Trial Outcomes & Findings for Effect of Lactose on Blood Lipids (NCT NCT04924530)

Results Overview

Incremental area under the curve (iAUC) of plasma triglyceride concentrations from timepoints 0, 30, 60, 120, 180, 240, 300, 360 minutes

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

6 hours

Results posted on

2024-09-23

Participant Flow

2 dropouts

Participant milestones

Participant milestones
Measure	Sequence 1 Sucrose first, then Lactose, then Maltodextrin	Sequence 2 Sucrose first, then Maltodextrin, then Lactose	Sequence 3 Lactose first, then Sucrose, then Maltodextrin	Sequence 4 Lactose first, then Maltodextrin, then Sucrose	Sequence 5 Maltodextrin first, then Sucrose, then Lactose	Sequence 6 Maltodextrin first, then Lactose, then Sucrose
Period 1 STARTED	7	3	4	2	4	4
Period 1 COMPLETED	7	3	4	2	4	4
Period 1 NOT COMPLETED	0	0	0	0	0	0
Period 2 STARTED	7	3	4	2	4	4
Period 2 COMPLETED	7	3	4	2	4	4
Period 2 NOT COMPLETED	0	0	0	0	0	0
Period 3 STARTED	7	3	4	2	4	4
Period 3 COMPLETED	7	3	4	2	4	4
Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=24 Participants All participants completed all conditions/arms and hence are pooled for baseline measures
Age, Continuous	24 years STANDARD_DEVIATION 6 • n=24 Participants
Sex: Female, Male Female	12 Participants n=24 Participants
Sex: Female, Male Male	12 Participants n=24 Participants
Region of Enrollment United Kingdom	24 participants n=24 Participants
Height (m)	1.77 meters STANDARD_DEVIATION 0.11 • n=24 Participants
Body mass (kg)	72.7 kg STANDARD_DEVIATION 12.9 • n=24 Participants
Body mass index (kg/m^2)	23.3 kg/m2 STANDARD_DEVIATION 2.2 • n=24 Participants
Body fat (percentage of mass)	27 % STANDARD_DEVIATION 9 • n=24 Participants
Fat mass (kg)	19.4 kg STANDARD_DEVIATION 7.3 • n=24 Participants
Fat-free mass (kg)	53.8 kg STANDARD_DEVIATION 12.0 • n=24 Participants

PRIMARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma triglyceride concentrations from timepoints 0, 30, 60, 120, 180, 240, 300, 360 minutes

Outcome measures

Outcome measures
Measure	Maltodextrin n=24 Participants Glucose polymer; a common sugar substitute Maltodextrin: Co-ingestion of maltodextrin with a high fat meal	Sucrose n=24 Participants Fructose-glucose disaccharide Sucrose: Co-ingestion of sucrose with a high fat meal	Lactose n=24 Participants Galactose-glucose disaccharide Lactose: Co-ingestion of lactose with a high fat meal
Postprandial Changes in Plasma Triglyceride Concentrations	51 mmol/L x 360 min Standard Deviation 68	90 mmol/L x 360 min Standard Deviation 95	98 mmol/L x 360 min Standard Deviation 88

SECONDARY outcome

Timeframe: 6 hours

Time course for synthesis of fatty acids from non-lipid precursors using stable isotope methodology

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Time course for whole-body dietary fatty acid oxidation using stable isotope methodology

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma insulin concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma glucose concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma galactose concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma fructose concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma VLDL-rich triglyceride \[Svedberg flotation rate (Sf): 20-400\] concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma chylomicron-rich triglyceride (Sf: \>400) concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma lactate concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma non-esterified fatty acid concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma beta-hydroxybutyrate concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 hours

Incremental area under the curve (iAUC) of plasma uric acid concentrations

Outcome measures

Outcome data not reported

Adverse Events

Maltodextrin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sucrose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lactose

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

Professor Javier Gonzalez

University of Bath

Phone: 01225 38

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place