A Double Blind Study on the Gastrointestinal Effects of Arabinoxylan (Leaf Fiber Extract).
NCT ID: NCT04100460
Last Updated: 2019-09-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
45 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-30
Study Completion Date
2020-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The objective of this study is to investigate the effect on Arabinoxylan on gastrointestinal (GI) tolerance, bowel habits, and microbiota in adults. The study is a randomized, placebo-controlled, crossover, single-center trial with 3 study periods separated by minimum 2-week washout periods. 45 healthy adults will be recruited for the trial. Participants will be required to drink a beverage twice a day for 3 weeks during each study period. The beverage will contain either approximately 7.25 grams of Arabinoxylan leaf fiber extract per day, or approximately 14.5 grams of Arabinoxylan leaf fiber extract per day, or will not contain any Arabinoxylan (control). Subjects will record their bowel movements daily, fill out daily questionnaires about their gastrointestinal systems, and record their food intake at specified times during the study. Stool samples will also be collected prior to and at the end of each study period for analysis of bacteria composition.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Fibre Supplementation on Mixed-meal Challenge Response
NCT04829396
Health Status
COMPLETED
NA
Fiber Fermentation Study
NCT04570137
Intestinal Health
COMPLETED
NA
Fabulous Fibre Study - Effect of Wheat Bran Extract on Gut and General Health in Healthy Aging Subjects (FFS)
NCT02693782
Hypercholesterolemia
Flatulence
Intestinal Diseases
COMPLETED
NA
Dietary Fibers Effect on the Gut Microbiota Composition
NCT04114513
Microbiome
Metabolic Syndrome
Cardiovascular Risk Factor
+2 more
WITHDRAWN
NA
A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals
NCT06188949
Aging
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study is a randomized, placebo-controlled, crossover, single-center trial with one screening visit (Visit 1; Week -1) and 3 test periods \[Test Period 1 (Visits 2 and 3; Weeks 0 to 3), Test Period 2 (Visits 4 and 5; Weeks 5 to 8), and Test Period 3 (Visits 6 and 7; Weeks 10 to 13)\] separated by minimum 2-week washout periods.
At Visit 1 (Week -1), subjects will provide informed consent and undergo assessments of medical history and prior, current medication/supplement use, and inclusion and exclusion criteria and a last menses query, where applicable. Additionally, height, body weight, and vital signs will be measured and BMI will be calculated. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology, and female subjects will undergo an in-clinic urine pregnancy test. Subjects will be instructed to maintain physical activity and habitual diet as much as possible with the exception of excluding fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha). Subjects will be dispensed a Baseline Diet Diary with instructions to record intake 7 days prior to Visit 2 (Week 0). Subjects will also be dispensed a Bowel Habits Diary and Daily GI Tolerance Questionnaire with instructions to complete these during the 7 days prior to Visit 2 (Week 0). Finally, subjects will be dispensed a stool collection kit and will be instructed to collect one fecal sample from one bowel movement during the 3 days prior to Visit 2 (Week 0). Subjects will be reminded that they are not required to fast prior to Visit 2 (Week 0) and will be encouraged to eat breakfast prior to their visit.
At Visit 2 (Week 0), subjects will arrive at the clinic to undergo clinic visit procedures (concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight and vital signs measurements, last menses query, where applicable). Subjects will be queried about compliance with study instructions. The fecal sample will be collected and the Bowel Habits Diary, Baseline Diet Diary, and Daily GI Tolerance Questionnaire will be collected and reviewed. Subjects will be assigned to a randomization sequence. The first study product consumption will occur in the clinic and subject will be dispensed the remaining study products according to their assigned randomization sequence for home consumption (twice a day, once in the morning and once in the evening, with or without food). Subjects who consumed breakfast at home prior to arriving at the clinic will be administered the study product alone while those who did not consume breakfast prior to arriving at the clinic will be administered the study product with a snack. Subjects will also be dispensed a Study Product Diary to record study product intake. Subjects will be dispensed a copy of the last 5 days of their completed Baseline Diet Diary (reviewed at Visit 2, Week 0) and will be instructed to replicate the same food and beverage intake as closely as possible during the days prior to the collection of their fecal sample, which will occur during the 3 days immediately prior to Visit 3 (Week 3). Additionally, subjects will be dispensed 3-day Analysis Diet Records with instructions to record all food and beverages consumed during 3 days (2 weekdays and one weekend) following Visit 2 (Week 0) and before Visit 3 (Week 3) that do not coincide with the 5 replication days immediately prior to Visit 3 (Week 3). Subjects will be dispensed a Bowel Habits Diary and stool collection kit, and will be instructed to complete the Bowel Habits Diary during the 7 days immediately prior to Visit 3 (Week 3) and to collect a fecal sample from one bowel movement during the 3 days immediately prior to Visit 3 (Week 3). Subjects will also be dispensed a Daily GI Tolerance Questionnaire with instructions to complete the questionnaire daily starting from Visit 2 (Week 0) up to Visit 3 (Week 3). Finally, study instructions will also be provided \[(i.e., overnight fasting (12 ± 2 h, water only), maintenance of physical activity with the exception of avoiding vigorous physical activity for 24 h prior; maintenance of habitual diet as much as possible with the exception of avoiding alcohol for 24 h prior and excluding fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha) and consumption of study products\].
At Visit 3 (Week 3), subjects will arrive at the clinic to undergo clinic visit procedures (concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight, and vital signs measurements, last menses query, where applicable) and adverse event (AE) assessments. Subjects will be queried about compliance with study instructions and diet replication. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Fecal samples will be collected and the Bowel Habits Diary, Daily GI Tolerance Questionnaire, and the 3-day Analysis Diet Record will be collected and reviewed. The Study Product Diary will be collected/reviewed, any unused study products will be collected, and compliance with study product consumption will be assessed. The Product Likeability Questionnaire will be administered in clinic. Subjects will be dispensed a stool collection kit and will be instructed to collect a fecal sample from one bowel movement during the 3 days immediately prior to Visit 4 (Week 5). Subjects will also be dispensed a copy of the last 5 days of their completed Baseline Diet Diary (reviewed at Visit 2, Week 0) and will be instructed to replicate the same food and beverage intake as closely as possible during the days prior to the collection of their fecal sample, which will occur during the 3 days immediately prior to Visit 4 (Week 5). Subjects will also be instructed to begin the 2-week washout period and return to the clinic to begin Test Period 2 at Visit 4 (Week 5). Finally, study instructions will also be provided \[(i.e., maintenance of physical activity; maintenance of habitual diet as much as possible with the exception of excluding fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha)\]. Subjects will also be reminded that they are not required to fast prior to Visit 4 (Week 5) and will be encouraged to eat breakfast prior to their visit.
At Visit 4 (Week 5), subjects will return to the clinic, crossover to the other study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exception of the randomization procedure. At Visit 5 (Week 8), subjects will repeat the procedures from Visit 3 (Week 3), followed by a 2-week washout period before starting Test Period 3 at Visit 6 (Week 10). At Visit 6 (Week 10), subjects will return to the clinic, crossover to the other study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exception of the randomization procedure. Finally, at Visit 7 (Week 13), subjects will repeat the procedures from Visit 3 (Week 3).
At Visit 1 (Week -1), subjects will provide informed consent and undergo assessments of medical history and prior, current medication/supplement use, and inclusion and exclusion criteria and a last menses query, where applicable. Additionally, height, body weight, and vital signs will be measured and BMI will be calculated. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology, and female subjects will undergo an in-clinic urine pregnancy test. Subjects will be instructed to maintain physical activity and habitual diet as much as possible with the exception of excluding fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha). Subjects will be dispensed a Baseline Diet Diary with instructions to record intake 7 days prior to Visit 2 (Week 0). Subjects will also be dispensed a Bowel Habits Diary and Daily GI Tolerance Questionnaire with instructions to complete these during the 7 days prior to Visit 2 (Week 0). Finally, subjects will be dispensed a stool collection kit and will be instructed to collect one fecal sample from one bowel movement during the 3 days prior to Visit 2 (Week 0). Subjects will be reminded that they are not required to fast prior to Visit 2 (Week 0) and will be encouraged to eat breakfast prior to their visit.
At Visit 2 (Week 0), subjects will arrive at the clinic to undergo clinic visit procedures (concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight and vital signs measurements, last menses query, where applicable). Subjects will be queried about compliance with study instructions. The fecal sample will be collected and the Bowel Habits Diary, Baseline Diet Diary, and Daily GI Tolerance Questionnaire will be collected and reviewed. Subjects will be assigned to a randomization sequence. The first study product consumption will occur in the clinic and subject will be dispensed the remaining study products according to their assigned randomization sequence for home consumption (twice a day, once in the morning and once in the evening, with or without food). Subjects who consumed breakfast at home prior to arriving at the clinic will be administered the study product alone while those who did not consume breakfast prior to arriving at the clinic will be administered the study product with a snack. Subjects will also be dispensed a Study Product Diary to record study product intake. Subjects will be dispensed a copy of the last 5 days of their completed Baseline Diet Diary (reviewed at Visit 2, Week 0) and will be instructed to replicate the same food and beverage intake as closely as possible during the days prior to the collection of their fecal sample, which will occur during the 3 days immediately prior to Visit 3 (Week 3). Additionally, subjects will be dispensed 3-day Analysis Diet Records with instructions to record all food and beverages consumed during 3 days (2 weekdays and one weekend) following Visit 2 (Week 0) and before Visit 3 (Week 3) that do not coincide with the 5 replication days immediately prior to Visit 3 (Week 3). Subjects will be dispensed a Bowel Habits Diary and stool collection kit, and will be instructed to complete the Bowel Habits Diary during the 7 days immediately prior to Visit 3 (Week 3) and to collect a fecal sample from one bowel movement during the 3 days immediately prior to Visit 3 (Week 3). Subjects will also be dispensed a Daily GI Tolerance Questionnaire with instructions to complete the questionnaire daily starting from Visit 2 (Week 0) up to Visit 3 (Week 3). Finally, study instructions will also be provided \[(i.e., overnight fasting (12 ± 2 h, water only), maintenance of physical activity with the exception of avoiding vigorous physical activity for 24 h prior; maintenance of habitual diet as much as possible with the exception of avoiding alcohol for 24 h prior and excluding fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha) and consumption of study products\].
At Visit 3 (Week 3), subjects will arrive at the clinic to undergo clinic visit procedures (concomitant medication/supplement use, assess inclusion/exclusion criteria, body weight, and vital signs measurements, last menses query, where applicable) and adverse event (AE) assessments. Subjects will be queried about compliance with study instructions and diet replication. Fasting (12 ± 2 h) blood samples will be collected for chemistry and hematology. Fecal samples will be collected and the Bowel Habits Diary, Daily GI Tolerance Questionnaire, and the 3-day Analysis Diet Record will be collected and reviewed. The Study Product Diary will be collected/reviewed, any unused study products will be collected, and compliance with study product consumption will be assessed. The Product Likeability Questionnaire will be administered in clinic. Subjects will be dispensed a stool collection kit and will be instructed to collect a fecal sample from one bowel movement during the 3 days immediately prior to Visit 4 (Week 5). Subjects will also be dispensed a copy of the last 5 days of their completed Baseline Diet Diary (reviewed at Visit 2, Week 0) and will be instructed to replicate the same food and beverage intake as closely as possible during the days prior to the collection of their fecal sample, which will occur during the 3 days immediately prior to Visit 4 (Week 5). Subjects will also be instructed to begin the 2-week washout period and return to the clinic to begin Test Period 2 at Visit 4 (Week 5). Finally, study instructions will also be provided \[(i.e., maintenance of physical activity; maintenance of habitual diet as much as possible with the exception of excluding fermented foods or beverages that do or might contain live probiotics (e.g., yogurt, kombucha)\]. Subjects will also be reminded that they are not required to fast prior to Visit 4 (Week 5) and will be encouraged to eat breakfast prior to their visit.
At Visit 4 (Week 5), subjects will return to the clinic, crossover to the other study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exception of the randomization procedure. At Visit 5 (Week 8), subjects will repeat the procedures from Visit 3 (Week 3), followed by a 2-week washout period before starting Test Period 3 at Visit 6 (Week 10). At Visit 6 (Week 10), subjects will return to the clinic, crossover to the other study product in their test sequence, and repeat the procedures from Visits 2 (Week 0) with the exception of the randomization procedure. Finally, at Visit 7 (Week 13), subjects will repeat the procedures from Visit 3 (Week 3).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Gastrointestinal Tolerance
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
The study is a randomized, placebo-controlled, crossover, singe-center trial with one screening visit and 3 test periods separated by minimum 2 - week washout periods.
Primary Study Purpose
OTHER
Blinding Strategy
DOUBLE
Participants
Investigators
Study personnel will remain blinded to the sequence assigned to subjects throughout the study. A set of sealed unblinding envelopes will be provided to the Clinical Investigator for use in an emergency situation where a subject's health is at risk.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
7.25 grams of Arabinoxylan leaf fiber extract
Participants are given 7.25 grams of Arabinoxylan daily
Group Type
EXPERIMENTAL
7.25 grams of Arabinoxylan leaf fiber extract
Intervention Type
DIETARY_SUPPLEMENT
Participants are given 7.25 grams of Arabinoxylan daily
14.5 grams of Arabinoxylan leaf fiber extract
Participants are given 14.5 grams of Arabinoxylan daily
Group Type
EXPERIMENTAL
14.5 grams of Arabinoxylan leaf fiber extract
Intervention Type
DIETARY_SUPPLEMENT
Participants are given 14.5 grams of Arabinoxylan daily
Control - No Arabinoxylan (Maltodextrin)
Participants are given no Arabinoxylan
Group Type
PLACEBO_COMPARATOR
Control - No Arabinoxylan
Intervention Type
DIETARY_SUPPLEMENT
Participants are given no Arabinoxylan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
7.25 grams of Arabinoxylan leaf fiber extract
Participants are given 7.25 grams of Arabinoxylan daily
Intervention Type
DIETARY_SUPPLEMENT
14.5 grams of Arabinoxylan leaf fiber extract
Participants are given 14.5 grams of Arabinoxylan daily
Intervention Type
DIETARY_SUPPLEMENT
Control - No Arabinoxylan
Participants are given no Arabinoxylan
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI of 18.5 to 35.0 kg/m2 at Visit 1
* Non- smokers/former users (cessation less than or equal to 12 months)
* Regular bowel movements; not constipated
* Willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial
* Willing to limit alcohol consumption to less than or equal to 2 drinks per day
* Willing to avoid vigorous physical activity for 24 hrs prior to and during visits
* Willing to refrain for exclusionary medications, supplements, and products throughout study.
* Willing to comply with the visit schedule and fecal sample collection/processing/storage requirements
* No health conditions that would prevent him/her from fulfilling the study requirements based on medical history and routine laboratory test results.
* Understands the study procedures and signs forms providing consent and authorization of release of relevant protected health information to investigator
* Non- smokers/former users (cessation less than or equal to 12 months)
* Regular bowel movements; not constipated
* Willing to maintain physical activity patterns, body weight, and habitual diet throughout the trial
* Willing to limit alcohol consumption to less than or equal to 2 drinks per day
* Willing to avoid vigorous physical activity for 24 hrs prior to and during visits
* Willing to refrain for exclusionary medications, supplements, and products throughout study.
* Willing to comply with the visit schedule and fecal sample collection/processing/storage requirements
* No health conditions that would prevent him/her from fulfilling the study requirements based on medical history and routine laboratory test results.
* Understands the study procedures and signs forms providing consent and authorization of release of relevant protected health information to investigator
Exclusion Criteria
* Abnormal laboratory test results of clinical significance at Visit 1
* Clinically important GI condition that would potentially interfere with the evaluation of the study product
* Recent (within 2 weeks of Visit 1) history of an episode of acute GI illness
* Self reported history (within 6 weeks of visit 1) of constipation
* Uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric or biliary disorders
* Uncontrolled hypertension
* Known allergy, intolerances or sensitivity to any of the ingredients in the study product
* Extreme dietary habits
* History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
* Major trauma or any other surgical event within 3 months of Visit 1
* Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1
* Weight loss or gain of greater than 4.5 kg in the 3 months prior to Visit 1
* Currently or planning to be on a weight loss regimen during the duration of the study
* Antibiotic use within 3 months of Visit 1
* Use of steroids within 1 month of Visit 1
* Chronic use of anti-inflammatory medications within 1 month of Visit 1
* Use of medications and or dietary supplements known to influence GI function
* Consumption of fermented foods or beverages that do or might contain live probiotics within 2 weeks of Visit 1
* Participated in endoscopy or endoscopy prep within 3 months of Visit 1
* Female that is pregnant, planning to be pregnant during the study period, lactating, or is unwilling to use a medically approved form of birth control during the study period
* Recent history (within 12 months of screening) of substance abuse
* Has a condition the Investigator believes will interfere with the subjects inability to provide informed consent, confound the interpretation of the results, or put the subject at risk
* Clinically important GI condition that would potentially interfere with the evaluation of the study product
* Recent (within 2 weeks of Visit 1) history of an episode of acute GI illness
* Self reported history (within 6 weeks of visit 1) of constipation
* Uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine, hematologic, immunologic, neurologic, psychiatric or biliary disorders
* Uncontrolled hypertension
* Known allergy, intolerances or sensitivity to any of the ingredients in the study product
* Extreme dietary habits
* History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
* Major trauma or any other surgical event within 3 months of Visit 1
* Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1
* Weight loss or gain of greater than 4.5 kg in the 3 months prior to Visit 1
* Currently or planning to be on a weight loss regimen during the duration of the study
* Antibiotic use within 3 months of Visit 1
* Use of steroids within 1 month of Visit 1
* Chronic use of anti-inflammatory medications within 1 month of Visit 1
* Use of medications and or dietary supplements known to influence GI function
* Consumption of fermented foods or beverages that do or might contain live probiotics within 2 weeks of Visit 1
* Participated in endoscopy or endoscopy prep within 3 months of Visit 1
* Female that is pregnant, planning to be pregnant during the study period, lactating, or is unwilling to use a medically approved form of birth control during the study period
* Recent history (within 12 months of screening) of substance abuse
* Has a condition the Investigator believes will interfere with the subjects inability to provide informed consent, confound the interpretation of the results, or put the subject at risk
Minimum Eligible Age
21 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biofortis, Merieux NutriSciences
INDUSTRY
Sponsor Role
collaborator
Comet Bio Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathleen Kelley, MD
Role: PRINCIPAL_INVESTIGATOR
Biofortis, Merieux NutriSciences
Rich Troyer
Role: STUDY_DIRECTOR
Comet Bio Inc.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.ars.usda.gov/ARSUserFiles/80400530/pdf/1516/Table_1_NIN_GEN_15.pdf
What we eat in America, NHanes 2015-2016
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BIO-1907
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Impact of Dietary Fibre Consumption on Digestive Comfort
NCT05830032
UNKNOWN
NA
Fiber Blends and Gut Microbiota (FB)
NCT04101344
COMPLETED
NA
Gastrointestinal Toleration of Inulin Products
NCT00958529
COMPLETED
NA
The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
NCT02491125
COMPLETED
NA
Bioavailability of Aronia Berry Polyphenols
NCT05488886
COMPLETED
NA
The Antagonistic Effect of Composite Polyphenols on Health Damage Caused by Environmental Pollutants
NCT06437119
COMPLETED
NA
Assessing the Bioavailability of Leading Phytonutrient Products
NCT05349032
UNKNOWN
NA
Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia
NCT02989753
COMPLETED
PHASE1/PHASE2
Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota
NCT06528041
RECRUITING
NA
Characterization of Gut Microbiota Composition and Activity After a Daily Supplementation of 4.5 g/Day of ChitinGlucan Fibre During 3 Weeks in At-cardiometabolic Risk Volunteers
NCT03773900
COMPLETED
NA
Tolerance Profile of Soluble Fibers in Individuals With Self-perceived GI Sensitivity to Fibers (Tarine)
NCT06877013
RECRUITING
NA
Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors
NCT00644098
COMPLETED
PHASE2
Effect of Aged Garlic Extract on Atherosclerosis
NCT01534910
COMPLETED
PHASE4
The Effects of Dietary Fibres on Metabolic Health and the Gut Microbiome
NCT06580132
COMPLETED
NA
A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product
NCT02474953
COMPLETED
PHASE1
Effect of Totum-070 on Lipid Metabolism in Moderate Hypercholesterolemic Subjects
NCT04760951
COMPLETED
NA
Effect of a Dietary Supplement on Lipid Pattern, Indexes of NAFLD and Systemic Inflammation in Healthy Subjects With Suboptimal LDL-C Levels
NCT06403748
NOT_YET_RECRUITING
NA
Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
NCT06188832
COMPLETED
NA
Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.
NCT05016999
COMPLETED
NA
Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
NCT04328571
COMPLETED
NA
Bioavailabity of the Major Metabolites of a Botanical Extract, in Healthy Adults
NCT05098093
COMPLETED
NA
Exploring Mechanism of Action of Dietary Fibre on the Gut Microbiota and Metabolites
NCT05906589
RECRUITING
NA
Artichoke and Bergamot Phytosome
NCT04697121
COMPLETED
NA
Determination of the Bioavailability of Short Chain Fatty Acids in Healthy Humans
NCT01757379
COMPLETED
NA
Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome
NCT03542240
COMPLETED
NA