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Effect of Fibre Supplements on Gestational Diabetes

NCT03547960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-06

Study results available
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Summary

The primary aim of this study is to evaluate the effect of a soluble fibre supplement in the development of gestational diabetes in women at high-risk. The secondary aim will be to evaluate the effect of the soluble fibre supplement on glycaemic control in high-risk women who develop gestational diabetes in early pregnancy.

DESIGN The study plans to conduct a randomised open label controlled study to evaluate the effect of the consumption of soluble fibre, from early to mid-pregnancy, on the incidence of gestational diabetes, insulin sensitivity, insulin secretion and metabolic control in GDM diagnosed participants.

POPULATION The study team will be studying women with diagnosis of gestational diabetes in previous pregnancies, (considered as high-risk) aged \>18 years.

TREATMENT Participants in the treatment arms will be 5 gr of Guar gum fibre supplement with meals three times a day (total daily 15 g). Participants in the placebo arms will be taking 5 gr of Cellulose three times a day (total daily dose 15 g).

DURATION Participants will be involved for 12 weeks.

OUTCOMES Primary outcome: In women with 16-week negative OGTT, GDM at 28 weeks

Conditions

  • Gestational Diabetes

Interventions

DIETARY_SUPPLEMENT

Guar gum

Fibre supplement to be taken with each meal

DIETARY_SUPPLEMENT

Cellulose

Placebo. Fibre supplement to be taken with each meal

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Gary Frost, PhD · Chair of Nutrition. Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2021-03-17
Completion
2021-03-17

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547960 on ClinicalTrials.gov