Measuring the Cardio-metabolic Response to Diet Quality Modification During Night Work.

NCT04182867 | Terminated

• 1 other identifier: Drum2019RG
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to investigate the acute impact of diet quality modification during night work on 24-hr glucose variability (GV) and heart rate variability (HRV) in healthy free-living employees.

Conditions

Shift Work

Outcome Measures

Primary Outcomes (4)

• Blood glucose variability (mean amplitude of glycaemic excursions)

  24-hr blood glucose variability measured by continuous glucose monitor

  3 night shifts, an average of 72 hours

• Blood glucose variability (coefficient variation)

  24-hr blood glucose variability measured by continuous glucose monitor

  3 night shifts, an average of 72 hours

• Blood glucose variability (time in range)

  24-hr blood glucose variability measured by continuous glucose monitor

  3 night shifts, an average of 72 hours

• Heart rate variability

  24-hr heart rate variability measured by heart rate monitor

  3 night shifts, an average of 72 hours

Secondary Outcomes (1)

• Acceptability of test diet

  3 night shifts, an average of 72 hours

Study Arms (2)

UK dietary guideline diet

EXPERIMENTAL

A 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). The experimental diet will meet UK dietary guidelines for fiber, salt, sugar, saturated fat, fruit and vegetable intake. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant. The diet will be consumed across 3 consecutive night shifts.

Other: Dietary intervention

Shift worker diet

OTHER

A 4-day diet (food and beverage provision for 3 meals and 2 snacks) will be provided along with an eating plan (time of each meal / snack). Typical 'shift diet' based on previous research investigating what UK night workers eat. The 'shift diet' will contain \~15% energy from added sugar, 15g fiber, 2.5 portions fruit/vegetable, no whole grains. Required energy intake (calories) for each day to maintain their current body weight. Energy (calorie) requirements for each participant will be calculated from age, sex and weight of the participant.The diet will be consumed across 3 consecutive night shifts.

Other: Dietary intervention

Interventions

Dietary intervention OTHER

Dietary modification (provision of diet).

Shift worker diet; UK dietary guideline diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current night shift worker (defined as a period of work between 11pm and 6am) working regular blocks of 3 night shifts.
• Body mass index between 18.5 and 35 kg/m2.
• Weight stable (no weight change by more than 3 kg in the last 2 months).
• Not a regular smoker (1 or more cigarettes per day) and would be willing not to smoke for the duration of the study.
• Not pregnant or breastfeeding.
• Not diagnosed with heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer.
• Not currently taking medication to stabilize blood glucose (e.g. acarbose, metformin or sulfonylureas).
• Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
• Do not take medication for blood pressure e.g. diuretics, (beta-blockers, Ca-channel, ACE inhibitors, Angiotensin Receptor blockers)
• Do not have diagnosed hypertension (high blood pressure, systolic blood pressure that is higher than 180 mmHg and or diastolic blood pressure that is higher than 110 mmHg).
• Not diagnosed with arterial fibrillation or any other condition that affects heart rate (e.g. arrhythmia).
• No food intolerance, allergies, hypersensitivity or follow any dietary restrictions (e.g. gluten intolerance, coeliac, lactose intolerance, vegan or vegetarian) that will prevent the ability to follow the test diets.
• Do not have a history substance abuse, or current high alcohol intake (\>28 units/week for males and \>21 units/week for females).
• Able to understand the information sheet and willing to comply with study protocol and able to follow dietary instructions before and during the study.
• Ability to prepare basic meals from ingredients provided.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Life Course Sciences

London, SE1 9NH, United Kingdom

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: May 28, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)