Effect of a Sugar Replacement on Blood Glucose Levels in Healthy Adults (SURE-BloG)

June 17, 2026 updated by: University of Aberdeen

Effect of the Replacement of Glycaemic Carbohydrates With Galacto-Oligosaccharide (GOS) Supplementation on Postprandial Glycaemic Response in Healthy Adults

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZD
        • University of Aberdeen, Rowett Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beta-galacto-oligosaccharide
Dietary supplement: Galacto-Oligosaccharide
24.0 g Oligomate® in 100 mL water
Other: Glucose
Control
Other: Glucose
17.8 g glucose in 100 mL water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in plasma glucose incremental area under the curve (iAUC) between study arms
Time Frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in plasma glucose total area under the curve (tAUC) between study arms
Time Frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. tAUC will be calculated using the trapezoidal rule with zero as the baseline.
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
Time Frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. The peak plasma glucose concentrations for each arm will be compared.
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
Time Frame: 10 and 5 min before beverage consumption, 15, 30, 45, 60, 90, 120 min after beverage consumption
Plasma glucose levels obtained from blood samples collected before and after beverage consumption will be determined using an automated clinical analyser. iCMax will be calculated using fasting plasma glucose levels as baseline.
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
Time Frame: baseline, 30, 60, 120 min after beverage consumption

Plasma insulin levels will be determined using ELISA from blood samples obtained, at several time points.

iAUC will be calculated using the trapezoidal rule with baseline value of fasting plasma insulin subtracted.
baseline, 30, 60, 120 min after beverage consumption
Difference in plasma insulin tAUC between study arms
Time Frame: baseline, 30, 60, 120 min after beverage consumption
Plasma insulin levels will be determined using ELISA from blood samples obtained at several time points. tAUC will be calculated using the trapezoidal rule with zero as the baseline.
baseline, 30, 60, 120 min after beverage consumption
Difference in peak plasma insulin concentration between study arms
Time Frame: baseline, 30, 60, 120 min after beverage consumption
Plasma insulin will be determined using ELISA from blood samples obtained at several time points. Peak plasma insulin levels for each arm will be compared.
baseline, 30, 60, 120 min after beverage consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

Yakult Honsha Co., LTD

Investigators

  • Principal Investigator: Karen Scott, PhD, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2025

Primary Completion (Actual)

April 13, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURE-BloG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study is designed to look at average responses to the supplement. There is no need to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperinsulinemia

Clinical Trials on Galacto-Oligosaccharide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe