, and supplement intake
Time frame: 1 month
Acute Diet
Dietary intake from the last 24-hours, self-reported through a guided online prompt
Time frame: 1 day
Acute Physical Activity
Physical activities from the last 24-hours, self-reported through a guided online promoted
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for May 2024, 27 months after the start.
Of 42 non-industry interventional studies with no phase under Hypertriglyceridemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 27 months is above that.
Counting every sponsor, half of 45 studies reached it within 23 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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Montana State University