InflammationNCT05245357
Impact of Foods on Bile Acids, Metabolites, and Inflammation
A study testing Lentil in people with Inflammation and Hypertriglyceridemia, run by Montana State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Hypertriglyceridemia, Metabolic Disease
- What is being tested?
- Lentil
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years of age
- Body Mass Index greater than 27 kg/m^2
Who cannot join
- taking medication that will influence cholesterol, lipids, or inflammation
- a gallbladder condition or have had the gallbladder removed
- allergy to wheat, dairy, or legumes
- pregnant or lactating
- have been on a ketogenic or paleo diet in the past 6 weeks
- have been on antibiotics in the past 90 days
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Nutrition Research Laboratory
Bozeman, Montana, 59717
Mary P Miles, PhD, 406-994-6678, mmiles@montana.edu
Stephanie M Wilson, MS, 406-994-5001, stephanie.keene@montana.edu
About this study
Official title: Therapeutic Impacts of Dietary Pulses on Bile Acids
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:
- determine the impact of acute lentil ingestion on serum postprandial bile acid responses and composition in a human cohort with obesity, and
- determine the impact of daily lentil consumption for 12 weeks on serum fasting and postprandial bile acid concentrations and composition in an overweight or obese cohort with elevated postprandial triglycerides.
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.
Read the detailed description
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.
- Conditions
- Inflammation, Hypertriglyceridemia, Metabolic Disease, Lipid Metabolism Disorder, Hyperlipidemias, Bile Acid Malabsorption
- Being tested
- Lentil, Control
- Medical subject headings
- Inflammation, Hypertriglyceridemia, Metabolic Diseases, Lipid Metabolism Disorders, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LentilBehavioural
Participants in the lentil arm of the study will consume a meal containing 140 g of lentils for breakfast one morning.
ControlBehavioural
Participants in the control arm of the study will consume a meal containing 0 g of lentils for breakfast one morning.
| Study group | Role | What they receive |
|---|---|---|
| Lentil, then Control | Experimental | 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. Receives: Behavioral: Lentil; Behavioral: Control |
| Control, then Lentil | Experimental | 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. Receives: Behavioral: Lentil; Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Bile Acid Response to High-Fat Meal
Area under the curve for bile acid concentration after consuming a meal containing 40g fat
Measured: 1 day
Peak Bile Acid Response to High-Fat Meal
Greatest change in bile acid concentration after consuming a meal containing 40g fat
Measured: 1 day
Postprandial Triglyceride Response to High-Fat Meal
Area under the curve for triglcyerides concentration after consuming a meal containing 40g fat
Measured: 1 day
Peak Triglyceride Response to High-Fat Meal
Greatest change in triglycerides concentration after consuming a meal containing 40g fat
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day
Gut Microbiome Composition
Relative abundance of operational taxonomic units of microbes measured from fecal samples
Measured: 1 day
Secondary outcomes (6)
Body Composition
% body fat
Measured: 1 day
Visceral Adipose Tissue
Quantity of adipose in liters located within the abdominal compartment
Measured: 1 day
Body Mass Index
kg of body mass per meter of height squared
Measured: 1 day
Habitual Diet
Habitual dietary intake from past month reported through a food frequency questionnaire for food, beverage, and supplement intake
Measured: 1 month
Acute Diet
Dietary intake from the last 24-hours, self-reported through a guided online prompt
Measured: 1 day
Acute Physical Activity
Physical activities from the last 24-hours, self-reported through a guided online promoted
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start24 Feb 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The design is 2 x 2 crossover design, where the overweight and obese adults without Type 2 Diabetes will be randomized into Control or Lentil
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary P Miles, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245357
- Sponsor's protocol ID
- AFRI Grant 2021-67028-34103
- Status last verified
- May 2023
- First submitted
- 31 Jan 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Impacts of Dietary Pulses on Bile Acids
- ClinicalTrials.gov ID
- NCT05245357
- Acronym / sponsor ID
- AFRI Grant 2021-67028-34103
- Conditions
- Inflammation, Hypertriglyceridemia, Metabolic Disease, Lipid Metabolism Disorder, Hyperlipidemias, Bile Acid Malabsorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- determine the impact of acute lentil ingestion on serum postprandial bile acid responses and composition in a human cohort with obesity, and
- determine the impact of daily lentil consumption for 12 weeks on serum fasting and postprandial bile acid concentrations and composition in an overweight or obese cohort with elevated postprandial triglycerides.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The design is 2 x 2 crossover design, where the overweight and obese adults without Type 2 Diabetes will be randomized into Control or Lentil
| Arm | Type | Receives |
|---|---|---|
| Lentil, then Control | Experimental | Behavioral: Lentil, Behavioral: ControlParticipants 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. |
| Control, then Lentil | Experimental | Behavioral: Lentil, Behavioral: ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 - 65 years of age
- Body Mass Index greater than 27 kg/m^2
Key exclusion criteria (6 listed)
- taking medication that will influence cholesterol, lipids, or inflammation
- a gallbladder condition or have had the gallbladder removed
- allergy to wheat, dairy, or legumes
- pregnant or lactating
- have been on a ketogenic or paleo diet in the past 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LentilParticipants in the lentil arm of the study will consume a meal containing 140 g of lentils for breakfast one morning. | Behavioural | Control, then Lentil, Lentil, then Control |
| ControlParticipants in the control arm of the study will consume a meal containing 0 g of lentils for breakfast one morning. | Behavioural | Control, then Lentil, Lentil, then Control |
Primary outcome
Postprandial Bile Acid Response to High-Fat Meal
Time frame: 1 day
Area under the curve for bile acid concentration after consuming a meal containing 40g fat
Peak Bile Acid Response to High-Fat Meal
Time frame: 1 day
Greatest change in bile acid concentration after consuming a meal containing 40g fat
Postprandial Triglyceride Response to High-Fat Meal
Time frame: 1 day
Area under the curve for triglcyerides concentration after consuming a meal containing 40g fat
Peak Triglyceride Response to High-Fat Meal
Time frame: 1 day
Greatest change in triglycerides concentration after consuming a meal containing 40g fat
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
Time frame: 1 day
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
Postprandial Serum Metabolite Response (untargeted) to a High-Fat Meal
Time frame: 1 day
Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis after consuming a meal containing 40g of fat
Fasting Serum Metabolite Response (untargeted) to a High-Fat Meal
Time frame: 1 day
Changes in concentrations of metabolites measured with untargeted liquid chromatography mass spectrometry (LCMS) metabolomic analysis before consuming a meal containing 40g of fat
Gut Microbiome Composition
Time frame: 1 day
Relative abundance of operational taxonomic units of microbes measured from fecal samples
6 secondary outcomes
Body Composition
Time frame: 1 day
Visceral Adipose Tissue
Time frame: 1 day
Body Mass Index
Time frame: 1 day
Habitual Diet
Time frame: 1 month
Acute Diet
Time frame: 1 day
Acute Physical Activity
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Miles, PhD principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lentil in people with Inflammation and Hypertriglyceridemia, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary P Miles, PhD (406-994-6678, mmiles@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Bile Acid Response to High-Fat Meal (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.