Waist, HypertriglyceridemicNCT04448067
Dietary Incorporation of Lentils to Improve Metabolic Health
A study testing Dietary Lentil Intake in people with Waist, Hypertriglyceridemic, run by Montana State University at 1 site in United States.
Trial summary
Approximately 40% of Americans are pre-diabetic or diabetic, mostly in the form of type 2 diabetes (T2D), which is heavily influenced by diet. Three interrelated factors driving the progression of T2D are large glycemic and lipidemic responses after a meal, consumption of excess calories, and increased fat within the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Waist, Hypertriglyceridemic
- What is being tested?
- Dietary Lentil Intake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2019to 13 Dec 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI = or > than 27 kg/m^2
- Waist circumference > 35 inches for women and > 40 inches for men
Who cannot join
- Allergy to wheat
- Taking medication that will influence glucose, cholesterol, lipids, or inflammation
- Pregnant
- Diabetes
- Having a pacemaker
- Other health conditions that may interfere with study outcomes
- Planning a weight loss or change in exercise regimen
Trial locations and contacts
1 site in 1 country.
About this study
Approximately 40% of Americans are pre-diabetic or diabetic, mostly in the form of type 2 diabetes (T2D), which is heavily influenced by diet. Three interrelated factors driving the progression of T2D are large glycemic and lipidemic responses after a meal, consumption of excess calories, and increased fat within the abdominal compartment, referred to as visceral adipose tissue (VAT). Available research suggests that these problems may be attenuated with pulse consumption both at the time of consumption and at the next meal, in what is referred to as the second meal effect. Associations between pulse consumption and metabolic health have been measured in observational studies; unfortunately, randomized clinical trials data to establish cause and effect in humans are typically short in duration (≤ 4 weeks), limited to a single dose of pulse consumption (none exclusively for lentils), and not designed to strategically exploit the well-established second meal effect. We expect the impact of lentil intake will be greatest if consumed at the midday meal to offset the magnitude of the response to the large caloric intake typical in the evening. Our overarching hypothesis is that midday lentil consumption in individuals at greater risk for metabolically driven diseases will improve metabolic health. The purpose of this proposal is to determine whether eight weeks of 0, 300, or 600 grams per week of lentils by individuals with elevated VAT will improve insulin sensitivity, hepatic insulin resistance, lipid profiles (total cholesterol, triglycerides, LDL and HDL lipoproteins), inflammation, appetite and satiety, body mass, body composition, and volume of VAT.
Read the detailed description
Investigators utilized a parallel intervention of two separate dietary lentil doses versus control (no lentils) treatments for eight weeks in adults with elevated waist circumference. Enrolled participants were randomized to LOW (300 g lentils/week), HIGH (600 g lentils/week), or CONTROL (0 g lentils/week) treatment groups using block randomization. Outcome variables were assessed before and after 8 weeks of the dietary intervention.
Procedures:
Anthropometrics. Measurements were collected from participants before and after the intervention using the validated segmental multifrequency bioelectrical impedance analysis (SECA mBCA515, Hamburg, Germany) (cite). Fat mass (%) and estimated visceral adipose (L) were used for analysis.
Glycemic Challenge. An oral glucose tolerance test (OGTT) was administered as a meal which contained white bread containing 75 g or available carbohydrate. Water was provided with the meal. Caffeinated black tea was provided for participants who identified as habitual morning caffeine consumers. Participants were instructed to avoid alcohol consumption and strenuous physical activity in the 24 hours before their visit and to complete an overnight fast (10 -12 hours) before blood collection. Fasting blood samples were collected by venipuncture by a trained phlebotomist before ingestion of the glycemic challenge meal. A fingerstick was used to obtain blood for glucose and insulin prior to ingestion of bread and every 30 minutes in the 2-hour postprandial period.
Dietary Intervention: Experimental diets were provided to participants in the form of five pre-made midday meals containing 0, 60, or 120 g per meal matched across treatment groups for total energy and protein. Midday meals were targeted in this study to exploit the second meal effect of lower caloric intake at the next meal, the evening meal. Participants were instructed to consume all of the meal provided to them at the midday meal and then proactively reduce portion sizes and not eat beyond fullness at the evening meal. Participants were instructed to eat the meals Monday through Friday, and to eat any missed meals on Saturday or Sunday. Compliance was checked with random emails once per week and verbal reporting when picking up weekly meals.
Assessment of Satisfaction with Meal Provided: An email or text message questionnaire was sent to each participant for them to complete in real time at 4:00 pm one evening per week. Day of the week was varied so that each of the five weekdays was sampled at least once. Participants were asked to rate the following question "How much do you like your meal provided today?" on a scale from 1 (dislike extremely) to 9 (like extremely).
Assessment of Satiety: An email or text message questionnaire was sent to each participant for them to complete in real time at 4:00 pm one evening per week. Day of the week was varied so that each of the five weekdays was sampled at least once. To assess the elements of satiety, participants rated each of the following questions on a scale of 0 to 10: How hungry are you? (0 = not at all, 10 = extremely); How full are you? (0 = not at all, 10 = extremely); How satisfied do you feel? (0 = not at all, 10 = extremely); How strong is your desire to eat? (0 = very weak, 10 = very strong); How much do you think you could (or would want to) eat right now? (0 = nothing, 10 = very large amount)
Assessment of Gastrointestinal Comfort: An email or text message questionnaire was sent to each participant for them to complete in real time at 8:00 pm one evening per week. Day of the week was varied so that each of the five weekdays was sampled at least once. To assess gastrointestinal comfort, participants rated the following symptoms as none, mild, moderate, or severe: flatulence, bloating, cramping, abdominal discomfort.
Blood analysis: Whole blood in serum separating tubes was allowed to clot for 15 minutes before centrifugation at 1200 RPM for 15 minutes with resulting serum aliquoted and stored at -80ºC until analysis.Determination of blood markers. Blood markers of metabolic syndrome as defined by the World Health Organization were determined from whole blood run on Picollo Xpress Chemistry Analyzer lipid panels (Abaxis, Union City, USA). Glycated hemoglobin (HbA1c) was determined using the DCA Vantage Analyzer (Siemens Medical Solutions Diagnostics, Cergy-Pontoise, France) performed according to manufacturer instructions. Insulin concentrations from fasting and postprandial samples were determined through a high-sensitivity insulin ELISA kit according to manufacturer instructions (ALPCO, Salem, NH, United States). Fasting insulin and glucose concentrations were used to calculate homeostasis model assessment of insulin resistance (HOMA-IR). The Matsuda Index was calculated from fasting and postprandial glucose and insulin concentrations. The postprandial glucose and insulin concentrations in response to the OGTT were input into the incremental area under the curved (AUC) method.
- Conditions
- Waist, Hypertriglyceridemic
- Being tested
- Dietary Lentil Intake, No Dietary Lentil CONTROL
- Keywords
- glycemic control, inflammation, triglyceride, satiety, gastrointestinal comfort, pulse crop, lentil
- Medical subject headings
- Hypertriglyceridemic Waist, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Lentil IntakeBehavioural
Dietary intake of moderate or high dose of lentils at midday meals
No Dietary Lentil CONTROLBehavioural
Dietary intake of meals without lentils and matched to dietary lentil meals for total energy and protein
| Study group | Role | What they receive |
|---|---|---|
| LOW Lentil Intake | Experimental | Consumption of meals containing 60 g of lentils 5 out of 7 days per week for 8 weeks. Receives: Behavioral: Dietary Lentil Intake |
| HIGH Lentil Intake | Experimental | Consumption of meals containing 120 g of lentils 5 out of 7 days per week for 8 weeks Receives: Behavioral: Dietary Lentil Intake |
| CONTROL | Sham comparator | Consumption of meals matched in total energy and protein to the lentil meals but containing 0 g of lentils 5 out 7 days per week for 8 weeks Receives: Behavioral: No Dietary Lentil CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance
Blood glucose area under the curve during 2-h 75 g oral glucose tolerance (units = mmol/2 h)
Measured: Week 8
Insulin Response During Glucose Tolerance Test
Serum insulin area under the curve during 2-h 75 g oral glucose tolerance test (units = pmol/2 h)
Measured: Week 8
Visceral Adipose Tissue
Volume of adipose tissue within the abdominal compartment (units = liters)
Measured: Week 8
Body Mass
Total body mass (units = kg)
Measured: Week 8
Hunger during the 8-week Intervention
Subjective rating at 4:00 pm in response to the question: "How hungry are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Lower rating of hunger is a better outcome.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Fullness during the 8-week Intervention
Subjective rating at 4:00 pm in response to the question: "How full are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Higher rating of fullness is a better outcome.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Satiety during the 8-week Intervention
Subjective rating at 4:00 pm in response to the question: "How satisfied do you feel?"(Ordinal scale ratings from 0 = not at all, 10 = extremely). Higher rating of satiety is a better outcome.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Desire to Eat during the 8-week Intervention
Subjective rating at 4:00 pm in response to the question: "How strong is your desire to eat?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of desire to eat is a better outcome.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Appetite during the 8-week Intervention
Subjective rating at 4:00 pm in response to the question: "How much do you think you could (or would want to) eat right now?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of appetite is a better outcome.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Gastrointestinal Comfort during the 8-week Intervention
Subjective ratings of level of flatulance, bloating, cramping, and abdominal discomfort participants experienced after eating study meals. (Ratings = none, mild, moderate, severe)
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Serum Metabolome
Serum metabolites (untargeted) measured from fasting serum (units can be either mmol or area under the curve)
Measured: Week 8
Secondary outcomes (4)
Fasting lipid panel
Fasting serum concentrations of triglycerides, total cholesterol, and high-density lipoprotein (units = mmol)
Measured: Week 8
Fasting glucose
Fasting serum concentration of glucose (units = mmol)
Measured: Week 8
C-reactive protein
Fasting serum concentration of C-reactive protein (units = mg/l)
Measured: Week 8
Inflammatory cytokines
Fasting serum concentrations of tumor necrosis factor-alpha, interleukin (IL)-1beta, IL-6, IL-10, IL-17, IL-23, interferon gamma, and granulocyte-macrophage colony stimulating factor. (units = pg/ml)
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start19 Jan 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waist, HypertriglyceridemicStudies 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
- Parallel groups
- Model description
- This study utilized a parallel intervention of meals with 0, 60 or 120 g of lentils 5 days per week for 8 in overweight or obese adults with elevated waist circumference.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
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
- NCT04448067
- Sponsor's protocol ID
- USA DPLC MILES
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 25 Jun 2020
- 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 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Incorporation of Lentils to Improve Metabolic Health
- ClinicalTrials.gov ID
- NCT04448067
- Acronym / sponsor ID
- USA DPLC MILES
- Conditions
- Waist, Hypertriglyceridemic
- Keywords
- glycemic control, inflammation, triglyceride, satiety, gastrointestinal comfort, pulse crop, lentil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 25 Jun 2020 (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.
Approximately 40% of Americans are pre-diabetic or diabetic, mostly in the form of type 2 diabetes (T2D), which is heavily influenced by diet. Three interrelated factors driving the progression of T2D are large glycemic and lipidemic responses after a meal, consumption of excess calories, and increased fat within the abdominal compartment, referred to as visceral adipose tissue (VAT). Available research suggests that these problems may be attenuated with pulse consumption both at the time of consumption and at the next meal, in what is referred to as the second meal effect. Associations between pulse consumption and metabolic health have been measured in observational studies; unfortunately, randomized clinical trials data to establish cause and effect in humans are typically short in duration (≤ 4 weeks), limited to a single dose of pulse consumption (none exclusively for lentils), and not designed to strategically exploit the well-established second meal effect. We expect the impact of lentil intake will be greatest if consumed at the midday meal to offset the magnitude of the response to the large caloric intake typical in the evening. Our overarching hypothesis is that midday lentil consumption in individuals at greater risk for metabolically driven diseases will improve metabolic health. The purpose of this proposal is to determine whether eight weeks of 0, 300, or 600 grams per week of lentils by individuals with elevated VAT will improve insulin sensitivity, hepatic insulin resistance, lipid profiles (total cholesterol, triglycerides, LDL and HDL lipoproteins), inflammation, appetite and satiety, body mass, body composition, and volume of VAT.
Detailed description
Investigators utilized a parallel intervention of two separate dietary lentil doses versus control (no lentils) treatments for eight weeks in adults with elevated waist circumference. Enrolled participants were randomized to LOW (300 g lentils/week), HIGH (600 g lentils/week), or CONTROL (0 g lentils/week) treatment groups using block randomization. Outcome variables were assessed before and after 8 weeks of the dietary intervention.
Procedures:
Anthropometrics. Measurements were collected from participants before and after the intervention using the validated segmental multifrequency bioelectrical impedance analysis (SECA mBCA515, Hamburg, Germany) (cite). Fat mass (%) and estimated visceral adipose (L) were used for analysis.
Glycemic Challenge. An oral glucose tolerance test (OGTT) was administered as a meal which contained white bread containing 75 g or available carbohydrate. Water was provided with the meal. Caffeinated black tea was provided for participants who identified as habitual morning caffeine consumers. Participants were instructed to avoid alcohol consumption and strenuous physical activity in the 24 hours before their visit and to complete an overnight fast (10 -12 hours) before blood collection. Fasting blood samples were collected by venipuncture by a trained phlebotomist before ingestion of the glycemic challenge meal. A fingerstick was used to obtain blood for glucose and insulin prior to ingestion of bread and every 30 minutes in the 2-hour postprandial period.
Dietary Intervention: Experimental diets were provided to participants in the form of five pre-made midday meals containing 0, 60, or 120 g per meal matched across treatment groups for total energy and protein. Midday meals were targeted in this study to exploit the second meal effect of lower caloric intake at the next meal, the evening meal. Participants were instructed to consume all of the meal provided to them at the midday meal and then proactively reduce portion sizes and not eat beyond fullness at the evening meal. Participants were instructed to eat the meals Monday through Friday, and to eat any missed meals on Saturday or Sunday. Compliance was checked with random emails once per week and verbal reporting when picking up weekly meals.
Assessment of Satisfaction with Meal Provided: An email or text message questionnaire was sent to each participant for them to complete in real time at 4:00 pm one evening per week. Day of the week was varied so that each of the five weekdays was sampled at least once. Participants were asked to rate the following question "How much do you like your meal provided today?" on a scale from 1 (dislike extremely) to 9 (like extremely).
Assessment of Satiety: An email or text message questionnaire was sent to each participant for them to complete in real time at 4:00 pm one evening per week. Day of the week was varied so that each of the five weekdays was sampled at least once. To assess the elements of satiety, participants rated each of the following questions on a scale of 0 to 10: How hungry are you? (0 = not at all, 10 = extremely); How full are you? (0 = not at all, 10 = extremely); How satisfied do you feel? (0 = not at all, 10 = extremely); How strong is your desire to eat? (0 = very weak, 10 = very strong); How much do you think you could (or would want to) eat right now? (0 = nothing, 10 = very large amount)
Assessment of Gastrointestinal Comfort: An email or text message questionnaire was sent to each participant for them to complete in real time at 8:00 pm one evening per week. Day of the week was varied so that each of the five weekdays was sampled at least once. To assess gastrointestinal comfort, participants rated the following symptoms as none, mild, moderate, or severe: flatulence, bloating, cramping, abdominal discomfort.
Blood analysis: Whole blood in serum separating tubes was allowed to clot for 15 minutes before centrifugation at 1200 RPM for 15 minutes with resulting serum aliquoted and stored at -80ºC until analysis.Determination of blood markers. Blood markers of metabolic syndrome as defined by the World Health Organization were determined from whole blood run on Picollo Xpress Chemistry Analyzer lipid panels (Abaxis, Union City, USA). Glycated hemoglobin (HbA1c) was determined using the DCA Vantage Analyzer (Siemens Medical Solutions Diagnostics, Cergy-Pontoise, France) performed according to manufacturer instructions. Insulin concentrations from fasting and postprandial samples were determined through a high-sensitivity insulin ELISA kit according to manufacturer instructions (ALPCO, Salem, NH, United States). Fasting insulin and glucose concentrations were used to calculate homeostasis model assessment of insulin resistance (HOMA-IR). The Matsuda Index was calculated from fasting and postprandial glucose and insulin concentrations. The postprandial glucose and insulin concentrations in response to the OGTT were input into the incremental area under the curved (AUC) method.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study utilized a parallel intervention of meals with 0, 60 or 120 g of lentils 5 days per week for 8 in overweight or obese adults with elevated waist circumference.
| Arm | Type | Receives |
|---|---|---|
| LOW Lentil Intake | Experimental | Behavioral: Dietary Lentil IntakeConsumption of meals containing 60 g of lentils 5 out of 7 days per week for 8 weeks. |
| HIGH Lentil Intake | Experimental | Behavioral: Dietary Lentil IntakeConsumption of meals containing 120 g of lentils 5 out of 7 days per week for 8 weeks |
| CONTROL | Sham comparator | Behavioral: No Dietary Lentil CONTROLConsumption of meals matched in total energy and protein to the lentil meals but containing 0 g of lentils 5 out 7 days per week for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI = or > than 27 kg/m^2
- Waist circumference > 35 inches for women and > 40 inches for men
Key exclusion criteria (7 listed)
- Allergy to wheat
- Taking medication that will influence glucose, cholesterol, lipids, or inflammation
- Pregnant
- Diabetes
- Having a pacemaker
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 |
|---|---|---|
| Dietary Lentil IntakeDietary intake of moderate or high dose of lentils at midday meals | Behavioural | HIGH Lentil Intake, LOW Lentil Intake |
| No Dietary Lentil CONTROLDietary intake of meals without lentils and matched to dietary lentil meals for total energy and protein | Behavioural | CONTROL |
Primary outcome
Glucose Tolerance
Time frame: Week 8
Blood glucose area under the curve during 2-h 75 g oral glucose tolerance (units = mmol/2 h)
Insulin Response During Glucose Tolerance Test
Time frame: Week 8
Serum insulin area under the curve during 2-h 75 g oral glucose tolerance test (units = pmol/2 h)
Visceral Adipose Tissue
Time frame: Week 8
Volume of adipose tissue within the abdominal compartment (units = liters)
Body Mass
Time frame: Week 8
Total body mass (units = kg)
Hunger during the 8-week Intervention
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How hungry are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Lower rating of hunger is a better outcome.
Fullness during the 8-week Intervention
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How full are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Higher rating of fullness is a better outcome.
Satiety during the 8-week Intervention
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How satisfied do you feel?"(Ordinal scale ratings from 0 = not at all, 10 = extremely). Higher rating of satiety is a better outcome.
Desire to Eat during the 8-week Intervention
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How strong is your desire to eat?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of desire to eat is a better outcome.
Appetite during the 8-week Intervention
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How much do you think you could (or would want to) eat right now?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of appetite is a better outcome.
Gastrointestinal Comfort during the 8-week Intervention
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective ratings of level of flatulance, bloating, cramping, and abdominal discomfort participants experienced after eating study meals. (Ratings = none, mild, moderate, severe)
Serum Metabolome
Time frame: Week 8
Serum metabolites (untargeted) measured from fasting serum (units can be either mmol or area under the curve)
4 secondary outcomes
Fasting lipid panel
Time frame: Week 8
Fasting glucose
Time frame: Week 8
C-reactive protein
Time frame: Week 8
Inflammatory cytokines
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No
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 Dietary Lentil Intake in people with Waist, Hypertriglyceridemic, 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 7 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: finished, as of the sponsor's last update on 25 Jun 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Tolerance (time frame: Week 8). The study lists 11 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 25 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.