Trial Outcomes & Findings for Effects of an Apple Extract on Glycaemia: The GLU-Pomme Study (NCT NCT02940249)

NCT ID: NCT02940249

Last Updated: 2020-06-17

Results Overview

Primary outcome: Area over baseline t+0-30 min for plasma glucose

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

30 min following the test drink

Results posted on

2020-06-17

Participant Flow

Healthy participants were recruited from King's College London (KCL) and the general public in London and surrounding counties.

34 out of 64 screened were randomized. Of those not randomized, 8 did not meet inclusion criteria, 1 had a minor adverse event, and 21 declined to participate.

Participant milestones

Participant milestones
Measure	Doses of Apple Extract Randomised sequences of singled doses of 0, 0.9, 1.2 and 1.8 g apple extract consumed with a test meal. Participants first received intervention 1 on the morning of a study visit, followed by a washout period of at least 7 days, then intervention 2 followed by a 7 day washout period, then intervention 3 followed by a 7 day washout period, then intervention 4.
Overall Study STARTED	34
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Numbers analyzed in rows differ from overall as they are given for men, postmenopausal women, and premenopausal women separately.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=30 Participants All participants completing all study interventions
Age, Customized Males	30 years STANDARD_DEVIATION 12 • n=11 Participants • Numbers analyzed in rows differ from overall as they are given for men, postmenopausal women, and premenopausal women separately.
Age, Customized Premenopausal females	27 years STANDARD_DEVIATION 8 • n=13 Participants • Numbers analyzed in rows differ from overall as they are given for men, postmenopausal women, and premenopausal women separately.
Age, Customized Postmenopausal females	56 years STANDARD_DEVIATION 7 • n=6 Participants • Numbers analyzed in rows differ from overall as they are given for men, postmenopausal women, and premenopausal women separately.
Sex: Female, Male Female	19 Participants n=30 Participants
Sex: Female, Male Male	11 Participants n=30 Participants
Region of Enrollment United Kingdom	30 participants n=30 Participants
Fasting glucose	5.18 mmol/L STANDARD_DEVIATION 0.39 • n=30 Participants

PRIMARY outcome

Timeframe: 30 min following the test drink

Primary outcome: Area over baseline t+0-30 min for plasma glucose

Outcome measures

Outcome measures
Measure	1.8 g Apple Extract n=30 Participants High dose of polyphenol apple extract in a drink	1.2 g Apple Extract n=30 Participants Medium dose of polyphenol apple extract in a drink	0.9 g Apple Extract n=30 Participants Low dose of apple extract in a drink	0 g Apple Extract n=30 Participants Control in a drink matched for appearance and macronutrients
Postprandial Glycaemia	11.3 mmol/L*min Standard Error 1.2	15.2 mmol/L*min Standard Error 1.5	17.8 mmol/L*min Standard Error 1.6	27.1 mmol/L*min Standard Error 2.5

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial insulin concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial GIP concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial GLP-1 concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial C-peptide concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial NEFA concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial TAG concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial paracetamol concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min (1.5 g paracetamol will be added to all test drinks in a sub-group of participants).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink

Peak postprandial polyphenol metabolites concentrations (Cmax) t +0-30 min and change from baseline data and areas over baseline t+0-30 min and t+0-240 min.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 120, 240, 300 min following the test drink

Change in FMD after the consumption of test drink.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 60, 90, 120, 180, 240 min following the test drink

Change in augmentation index following the test drink.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 60, 90, 120, 180, 240 min following the test drink

Change in blood pressure following the test drink.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-4 h, 4-8 h, 8-24 h following the test drink

Change in urinary polyphenol metabolite concentration following the test drink.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0-4 h, 4-8 h, 8-24 h following the test drink

Change in urinary glucose concentration following the test drink.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Habitual dietary intake analysis

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Questionnaire to identify menstrual phase

Outcome measures

Outcome data not reported

Adverse Events

1.8 g Apple Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1.2 g Apple Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0.9 g Apple Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

0 g Apple Extract

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

Dr Wendy Hall

King's College London

Phone: 020 7836 5454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place