Clinical trial NCT06714552: Effect of a Sugar Replacement on Blood Glucose Levels in Healthy Adults
Official title: Effect of the Replacement of Glycaemic Carbohydrates With Galacto-Oligosaccharide (GOS) Supplementation on Postprandial Glycaemic Response in Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postprandial Hyperglycemia
Hyperinsulinemia
Keywords: galacto-oligosaccharides
postprandial glycaemia
GOS
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: Yakult Honsha Co., LTD
First posted: 2024-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Diabetes and cardiovascular disease account for millions of deaths per year. One of the risk factors for both conditions is high blood sugar, particularly after eating (postprandial hyperglycaemia). Lowering blood sugar levels after a meal is expected to have a positive effect on preventing metabolic and cardiovascular diseases and improving the metabolic control of those who already suffer from these conditions.

The aim of this study is to investigate the effect of Oligomate® (beta-galacto-oligosaccharide) on postprandial glycaemia when used as a partial replacement of glycaemic carbohydrates in a beverage in otherwise healthy volunteers. Volunteers will be given water with either Oligomate® or glucose (control) added. Blood samples will be collected at eight time points (two before drinking the beverage and six after) to measure glucose and insulin levels.

Detailed description: A single-centre, single-blind, randomised, controlled, cross-over, acute feeding trial will be conducted. The recruitment and study visits will be carried out at the Human Intervention Studies Unit (HISU) of the Rowett Institute.

A recruitment visit will be scheduled to screen for eligibility. During the visit, informed consent will be obtained before volunteers complete a health questionnaire, have their height and weight measured, and their veins checked to assess suitability for blood sample collection. A finger prick blood sample will then be taken to measure HbA1c levels. If a volunteer is eligible, the first study visit will be scheduled and they will be asked to fast for 12 hours the night before. A frozen high carbohydrate vegetarian ready-meal will be provided, which they will consume at home the evening before the study visit and before the fasting period.

During the study visits, the postprandial glycaemic response will be measured immediately after consumption of the supplement or control on two occasions separated by a wash-out period of 7-14 days. Briefly, subjects will arrive in the morning after having consumed the high carbohydrate meal the night before, followed by a 12 hr overnight fast. After recording body weight, a cannula will be inserted into an antecubital vein of one arm by a trained cannulist to allow repeated blood sampling during the assessment (approx. 6 ml collected per sample time to a total of 48 ml per visit). After obtaining two initial fasting blood samples (at -10min and -5min), subjects will consume the test beverage within 5 min. Further blood samples will be obtained at 15, 30, 45, 60, 90 and 120 min after ingestion to complete the postprandial glycaemic response assessment.

At the end of the first visit volunteers will receive the second ready-meal, identical to the first, which they will be asked to consume the evening before the second study visit, before the fasting period commences. During the second study visit, participants will consume the same beverage with the alternate supplement and complete the opposite arm of the postprandial glycaemic response assessment.

Eligibility criteria: Inclusion Criteria:

* Healthy Men or Women
* Body Mass Index (BMI) 18.5-29.9 kg/m\^2
* Between 18 and 65 years of age
* Compliant (i.e., understands and is willing, able, and likely to comply with the experimental procedure and safety guidelines)
* Able to provide informed consent
* Premenopausal women must have a regular cycle or be on hormonal contraception.

Exclusion Criteria:

* Diabetes mellitus (all types including gestational diabetes)
* HbA1c result over the study limit \[healthy range of between 4% and 5.9%\]
* Endocrine disease (e.g., Cushing's syndrome)
* Any food allergy or intolerance, or following Vegan diet
* Medications that increase blood glucose (e.g., steroids, protease inhibitors, antipsychotics, antihypertensives, statins, diuretics, nicotinic acid, etc.)
* Medications that lower glycemia (e.g., anti-hyperglycaemics, insulin, beta- blockers, etc.)
* Medication affecting glucose regulation, appetite, and/or digestion/absorption of nutrients, antibiotics
* Major medical or surgical event requiring hospitalization in the previous 3 months
* Pregnant or lactating
* Participation in another clinical/supplementation trial or actively trying to reduce body weight
* Unable to comply with experimental procedures and safety guidelines
* Unable to give consent
* Smokers
* Travel during the study period

Primary outcomes:
measure: Difference in plasma glucose incremental area under the curve (iAUC) between study arms
timeFrame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
Secondary outcomes:
measure: Difference in plasma glucose total area under the curve (tAUC) between study arms
timeFrame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
measure: Difference in peak plasma glucose concentration between study arms
timeFrame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
measure: Measured maximal incremental glucose value (iCMax) between study arms
timeFrame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
measure: Difference in plasma insulin iAUC between study arms
timeFrame: baseline, 30, 60, 120 min after beverage consumption
measure: Difference in plasma insulin tAUC between study arms
timeFrame: baseline, 30, 60, 120 min after beverage consumption
measure: Difference in peak plasma insulin concentration between study arms
timeFrame: baseline, 30, 60, 120 min after beverage consumption
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen, Rowett Institute
Study officials:
affiliation: University of Aberdeen
name: Karen Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Venn BJ, Green TJ. Glycemic index and glycemic load: measurement issues and their effect on diet-disease relationships. Eur J Clin Nutr. 2007 Dec;61 Suppl 1:S122-31. doi: 10.1038/sj.ejcn.1602942.
citation: Wright E Jr, Scism-Bacon JL, Glass LC. Oxidative stress in type 2 diabetes: the role of fasting and postprandial glycaemia. Int J Clin Pract. 2006 Mar;60(3):308-14. doi: 10.1111/j.1368-5031.2006.00825.x.
citation: Blaak EE, Antoine JM, Benton D, Bjorck I, Bozzetto L, Brouns F, Diamant M, Dye L, Hulshof T, Holst JJ, Lamport DJ, Laville M, Lawton CL, Meheust A, Nilson A, Normand S, Rivellese AA, Theis S, Torekov SS, Vinoy S. Impact of postprandial glycaemia on health and prevention of disease. Obes Rev. 2012 Oct;13(10):923-84. doi: 10.1111/j.1467-789X.2012.01011.x. Epub 2012 Jul 11.
citation: Neri S, Calvagno S, Mauceri B, Misseri M, Tsami A, Vecchio C, Mastrosimone G, Di Pino A, Maiorca D, Judica A, Romano G, Rizzotto A, Signorelli SS. Effects of antioxidants on postprandial oxidative stress and endothelial dysfunction in subjects with impaired glucose tolerance and type 2 diabetes. Eur J Nutr. 2010 Oct;49(7):409-16. doi: 10.1007/s00394-010-0099-6. Epub 2010 Mar 7.
citation: Bonora E. Postprandial peaks as a risk factor for cardiovascular disease: epidemiological perspectives. Int J Clin Pract Suppl. 2002 Jul;(129):5-11.
citation: Levitan EB, Song Y, Ford ES, Liu S. Is nondiabetic hyperglycemia a risk factor for cardiovascular disease? A meta-analysis of prospective studies. Arch Intern Med. 2004 Oct 25;164(19):2147-55. doi: 10.1001/archinte.164.19.2147.
citation: Lin PJ, Borer KT. Third Exposure to a Reduced Carbohydrate Meal Lowers Evening Postprandial Insulin and GIP Responses and HOMA-IR Estimate of Insulin Resistance. PLoS One. 2016 Oct 31;11(10):e0165378. doi: 10.1371/journal.pone.0165378. eCollection 2016.
citation: Hinnen DA. Therapeutic Options for the Management of Postprandial Glucose in Patients With Type 2 Diabetes on Basal Insulin. Clin Diabetes. 2015 Oct;33(4):175-80. doi: 10.2337/diaclin.33.4.175.
citation: Kamruzzaman M, Horowitz M, Jones KL, Marathe CS. Gut-Based Strategies to Reduce Postprandial Glycaemia in Type 2 Diabetes. Front Endocrinol (Lausanne). 2021 Apr 9;12:661877. doi: 10.3389/fendo.2021.661877. eCollection 2021.
citation: Gill SK, Rossi M, Bajka B, Whelan K. Dietary fibre in gastrointestinal health and disease. Nat Rev Gastroenterol Hepatol. 2021 Feb;18(2):101-116. doi: 10.1038/s41575-020-00375-4. Epub 2020 Nov 18.
citation: Jenkins DJ, Goff DV, Leeds AR, Alberti KG, Wolever TM, Gassull MA, Hockaday TD. Unabsorbable carbohydrates and diabetes: Decreased post-prandial hyperglycaemia. Lancet. 1976 Jul 24;2(7978):172-4. doi: 10.1016/s0140-6736(76)92346-1.
citation: Bonsu NKA, Johnson S. Effects of inulin fibre supplementation on serum glucose and lipid concentration in patients with type 2 diabetes. International Journal of Diabetes and Metabolism. 2012 12;20(3):80-6. doi: 10.1159/000497730.
citation: Dehghan P, Pourghassem Gargari B, Asgharijafarabadi M. Effects of high performance inulin supplementation on glycemic status and lipid profile in women with type 2 diabetes: a randomized, placebo-controlled clinical trial. Health Promot Perspect. 2013 Jun 30;3(1):55-63. doi: 10.5681/hpp.2013.007. eCollection 2013.
citation: Luo J, Van Yperselle M, Rizkalla SW, Rossi F, Bornet FR, Slama G. Chronic consumption of short-chain fructooligosaccharides does not affect basal hepatic glucose production or insulin resistance in type 2 diabetics. J Nutr. 2000 Jun;130(6):1572-7. doi: 10.1093/jn/130.6.1572.
citation: Gargari BP, Namazi N, Khalili M, Sarmadi B, Jafarabadi MA, Dehghan P. Is there any place for resistant starch, as alimentary prebiotic, for patients with type 2 diabetes? Complement Ther Med. 2015 Dec;23(6):810-5. doi: 10.1016/j.ctim.2015.09.005. Epub 2015 Sep 16.
citation: Liu F, Li P, Chen M, Luo Y, Prabhakar M, Zheng H, He Y, Qi Q, Long H, Zhang Y, Sheng H, Zhou H. Fructooligosaccharide (FOS) and Galactooligosaccharide (GOS) Increase Bifidobacterium but Reduce Butyrate Producing Bacteria with Adverse Glycemic Metabolism in healthy young population. Sci Rep. 2017 Sep 18;7(1):11789. doi: 10.1038/s41598-017-10722-2.
citation: Muller M, Hermes GDA, Emanuel E C, Holst JJ, Zoetendal EG, Smidt H, Troost F, Schaap FG, Damink SO, Jocken JWE, Lenaerts K, Masclee AAM, Blaak EE. Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. Gut Microbes. 2020 Nov 9;12(1):1704141. doi: 10.1080/19490976.2019.1704141. Epub 2020 Jan 25.
citation: Lightowler H, Thondre S, Holz A, Theis S. Replacement of glycaemic carbohydrates by inulin-type fructans from chicory (oligofructose, inulin) reduces the postprandial blood glucose and insulin response to foods: report of two double-blind, randomized, controlled trials. Eur J Nutr. 2018 Apr;57(3):1259-1268. doi: 10.1007/s00394-017-1409-z. Epub 2017 Mar 3.