NCT05012046

Brief Summary

The purpose of this study is to determine the effects of 100% orange juice on short-term food intake (FI), satiety, post-prandial glycemia and mood in healthy adults. We hypothesize that the consumption of 100% orange juice in the pre-meal environment will improve satiety signals and mood, and suppress FI through its effect on post-prandial glycemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable healthy

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

First Submitted

Initial submission to the registry

August 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

August 11, 2021

Last Update Submit

March 2, 2023

Conditions

HealthyAdultGlycemic ResponseAppetite

Keywords

Food intakeAppetiteBlood glucoseGlycemic responseOrange juiceAdults

Outcome Measures

Primary Outcomes (3)

  • Change from baseline glycemic response (acute phase)

    Blood glucose (mmol/L). Three drops of blood from the finger will be collected at each time point using a single-use, auto-disabling lancet device and sodium fluoride/potassium oxalate capillary blood collection tubes. Blood glucose will be measured using a YSI 2900D Biochemistry Analyzer (YSI Inc., Yellow Springs, OH).

    Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption

  • Rest-of-day blood glucose concentrations

    Blood glucose (mmol/L). Rest-of-day blood glucose concentrations will be determined using a Dexcom G6 CGM system.

    Continuous measurements for 24 hours post-treatment consumption

  • Ad libitum food intake

    Lunch pizza meal. Food intake will be determined by weighing the meal before and after serving. The net weight of the test meal will be converted to calories.

    At 60 minutes post-treatment consumption

Secondary Outcomes (4)

  • Change from baseline subjective appetite

    Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption

  • Change from baseline subjective emotions and mood

    Collected at baseline (0 minutes), 15 minutes, 30 minutes, 45 minutes, and 60 minutes post-treatment consumption

  • Rest-of-the-day food intake

    For the rest of the day following test session completion (1 day)

  • Rest-of-the-day physical activity

    For the rest of the day following test session completion (1 day)

Study Arms (3)

Orange juice

EXPERIMENTAL

Treatment beverage

Other: Orange juice

Orange flavoured drink

EXPERIMENTAL

Treatment beverage

Other: Orange flavoured drink

Water

EXPERIMENTAL

Treatment beverage

Other: Water

Interventions

Orange juiceOTHER

Matched for volume (240 mL/ 8 oz) of other test beverages. 100% orange juice.

Orange juice
Orange flavoured drinkOTHER

Matched for volume (240 mL/ 8 oz) of other test beverages. Orange flavoured drink

Orange flavoured drink
WaterOTHER

Matched for volume (240 mL/ 8 oz) of other test beverages. Water control

Water

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-45 years;
  • within the healthy body mass index (BMI) range for adults of 18.5-24.9 kg/m2.

You may not qualify if:

  • individuals who are dieting;
  • restrained eaters;
  • breakfast skippers;
  • those who dislike breakfast or lunch treatment foods;
  • those taking medication;
  • individuals with any metabolic disorders or significant weight fluctuations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Urban Innovation (CUI-109), School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Nick Bellissimo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 19, 2021

Study Start

October 1, 2021

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)