Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes

NCT ID: NCT03207269

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2018-08-31

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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Dietary

Intervention Type: OTHER

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

Control no snack

No snack will be consumed prior to bed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Little

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of British Columbia, Okanagan.

Kelowna, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32204977 (View on PubMed)

Other Identifiers

H17-01055

Identifier Type: -

Identifier Source: org_study_id