Measuring the Cardio-metabolic Response to Diet Quality M... | NCT04182867

NCT04182867

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dietary intervention	Other	Dietary modification (provision of diet).	Shift worker diet UK dietary guideline diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Acceptability of test diet	Likert scale questionnaire	3 night shifts, an average of 72 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
No travel arrangements outside UK within the period of data collection.
Not already participating in a clinical trial.
Able to give informed written consent.

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics