Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

A High-protein Bedtime Snack to Control Morning Blood Glucose

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Dietary

Detailed Description

Fifteen patients with physician diagnosed type 2 diabetes (HbA1c 6.5-9%), between the ages of 30-80 years, and not on exogenous insulin therapy, will complete three, 3-day intervention periods (proof-of-concept randomized trial). Participants will consume a standardized diet for three days with either i) two hard-boiled eggs, ii) fruit yogurt; or iii) control no-bedtime snack, thirty minutes prior to bedtime. Fasting blood samples will be obtained on Day 4 in the morning after following each 3-day dietary intervention. Blood glucose will be monitored continuously across the intervention period using continuous glucose monitoring (CGM). CGM allows for the moment-to-moment changes in blood glucose to be examined for several days, allowing the unique opportunity to examine the glucose responses at different points of the day, including fasting hyperglycemia in the morning, nocturnal glucose, and postprandial glucose in response to meals. To our knowledge, CGM technology has never been used in a bedtime snacking study in type 2 diabetes.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • University of British Columbia, Okanagan.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Heart attack or stroke within last year
• Exogenous insulin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High protein no carbohydrate; 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; Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.
ACTIVE_COMPARATOR: High protein carbohydrate containing; 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; Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.
NO_INTERVENTION: Control no snack; No snack will be consumed prior to bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting Plasma glucose	Fasting Plasma glucose	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 h mean blood glucose	continuous blood glucose monitoring	Average of three days during each intervention
postprandial glucose	breakfast AUC	Average of three days during each intervention
Fasting insulin	Fasting plasma insulin	Average of three days during each intervention
Fasting homeostasis model assessment of insulin resistance (HOMA-IR)	Calculated by fasting plasma glucose and insulin	Day 4
Overnight blood glucose	Glucose assessed during sleep by continuous glucose monitoring	Average of three days during each intervention
Fasting continuous glucose monitoring glucose	15-minute average glucose assessed by CGM in the fasted state upon awakening	Average of the three days during each intervention

Collaborators and Investigators

• Sponsor: University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2017
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H17-01055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No