Effect of a Sugar Replacement on Blood Glucose Levels in Healthy Adults

NCT06714552 | Recruiting

• 1 other identifier: SURE-BloG
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Hyperglycemia; Hyperinsulinemia

Keywords

galacto-oligosaccharides; postprandial glycaemia; GOS

Outcome Measures

Primary Outcomes (1)

• Difference in plasma glucose incremental area under the curve (iAUC) between study arms

  Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. iAUC will be calculated using the trapezoidal rule with the baseline value of fasting plasma glucose subtracted.

  10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

Secondary Outcomes (6)

• Difference in plasma glucose total area under the curve (tAUC) between study arms

  10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

• Difference in peak plasma glucose concentration between study arms

  10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

• Measured maximal incremental glucose value (iCMax) between study arms

  10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption

• Difference in plasma insulin iAUC between study arms

  baseline, 30, 60, 120 min after beverage consumption

• Difference in plasma insulin tAUC between study arms

  baseline, 30, 60, 120 min after beverage consumption

Study Arms (2)

Beta-galacto-oligosaccharide

EXPERIMENTAL

Dietary Supplement: Galacto-Oligosaccharide

Glucose

OTHER

Control

Other: Glucose

Interventions

Galacto-Oligosaccharide DIETARY_SUPPLEMENT

24.0 g Oligomate® in 100 mL water

Beta-galacto-oligosaccharide

Glucose OTHER

17.8 g glucose in 100 mL water

Glucose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• Yakult Honsha Co., LTD: collaborator

Study Sites (1)

University of Aberdeen, Rowett Institute

Aberdeen, AB25 2ZD, United Kingdom

RECRUITING

Related Publications (18)

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  PMID: 17992183 BACKGROUND

• 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.

  PMID: 16494646 BACKGROUND

• 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.

  PMID: 22780564 BACKGROUND

• 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.

  PMID: 20213326 BACKGROUND

• Bonora E. Postprandial peaks as a risk factor for cardiovascular disease: epidemiological perspectives. Int J Clin Pract Suppl. 2002 Jul;(129):5-11.

  PMID: 12166607 BACKGROUND

• 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.

  PMID: 15505129 BACKGROUND

• 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.

  PMID: 27798656 BACKGROUND

• 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.

  PMID: 26487791 BACKGROUND

• 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.

  PMID: 33897622 BACKGROUND

• 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.

  PMID: 33208922 BACKGROUND

• 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.

  PMID: 73796 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24688953 BACKGROUND

• 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.

  PMID: 10827212 BACKGROUND

• 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.

  PMID: 26645521 BACKGROUND

• 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.

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• 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.

  PMID: 31983281 BACKGROUND

• 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.

  PMID: 28255654 BACKGROUND

Related Links

• Indicator Metadata Registry List: Mean fasting blood glucose
• Scientific Opinion on Dietary Reference Values for carbohydrates and dietary fibre
• Scientific Opinion on the substantiation of a health claim related to AlphaGOS® and a reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006
• Noncommunicable diseases

MeSH Terms

Conditions

Hyperglycemia; Hyperinsulinism

Interventions

4'-galactooligosaccharide; Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Karen Scott, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Scott, PhD

CONTACT

+44 (0)1224 438730; k.scott@abdn.ac.uk

Galiana Lo, PhD

CONTACT

+44 (0)1224 438771; galianatakyan.lo1@abdn.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Statistician
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 3, 2024
• Study Start: January 17, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)