- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448067
Dietary Incorporation of Lentils to Improve Metabolic Health
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Montana
-
Bozeman, Montana, United States, 59717
- Montana State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI = or > than 27 kg/m^2
- Waist circumference > 35 inches for women and > 40 inches for men
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LOW Lentil Intake
Consumption of meals containing 60 g of lentils 5 out of 7 days per week for 8 weeks.
|
Dietary intake of moderate or high dose of lentils at midday meals
|
Experimental: HIGH Lentil Intake
Consumption of meals containing 120 g of lentils 5 out of 7 days per week for 8 weeks
|
Dietary intake of moderate or high dose of lentils at midday meals
|
Sham Comparator: CONTROL
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
|
Dietary intake of meals without lentils and matched to dietary lentil meals for total energy and protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Tolerance
Time Frame: Week 8
|
Blood glucose area under the curve during 2-h 75 g oral glucose tolerance (units = mmol/2 h)
|
Week 8
|
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)
|
Week 8
|
Visceral Adipose Tissue
Time Frame: Week 8
|
Volume of adipose tissue within the abdominal compartment (units = liters)
|
Week 8
|
Body Mass
Time Frame: Week 8
|
Total body mass (units = kg)
|
Week 8
|
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.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
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.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
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.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
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.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
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.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
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)
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
|
Serum Metabolome
Time Frame: Week 8
|
Serum metabolites (untargeted) measured from fasting serum (units can be either mmol or area under the curve)
|
Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting lipid panel
Time Frame: Week 8
|
Fasting serum concentrations of triglycerides, total cholesterol, and high-density lipoprotein (units = mmol)
|
Week 8
|
Fasting glucose
Time Frame: Week 8
|
Fasting serum concentration of glucose (units = mmol)
|
Week 8
|
C-reactive protein
Time Frame: Week 8
|
Fasting serum concentration of C-reactive protein (units = mg/l)
|
Week 8
|
Inflammatory cytokines
Time Frame: Week 8
|
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)
|
Week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity during the 8-week Intervention
Time Frame: Week 1, Week 8
|
Self-report of days per week that aerobic, strength, or stretching exercise are performed (unit = days/week)
|
Week 1, Week 8
|
Diet
Time Frame: Day 0
|
Habitual dietary intake reported through a food frequency questionnaire
|
Day 0
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USA DPLC MILES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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