NCT04748575

Brief Summary

Type 2 Diabetes Mellitus is a chronic disease that results in hyperglycaemia. This study aimed to identify whether the anthocyanins contained in acai berries can mitigate postprandial glycaemia in healthy adults when consumed in conjunction with carbohydrate. Study design was double blind randomised crossover with glycaemic levels assessed via capillary blood samples taken at baseline and over a 2 hour post-prandial period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 4, 2021

Last Update Submit

February 9, 2021

Conditions

Keywords

Acai (Euterpe oleracea), acute

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Finger capillary sample collected by micro cuvette (Glucose 201, HemoCue, UK) and analysed electronically (HemoCue 201+, HemoCue,UK).

    Baseline to 120 minutes after intervention.

Study Arms (2)

Acai smoothie consumption

EXPERIMENTAL

Participants (n=5) in this arm were randomly allocated to consume the acai smoothie at the first intervention. After a 7 day wash-out period, the participants consumed the placebo smoothie.

Dietary Supplement: Acai smoothie

Placebo smoothie consumption

EXPERIMENTAL

Participants (n=5) in this arm were randomly allocated to consume the placebo smoothie at the first intervention. After a 7 day wash-out period, the participants consumed the acai smoothie.

Dietary Supplement: Placebo smoothie

Interventions

Acai smoothieDIETARY_SUPPLEMENT

Smoothie containing 150g acai pulp

Acai smoothie consumption
Placebo smoothieDIETARY_SUPPLEMENT

Control smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie.

Placebo smoothie consumption

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 18.5 - 24.9 kg/m2.

You may not qualify if:

  • Known allergy to acai/berries or lactose.
  • Pregnant or lactating.
  • Alcohol/drug dependency.
  • Smoking.
  • Currently on an energy-restriction diet or have had a body weight change \>10% in last 2 months.
  • Eating disorders.
  • Diagnosed with diabetes or another chronic condition.
  • Taking chronic medication.
  • Allergy to any of materials used in, or an unsurmountable fear of, the finger-prick procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Marys University

London, TW1 4SX, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Smoothies were prepared by the Laboratory Technician and blinded from the participant and investigator. Acai and placebo smoothies were matched nutritionally including for carbohydrate, total sugars, protein, fat and fibre. Additionally, the smoothies were matched for colour, taste and temperature and were served in opaque containers.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomised double-blind crossover
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 10, 2021

Study Start

November 5, 2020

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations