NCT05628584

Brief Summary

This is a prospective, double blinded, randomised cross over feeding trial examine high or low FODMAP diet in combination with metformin on postprandial glucose responses and gastrointestinal tolerability and gut microbiota profiles. The trial will compare high or low FODMAP diet, each of 10 days duration in combination with 5 days metformin, separated by a washout period of at least 2 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

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

First Submitted

Initial submission to the registry

November 8, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

March 5, 2025

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

November 8, 2022

Last Update Submit

March 2, 2025

Conditions

PreDiabetesImpaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Differences in postprandial glycemia

    incremental area under curve on continuous glucose monitoring post meal

    10 days

Secondary Outcomes (6)

  • Glucose response to 75g oral glucose tolerance test

    10 days

  • Insulin response to 75g oral glucose tolerance test

    10 days

  • Change in alpha diversity of gut microbiota

    10 days

  • Change in beta diversity of gut microbiota

    10 days

  • Body weight

    10 days

  • +1 more secondary outcomes

Study Arms (2)

High FODMAP

EXPERIMENTAL
Combination Product: High FODMAP diet with metformin

LOW FODMAP

PLACEBO COMPARATOR
Combination Product: Low FODMAP diet with metformin

Interventions

High FODMAP diet with metforminCOMBINATION_PRODUCT

Controlled High FODMAP diet (15g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period

High FODMAP
Low FODMAP diet with metforminCOMBINATION_PRODUCT

Controlled low FODMAP diet (3g/day) from day 1-10, metformin XR 1000mg daily day 6-10 for each treatment period

LOW FODMAP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Body mass index 18 to 40 kg/m 2
  • Prediabetes defined as impaired fasting PG 5.6-6.9 mmol/l and/or impaired glucose tolerance with 2-hour PG 7.8-11.1 mmol/l on 75g oral glucose tolerance test (OGTT) and/or HbA1c 5.7-6.4% at screening

You may not qualify if:

  • Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
  • Known current diabetes
  • Current or previous use of glucose-lowering or weight loss drugs in 3 months prior to screening
  • Concurrent participation in other weight loss or lifestyle intervention programmes
  • Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  • Recent intake of prebiotic/probiotic or antibiotic, immunosuppressants (within 8 weeks of randomisation)
  • Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
  • Known uncontrolled thyrotoxicosis
  • Known vitamin B deficiency
  • Known irritable bowel syndrome or gastrointestinal disorders
  • Estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 at screening
  • Current use of steroids
  • Have a known allergy to medical-grade adhesives
  • Known current or recent alcohol or drug abuse
  • Hypersensitivity to metformin
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (1)

  • Chu NHS, Ling J, Poon EWM, Lee JYS, Song Q, Zuo Z, Muir J, Chan JCN, Chow E. Combining a diet rich in fermentable carbohydrates with metformin improves glycaemic control and reshapes the gut microbiota in people with prediabetes. Nat Metab. 2025 Aug;7(8):1614-1629. doi: 10.1038/s42255-025-01336-4. Epub 2025 Jul 31.

    PMID: 40745466DERIVED

MeSH Terms

Conditions

Prediabetic StateGlucose Intolerance

Interventions

MetforminFODMAP Diet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsElimination DietsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 28, 2022

Study Start

November 11, 2022

Primary Completion

August 25, 2023

Study Completion

October 15, 2023

Last Updated

March 5, 2025

Record last verified: 2022-11

Locations

HK(1)