NCT07158762

Brief Summary

Obesity and increased blood glucose peaks are risk factors for type 2 diabetes mellitus (T2DM). Few studies have explored whether increased body fat contributes to higher blood glucose peaks after food consumption. This study aimed to investigate differences in blood glucose levels between healthy adults with normal weight and those with overweight/obesity after consuming two commercially available breads (white and wholemeal) with different dietary fibre contents. In this study, 20 healthy adults (10 normal weight, 10 overweight/obese) consumed two slices of white bread (100 g, fibre 3.6 g) or wholemeal bread (88 g, fibre 5.6 g) alongside 150 ml of orange juice and 10 g of butter on separate visits in random order after fasting for 8-12 hours. Blood glucose concentration was measured while fasting (before bread consumption) and at 30, 60, 90, and 120 minutes after consumption using finger-prick tests. Information on age, gender, ethnicity, body mass index (BMI), and body fat percentage (BF%) was also collected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

August 26, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

postprandial glycaemic responsebreadbody mass indexbody fat percentage

Outcome Measures

Primary Outcomes (1)

  • Postprandial glycaemic response

    Postprandial blood glucose was measured at 0 (fasting), 30, 60, 90 and 120 minutes by finger prick performed by the researcher using Biosen Blood Glucose/Lactate Analyser (EKF Diagnostics, Cardiff).

    2 hours

Study Arms (2)

Participants with normal weight

ACTIVE COMPARATOR

Healthy participants with a body mass index between 18.5-24.9 kg/m2.

Other: White breadOther: Wholemeal bread

Participants with overweight or obesity

EXPERIMENTAL

Healthy participants with a body mass index ≥ 25 kg/m2

Other: White breadOther: Wholemeal bread

Interventions

Two slices of white bread consumption along with 150 ml of pure orange juice and 10 g of butter

Participants with normal weightParticipants with overweight or obesity

Two slices of wholemeal bread consumption along with 150 ml of pure orange juice and 10 g of butter

Participants with normal weightParticipants with overweight or obesity

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults of 18 - 50 years

You may not qualify if:

  • participants with diabetes
  • digestive system diseases
  • BMI \< 18.5 kg/m2
  • coeliac disease
  • other chronic diseases
  • blood clotting issues
  • those who could not consume the study meals due to food allergies or other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coventry University

Coventry, United Kingdom

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yizhi Xu, PhD

    Coventry University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 8, 2025

Study Start

May 1, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations