Trial Outcomes & Findings for Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort (NCT NCT05364437)

Results Overview

Changes in stool short-chain fatty acids production from baseline after each intervention (cellulose control and dietary fibre supplement) between mothers and daughters

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

14 days

Results posted on

2025-04-29

Participant Flow

Volunteers recruited by study advert Study start date 2022-10-04 Study end date 2023-04-04

The intervention is dietary fibres so wash out is necessary to allow the physiological measurements to return to baseline level.

Participant milestones

Participant milestones
Measure	Mothers Dietary Fibres Supplement First Then Cellulose Control Dietary fibre mix comprising of inulin, pectin and oat beta-glucan. The mix comes in a powdered form which can be added to participants' food. Four mothers took dietary fibre mix first. Dietary Fibres Mix: The Fibre Mix, which comprises of a mix of dietary fibres (inulin, pectin and oat beta-glucan) will need to be taken by participants twice daily for 2 weeks with their usual food. This group of mothers took dietary fibre mix first and then they took the cellulose control after the wash-out period.	Mothers Cellulose Control First Then Dietary Fibres Supplement Control comprising of cellulose which will come in a powdered form that can be added to participants' food. Four mothers took the cellulose control first and then they took the dietary fibre mix supplement after the wash out period. Control: The control, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.	Daughters Dietary Fibres Supplement First Then Cellulose Control Dietary fibre mix consisted of inulin, pectin and oat beta-glucan which the volunteers were able to add to their foods. The control consisted of cellulose which the participants were able to add to their foods. In this arm, the daughters took the dietary fibre supplement first and then they took the cellulose control following the wash-out period. Three daughters took the dietary fibre supplement first.	Daughters Cellulose First Then Dietary Fibre Supplement. The control consisted of cellulose which the volunteers added to their usual foods. This group of daughters took cellulose control first and then they took the dietary fibre mix after the wash-out period. In this group, five daughters took the cellulose control first.
Study Period 1 STARTED	4	4	3	5
Study Period 1 COMPLETED	4	4	3	5
Study Period 1 NOT COMPLETED	0	0	0	0
Washout STARTED	4	4	3	5
Washout COMPLETED	4	4	3	5
Washout NOT COMPLETED	0	0	0	0
Study Period 2 STARTED	4	4	3	5
Study Period 2 COMPLETED	4	4	3	5
Study Period 2 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of the Effects of Dietary Fibres on the Gut Microbiome in a Transgenerational Cohort

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 14 days

Population: Mothers and daughters data after taking the dietary fibre supplement for 14 days

Changes in stool short-chain fatty acids production from baseline after each intervention (cellulose control and dietary fibre supplement) between mothers and daughters

Outcome measures

Outcome measures
Measure	Mothers Dietary Fibre Supplement n=8 Participants Mothers took the dietary fibre supplement for 14 days.	Mothers Cellulose Control n=8 Participants Mothers took the cellulose control for 14 days.	Daughters Dietary Fibre Supplement n=8 Participants Daughters took the dietary fibre supplement for 14 days	Daughters Cellulose Control n=8 Participants Daughters took the cellulose control for 14 days.
Stool Short-chain Fatty Acids Production Following Each Intervention Between Mothers and Daughters	50 umol/g Standard Error 0.176	26 umol/g Standard Error 0.709	41.7 umol/g Standard Error 0.106	47.8 umol/g Standard Error 0.126

SECONDARY outcome

Timeframe: 14 days

Alpha diversity (a measure of the gut microbiota composition) was compared between generations after taking each dietary supplement for 14 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Changes in urine metabolites types and levels after each generation took both supplements

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Changes in stool metabolites types and levels between mothers and daughters after taking each supplement. Comparisons done: mothers on dietary fibres supplement versus daughters on dietary fibre supplement and mothers on cellulose control versus daughters on cellulose control

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Fasted blood glucose levels in mothers and daughters after each generation took each supplement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 240 minutes

Postprandial blood glucose levels comparison between mothers and daughters after each generation took each supplement for 14 days. The data is presented as incremental area under the curve.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Fasted blood insulin levels comparison between mothers and daughters after each generation took the dietary supplements for 14 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Postprandial blood insulin levels comparison between mothers and daughters after each generation took the supplements (dietary fibre and cellulose) for 14 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Fasted gut hormones levels in mothers after they took the dietary fibre supplement compared to fasted gut hormones in daughters after they took the dietary fibre supplements. Fasted gut hormones levels in mothers after they took the cellulose control compared to fasted gut hormones in daughters after they took the cellulose control.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Postprandial gut hormones levels were compared in mothers after they took the dietary fibre supplements against postprandial gut hormone levels in daughters after they took the dietary fibre supplement. Postprandial gut hormones levels were compared in mothers after they took the cellulose control against postprandial gut hormone levels in daughters after they took the cellulose control.

Outcome measures

Outcome data not reported

Adverse Events

Dietary Fibre Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cellulose Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gary Frost

Imperial College London

Phone: 07872850308

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Mothers n=8 Participants Parent to the Daughter in the placebo group Dietary Fibres Mix: The Fibre Mix, which comprises of a mix of dietary fibres (inulin, pectin and oat beta-glucan) will need to be taken by participants twice daily for 2 weeks with their usual food. Placebo: The placebo, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.	Daughter n=8 Participants Child of Mother Dietary Fibres Mix: The Fibre Mix, which comprises of a mix of dietary fibres (inulin, pectin and oat beta-glucan) will need to be taken by participants twice daily for 2 weeks with their usual food. Placebo: The placebo, which comprises of cellulose will need to be taken by participants twice daily for 2 weeks with their usual food.	Total n=16 Participants Total of all reporting groups
Age, Categorical participants · <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical participants · Between 18 and 65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical participants · >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	57.6 years STANDARD_DEVIATION 2.1 • n=5 Participants	26.7 years STANDARD_DEVIATION 1.9 • n=7 Participants	41.6 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants
Fasted HbA1C	37.75 mmol/l STANDARD_DEVIATION 1.1 • n=5 Participants	33.38 mmol/l STANDARD_DEVIATION 0.93 • n=7 Participants	35.56 mmol/l STANDARD_DEVIATION 0.89 • n=5 Participants