Glucose Tolerance Clinical Trial
Official title:
Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota
Verified date | March 2019 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans
Status | Completed |
Enrollment | 18 |
Est. completion date | February 28, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - healthy adults - BMI<30 - non smokers - consuming a non-vegetarian diet that follows the Nordic guidances Exclusion Criteria: - fasting blood glucose >6.1 mmol/L - known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study. |
Country | Name | City | State |
---|---|---|---|
Sweden | Food Technology, engineering and Nutrition, LTH, Lund University | Lund |
Lead Sponsor | Collaborator |
---|---|
Lund University | Öste Venture AB, Vinnova |
Sweden,
Kovatcheva-Datchary P, Nilsson A, Akrami R, Lee YS, De Vadder F, Arora T, Hallen A, Martens E, Björck I, Bäckhed F. Dietary Fiber-Induced Improvement in Glucose Metabolism Is Associated with Increased Abundance of Prevotella. Cell Metab. 2015 Dec 1;22(6):971-82. doi: 10.1016/j.cmet.2015.10.001. Epub 2015 Nov 6. — View Citation
Nilsson AC, Johansson-Boll EV, Björck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11. — View Citation
Nilsson AC, Ostman EM, Holst JJ, Björck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. — View Citation
Nilsson AC, Östman EM, Knudsen KE, Holst JJ, Björck IM. A cereal-based evening meal rich in indigestible carbohydrates increases plasma butyrate the next morning. J Nutr. 2010 Nov;140(11):1932-6. doi: 10.3945/jn.110.123604. Epub 2010 Sep 1. — View Citation
Sandberg JC, Björck IM, Nilsson AC. Rye-Based Evening Meals Favorably Affected Glucose Regulation and Appetite Variables at the Following Breakfast; A Randomized Controlled Study in Healthy Subjects. PLoS One. 2016 Mar 18;11(3):e0151985. doi: 10.1371/journal.pone.0151985. eCollection 2016. — View Citation
Sandberg JC, Björck IME, Nilsson AC. Effects of whole grain rye, with and without resistant starch type 2 supplementation, on glucose tolerance, gut hormones, inflammation and appetite regulation in an 11-14.5 hour perspective; a randomized controlled study in healthy subjects. Nutr J. 2017 Apr 21;16(1):25. doi: 10.1186/s12937-017-0246-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Subjective appetite sensations | determined with VAS (visual analogue scale) scales (0-100 mm) | 0-14 h after intake | |
Other | mood (valence and activity) | determined with VAS scales (0-100 mm) | 0-14 h after intake | |
Other | Energy intake | ad libitum intake at a second meal after intake of test products | 4 h after intake of a test product or the control product | |
Other | breath hydrogen concentrations | indicator of gut fermentation | 0-14 h after intake | |
Primary | Blood glucose regulation | Postprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products. | 0-14 h after intake | |
Secondary | serum insulin | Postprandial serum insulin concentrations (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products. | 0-14 h after intake | |
Secondary | gut microbiota composition | effects on gut microbiota composition after intake of prebiotics | first stool delivered from14 h after intake | |
Secondary | plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin | Gastro-intestinale hormones involved in appetite and metabolic regulation | 0-14 h after intake | |
Secondary | plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor) | Inflammatory markers in blood | 0-14 h after intake | |
Secondary | plasma GLP-2 | gut hormone involved in gut mucosa integrity | 0-14 h after intake | |
Secondary | plasma SCFA (short-chain fatty acid) | colonic fermentation metabolites | 0-14 h after intake | |
Secondary | blood lipids | cholesterol and free fatty acids in plasma | 0-14 h after intake | |
Secondary | plasma adiponectin | hormone involved in metabolic regulation | 0-14 h after intake | |
Secondary | plasma BDNF (Brain-derived neurotrophic factor) | signal protein important for brain functions, but also involved in metabolic regulation | 0-14 h after intake | |
Secondary | plasma neurotensin | a neuro peptide peptides involved in appetite and metabolic regulation | 0-14 h after intake | |
Secondary | plasma Nesfatin-1 | a neuro peptide that participates in the regulation of hunger and fat storage. | 0-14 h after intake |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02913079 -
The Acute Impact of Sit-stand Desks on Post-meal Blood Sugar Levels
|
N/A | |
Completed |
NCT02065271 -
Herbal Preparation and Glucose Homeostasis
|
N/A | |
Completed |
NCT00985270 -
Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis
|
Phase 4 | |
Completed |
NCT01705639 -
Melatonin and Glucose Tolerance Among Individuals With a Variant of the MTNR1B Gene
|
Phase 3 | |
Active, not recruiting |
NCT01798030 -
Vitamin D Retrospective Study and Role With Disease
|
||
Completed |
NCT06193291 -
Effect of Hot Water Immersion on Heart Rate Variability and Glucose
|
N/A | |
Recruiting |
NCT05300256 -
Peripheral Heating and Glucose Tolerance
|
N/A | |
Completed |
NCT04439630 -
Effects of Nopal Fractions on Postprandial Glucose Regulation and Appetite Variables in Healthy Humans
|
N/A | |
Completed |
NCT03714438 -
Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults
|
Phase 2 | |
Completed |
NCT00628524 -
Homburg Cream & Sugar Study
|
N/A | |
Recruiting |
NCT03725969 -
Effect of Camel Milk on Insulin and Incretin Response
|
N/A | |
Completed |
NCT03872557 -
Modulating Glucose Tolerance With Dietary Tyrosine
|
N/A | |
Recruiting |
NCT04966299 -
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
|
N/A | |
Completed |
NCT04904133 -
Effects of Low/No Calorie Sweeteners on Glucose Tolerance
|
N/A |