Status:
COMPLETED
STARchy Staples: a Randomised Controlled Trial on Cardiometabolic Health
Lead Sponsor:
King's College London
Collaborating Sponsors:
Alliance for Potato Research and Education
Maastricht University
Conditions:
Cardiometabolic Health
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
An investigation into habitual potato consumption (mashed, boiled, baked) on sleep quality and chronic glycaemic control, established risk factors for cardiometabolic diseases, versus habitual consump...
Detailed Description
In the last few years, researchers have undergone efforts to conduct well-controlled trials to investigate the cardiometabolic health effect of consuming potatoes as part of a healthy diet. None to ou...
Eligibility Criteria
Inclusion
- Self-reported healthy adults
- Aged 40-80 years old
- Intake of ≤4 portions of fruits and vegetables (excluding potatoes) per day
- Low sleep quality index of \>5 (Pittsburgh sleep quality index).
Exclusion
- Shift workers and those with multiple jobs or carers who are required to wake through the night
- Unwilling to refrain from dietary supplements
- Unwilling to follow protocol and/or give informed consent
- Diagnosed with Cardiovascular Disease (CVD), Type 2 Diabetes, Celiac disease, Insomnia, Sleep apnoea
- Presence of gastrointestinal disorder
- Users of drugs that are likely to alter gastrointestinal motility or nutrient absorption
- History of substance abuse or alcoholism
- Currently pregnant, planning pregnancy, breastfeeding, or having had a baby 12 months prior
- Weight change of \>3kg in the preceding 2 months
- BMI \<18.5kg/m2 or \> 35kg/m2,
- Current smokers, or individuals who quit smoking in the last 6-months
- Frequently consume wholemeal products (1-2 times per day, in the short screening FFQ)
- Never consumed refined starchy staples, such as white pasta or rice (rarely or never, in the short screening FFQ)
- High potato consumption (4-6 times per week, in the short screening FFQ)
- High risk of obstructive sleep apnoea (answer yes to \>3 questions, in STOP-Bang questionnaire)
- Vegetarian, Vegan, or pescatarian dietary preferences.
- Diagnosed with mental health disorders, and/or on medicine for their mental health (antipsychotics, antidepressants, beta-blockers)
- Chronic user of antihistamines
- Fasting glucose \>7mmol/l (finger prick test at baseline clinic)
- Is taking weight loss, or glucose regulating medications.
- Has been unstable on blood pressure lowering medications for at least 3-months prior to enrollment.
Key Trial Info
Start Date :
September 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT05994313
Start Date
September 9 2023
End Date
May 1 2025
Last Update
September 16 2025
Active Locations (1)
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1
Department of Nutritional Sciences, Franklin Wilkins Building, Waterloo campus.
Lambeth, London, United Kingdom, SE1 9NH