NCT02933424

Brief Summary

The objective of this study is to compare the effects of adding three plant-based proteins (rice, oats and pea proteins) to a breakfast beverage on the glycemic response, appetite and subsequent food intake of healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

September 27, 2016

Last Update Submit

January 24, 2018

Conditions

Pre-diabetesObesity

Outcome Measures

Primary Outcomes (5)

  • Change in blood glucose

    Blood glucose measured up to 180 minutes

    Up to 180 minutes

  • Change in blood insulin

    Blood insulin measured up to 180 minutes

    Up to 180 minutes

  • Change in gut hormones

    Blood gut hormones measured up to 180 minutes

    Up to 180 minutes

  • Change in body weight

    Body weight measured with a Bio-electrical impedance scale

    At baseline

  • Change in body composition

    Fat% measured with a Bio-electrical impedance scale

    At baseline

Secondary Outcomes (3)

  • Change in subjective appetite ratings

    Up to 180 minutes

  • Change in plasma amino acid

    Up to 180 minutes

  • Meal challenge

    At 180 minutes

Study Arms (4)

Control beverage with no protein powder

NO INTERVENTION

Standard breakfast drink with no protein powder added

Beverage with Rice protein powder 25 grams

EXPERIMENTAL

Standard breakfast drink with 25 grams of rice protein powder.

Dietary Supplement: Protein Powder

Beverage with Pea protein powder 25 grams

EXPERIMENTAL

Standard breakfast drink with 25 grams of pea protein powder.

Dietary Supplement: Protein Powder

Beverage with Oats protein powder 25 grams

EXPERIMENTAL

Standard breakfast drink with 25 grams of Oats protein powder.

Dietary Supplement: Protein Powder

Interventions

Protein PowderDIETARY_SUPPLEMENT
Beverage with Oats protein powder 25 gramsBeverage with Pea protein powder 25 gramsBeverage with Rice protein powder 25 grams

Eligibility Criteria

Age21 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • BMI 18.5-24.9kgm-2
  • eating all meals (5 days/week)

You may not qualify if:

  • major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
  • have gout
  • have food allergies
  • are taking insulin or drugs known to affect metabolism, appetite and body fat distribution,
  • have weight change of \>5kg in the past 3 months
  • have major medical or surgical event requiring hospitalisation within the preceding three months
  • are on a weight loss regime, and presence of disease or drugs which influence digestion and absorption of nutrients
  • smokers,
  • individuals who take part in sports at competitive/endurance levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, Singapore

Location

Related Publications (1)

  • Tan SY, Siow PC, Peh E, Henry CJ. Influence of rice, pea and oat proteins in attenuating glycemic response of sugar-sweetened beverages. Eur J Nutr. 2018 Dec;57(8):2795-2803. doi: 10.1007/s00394-017-1547-3. Epub 2017 Sep 30.

    PMID: 28965176DERIVED

MeSH Terms

Conditions

Glucose IntoleranceObesity

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2016

First Posted

October 14, 2016

Study Start

September 1, 2016

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

SG(1)