Trial Outcomes & Findings for Effect of Fibre Supplements on Gestational Diabetes (NCT NCT03547960)

Results Overview

An Oral glucose tolerance test will be performed. Gestational diabetes will be diagnosed if fasting plasma glucose \>=5.3 and or 120 min plasma glucose \>=7.8

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Guar Gum 5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Guar gum: Fibre supplement to be taken with each meal	Control/Cellulose 5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Cellulose: Placebo. Fibre supplement to be taken with each meal
Overall Study STARTED	30	30
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	20	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Fibre Supplements on Gestational Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guar Gum n=22 Participants 5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Guar gum: Fibre supplement to be taken with each meal	Control/Cellulose n=19 Participants 5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Cellulose: Placebo. Fibre supplement to be taken with each meal	Total n=41 Participants Total of all reporting groups
Age, Continuous	35.1 years STANDARD_DEVIATION 4.8 • n=5 Participants	32.6 years STANDARD_DEVIATION 4.4 • n=7 Participants	34.0 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized Non-caucasian	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment United Kingdom	22 participants n=5 Participants	19 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

An Oral glucose tolerance test will be performed. Gestational diabetes will be diagnosed if fasting plasma glucose \>=5.3 and or 120 min plasma glucose \>=7.8

Outcome measures

Outcome measures
Measure	Guar Gum n=10 Participants 5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Guar gum: Fibre supplement to be taken with each meal	Control/Cellulose n=10 Participants 5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Cellulose: Placebo. Fibre supplement to be taken with each meal
Numbers Diagnosed With Gestational Diabetes	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 12 weeks

Insulin sensitivity will be assessed using the Matsuda index (is an whole body insulin sensitivity index that reflects a composite estimate of hepatic and muscle insulin sensitivity) in line with the following modified Matsuda equation in which insulin is substituted by the serum concentration of C-peptide for estimation purposes. In the the above index scale a lower number indicates lower sensitivity. Equation: ISOGTTC-pep=500,000/√{\[FPGxFsC-pep\] x \[mean glucose x mean sC-pep during the OGTT\]} There is no maximum or minum

Outcome measures

Outcome measures
Measure	Guar Gum n=22 Participants 5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Guar gum: Fibre supplement to be taken with each meal	Control/Cellulose n=19 Participants 5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Cellulose: Placebo. Fibre supplement to be taken with each meal
Comparison of Insulin Sensitivity Between the 2 Experimental Groups (Gur and Cellulose Groups)	269.7 score on a scale Standard Deviation 141.6	324.2 score on a scale Standard Deviation 210.3

SECONDARY outcome

Timeframe: 12 weeks

HOMA-IR is a model that uses the static concentrations of fasting glucose and insulin for determination of insulin resistance and pancreatic beta-cell function. In the the above model scale a lower number indicates lower secretion. The validity of HOMA-IR index is lower in patients with low body mass index (BMI), low-activity of beta cells and high levels of blood glucose Homa IR =fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. There is no maximum or minimum

Outcome measures

Outcome measures
Measure	Guar Gum n=22 Participants 5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Guar gum: Fibre supplement to be taken with each meal	Control/Cellulose n=19 Participants 5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Cellulose: Placebo. Fibre supplement to be taken with each meal
Comparison of Insulin Secretion Between the 2 Experimental Groups (Guar and Cellulose)	433.9 score on a scale Standard Deviation 377.5	479.8 score on a scale Standard Deviation 508.8

Adverse Events

Guar Gum

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Control/Cellulose

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Guar Gum n=22 participants at risk 5 g of Guar gum fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Guar gum: Fibre supplement to be taken with each meal	Control/Cellulose n=19 participants at risk 5 g of Cellulose fibre supplement with meals three times a day (total daily 15 g) for 12 weeks Cellulose: Placebo. Fibre supplement to be taken with each meal
Gastrointestinal disorders Abdominal discomfort	50.0% 11/22 • Number of events 11 • 3 months	42.1% 8/19 • Number of events 8 • 3 months

Additional Information

Gary Frost

Imperial College London

Phone: 2075940959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place