Clinical TrialID 81

Dietary Incorporation of Lentils to Improve Metabolic Health

NCT04448067

Waist, Hypertriglyceridemic

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Record Fields

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Clinical Trial Id
81
Evidence Id
81
Core Evidence Id
81
Source Clinical Trial Id
75
Herb2 Clinical Trial Id
HBCT000075
Nct Id
NCT04448067
Title
Dietary Incorporation of Lentils to Improve Metabolic Health
Status
Completed
Phase
Study Result
No
Study Condition
Waist, Hypertriglyceridemic
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Intervention
BEHAVIORAL: Dietary Lentil Intake|BEHAVIORAL: No Dietary Lentil CONTROL
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Intervention Purpose
Prevention
Gender
All
Age
Adult, Older_Adult
Enrollment
35
Outcome Measure
Glucose Tolerance, 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, Serum insulin area under the curve during 2-h 75 g oral glucose tolerance test (units = pmol/2 h), Week 8|Visceral Adipose Tissue, Volume of adipose tissue within the abdominal compartment (units = liters), Week 8|Body Mass, Total body mass (units = kg), 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., 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., 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., 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., 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., 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), 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), Week 8
Sponsor Collaborator
Montana State University
Funded By
OTHER
Location
Montana State University, Bozeman, Montana, 59717, United States
Other Id
USA DPLC MILES
Start Date
2019-01-19
Primary Completion Date
2019-12-13
Completion Date
2019-12-13
First Posted
2020-06-25
Results First Posted
Last Update Posted
2020-06-25
Study Document
Study Url
https://clinicaltrials.gov/study/NCT04448067
Title Cn
Title En
Dietary Incorporation of Lentils to Improve Metabolic Health
Bilingual Status
semi_complete