NCT03207269

Brief Summary

Approximately 3 million Canadians have type 2 diabetes, a condition where the blood sugar levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other complications. Patients with type 2 diabetes are often advised to consume a snack before bed in order to help control morning blood sugar levels. However, scientific evidence for this dietary approach is limited and there is no data to help elucidate what the ideal bedtime snack is. We hypothesize that a high protein, high fat snack with very little carbohydrate, will be an effective bedtime snack for lowering morning glucose without spiking glucose levels in the night. In this study we will determine if a bedtime snack that is high in protein and fat but low in carbohydrate can help improve morning glucose control in people with type 2 diabetes. This information will provide scientific evidence for the potential health benefits of strategically-timed high protein, high fat snack consumption in people with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

June 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

July 20, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

November 7, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

June 30, 2017

Last Update Submit

November 5, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Fasting Plasma glucose

    Fasting Plasma glucose

    Day 4

Secondary Outcomes (6)

  • 24 h mean blood glucose

    Average of three days during each intervention

  • postprandial glucose

    Average of three days during each intervention

  • Fasting insulin

    Average of three days during each intervention

  • Fasting homeostasis model assessment of insulin resistance (HOMA-IR)

    Day 4

  • Overnight blood glucose

    Average of three days during each intervention

  • +1 more secondary outcomes

Study Arms (3)

High protein no carbohydrate

EXPERIMENTAL

Dietary. Two eggs will be consumed 30 minutes prior to bedtime. Energy content of dinner will be reduced to account for the calories in the bedtime snack.

Other: Dietary

High protein carbohydrate containing

ACTIVE COMPARATOR

Dietary. A low-fat yogurt will be consumed 30 minutes prior to bedtime. Protein will be matched to the high protein bedtime snack condition. Energy content of dinner will be reduced to account for the calories in the bedtime snack.

Other: Dietary

Control no snack

NO INTERVENTION

No snack will be consumed prior to bed.

Interventions

DietaryOTHER

Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.

High protein carbohydrate containingHigh protein no carbohydrate

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed Type 2 Diabetes
  • HbA1c between 6.5 - 9.0%
  • No dietary restraints (lactose intolerance, dislike eggs, celiac disease)

You may not qualify if:

  • Heart attack or stroke within last year
  • Exogenous insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (1)

  • Abbie E, Francois ME, Chang CR, Barry JC, Little JP. A low-carbohydrate protein-rich bedtime snack to control fasting and nocturnal glucose in type 2 diabetes: A randomized trial. Clin Nutr. 2020 Dec;39(12):3601-3606. doi: 10.1016/j.clnu.2020.03.008. Epub 2020 Mar 13.

    PMID: 32204977DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

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

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 2, 2017

Study Start

July 20, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

November 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)