Dietary Supplement Clinical Trial
— LORIS-02Official title:
A Randomized, Double-Blind, Comparator-Controlled, Crossover Study to Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With Type 2 Diabetes (T2D) and in Otherwise Healthy Adults With Overweight or Obesity (HAO)
Verified date | July 2023 |
Source | Société des Produits Nestlé (SPN) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy adults with overweight or obesity (HAO).
Status | Completed |
Enrollment | 44 |
Est. completion date | March 28, 2023 |
Est. primary completion date | March 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Type 2 Diabetes (T2D) Inclusion criteria: 1. Willing and able to sign written informed consent prior to study entry. 2. Male or female, >18 years of age. 3. Established diagnosis of T2D (documented by either HbA1c 6.5 - 10.0% or a history of T2D diagnosis). 4. Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening. 5. Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males. 6. Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males. Exclusion Criteria: 1. Type 1 diabetes. 2. Known food allergy or intolerance to study products. 3. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments. 4. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily. 5. Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures 4 weeks prior to dosing. 6. Current use of injectable insulin therapy, any other oral (other than metformin) or injectable glucose-lowering drug. Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues). 7. Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors). 8. Current treatment with systemic steroids (application of inhaled or topical steroids is permitted). 9. Recent episode of an acute gastrointestinal illness. 10. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer. 11. Current daily cigarette smoking. 12. Are unable to comply with protocol procedures in the opinion of the investigator. 13. Have a hierarchical link with the research team members. 14. Positive pregnancy test or breast-feeding at screening. 15. Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening. 16. Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit. HAO: Otherwise Healthy Adults (HAO) with overweight or obese but who DO NOT present with a confirmed diagnosis of diabetes mellitus Inclusion criteria: 1. Willing and able to sign written informed consent prior to study entry. 2. Male or female, >18 years of age. 3. BMI = 25 kg/m2. 4. Fasting plasma glucose (FPG) = 125 mg/dL. Exclusion criteria: 1. Type 1 or type 2 diabetes (including those potentially detected at screening). 2. 2-h plasma glucose = 200 mg/dL - if measured within 6 weeks prior to screening. 3. Known food allergy or intolerance to study products. 4. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments. 5. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily. 6. Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior to dosing. 7. Current use of injectable insulin therapy, any oral or injectable glucose-lowering drug. 8. Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues). 9. Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors). 10. Current treatment with systemic steroids (application of inhaled or topical steroids is permitted). 11. Recent episode of an acute gastrointestinal illness. 12. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer. 13. Current daily cigarette smoking. 14. Are unable to comply with protocol procedures in the opinion of the investigator. 15. Positive pregnancy test or breast-feeding at screening. 16. Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening. 17. Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit. |
Country | Name | City | State |
---|---|---|---|
United States | Orange County Research Center | Tustin | California |
Lead Sponsor | Collaborator |
---|---|
Société des Produits Nestlé (SPN) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Plasma glucose at individual timepoints | Over the course of 3 hours following study product intake | ||
Other | Between-group comparison of changes in glucose slope | From the time point at which maximum glucose level is measured to 3 hours | ||
Other | Between group comparison of mean "Interquartile range" | IQR is defined as the difference between mean Q1 and mean Q3 glucose levels (mmol/L) | Over the course of 3 hours following study product intake | |
Other | Serum insulin at individual timepoints | Over the course of 3 hours following study product intake | ||
Other | Plasma glucagon-like peptide 1 (GLP-1) at individual timepoints | Over the course of 2 hours following study product intake | ||
Other | Plasma peptide tyrosine (PYY) at individual timepoints | Over the course of 2 hours following study product intake | ||
Other | Plasma glucagon-like peptide 1 (GLP-1) | Over the course of 1 hour following study product intake | ||
Other | Plasma peptide tyrosine (PYY) | Over the course of 1 hour following study product intake | ||
Primary | Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours. | Comparisons in the T2D group: 50 g Oligomalt vs 50 g Glucidex 40. Comparisons in the HAO group: 33 g Oligomalt vs 33 g Glucidex 40 and 50 g Oligomalt vs 50 g Glucidex 40. | Over the course of 3 hours following study product intake | |
Secondary | Total blood glucose AUC | Over the course of 3 hours following study product intake | ||
Secondary | Blood glucose (iCmax) | Maximum blood glucose level | Over the course of 3 hours following study product intake | |
Secondary | Blood glucose (Cmin) | Minimum blood glucose level | Over the course of 3 hours following study product intake | |
Secondary | Blood glucose (Tmax) | Time point at which maximum blood glucose level is measured | Over the course of 3 hours following study product intake | |
Secondary | Blood glucose (Tmin) | Time point at which minimum blood glucose level is measured | Over the course of 3 hours following study product intake | |
Secondary | Number of participants with glucose levels less than or equal to 3.9 mmol/L | Over the course of 3 hours following study product intake | ||
Secondary | Number of participants with glucose levels less than or equal to 3.1 mmol/L | Over the course of 3 hours following study product intake | ||
Secondary | Serum insulin level | Over the course of 3 hours following study product intake | ||
Secondary | Insulinogenic index (IGI) | A measure of early ß-cell capacity (first- phase insulin response) | 30 minutes | |
Secondary | Insulin index | Over the course of 2 hours following study product intake | ||
Secondary | Matsuda Index (MI) | Over the course of 2 hours following study product intake | ||
Secondary | Plasma glucagon-like peptide 1 (GLP-1) | Over the course of up to 3 hours following study product intake | ||
Secondary | Plasma peptide tyrosine (PYY) | Over the course of up to 3 hours following study product intake |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04639726 -
A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response.
|
N/A | |
Recruiting |
NCT05738746 -
The Efficacy of Pasteurised Akkermansia Muciniphila in Healthy Medical Workers
|
N/A | |
Completed |
NCT01462058 -
The Role of Vitamin D Supplementation on Well Being and Symptoms of Depression During the Winter Season in Health Service Staff
|
Phase 4 | |
Completed |
NCT05210244 -
Acute Beetroot Juice Supplementation in Amateur Climbers
|
N/A | |
Not yet recruiting |
NCT06433310 -
Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study
|
Early Phase 1 | |
Completed |
NCT05337527 -
Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults
|
N/A | |
Active, not recruiting |
NCT04429737 -
The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients
|
N/A | |
Completed |
NCT04210531 -
Beetroot Juice Supplementation in Basketball Players
|
N/A | |
Recruiting |
NCT05941949 -
Nutritional Supplement's Effects on Cognition
|
N/A | |
Completed |
NCT04877366 -
Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia
|
N/A | |
Recruiting |
NCT03998306 -
Probiotics in Children With Early Childhood Caries
|
N/A | |
Completed |
NCT05984771 -
Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study
|
N/A | |
Completed |
NCT05880186 -
Influence of the Time of Day in the Effect of Caffeine on Maximal Fat Oxidation During Exercise in Women
|
N/A | |
Completed |
NCT03418376 -
Carnosine Loading and Periodized Training in MS and HC
|
N/A | |
Completed |
NCT03395119 -
Efficacy of Fish Oil or Olive Oil Supplementation on the Health Effects of Ozone Exposure in Healthy Young Subjects
|
Phase 1 | |
Completed |
NCT04761406 -
Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management
|
N/A | |
Completed |
NCT04832412 -
Effect of BrainPhyt, a Microalgae Based Ingredient on Cognitive Function in Healthy Older Subjects
|
N/A | |
Recruiting |
NCT04438486 -
Effects of Barley Green in Patients With Hyperuricemia
|
N/A |