STARchy Staples: a Randomised Controlled Trial on Cardiometabolic Health

NCT05994313 | Completed

• 1 other identifier: RCT-DNS-SS-2023
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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 consumptions of non-nutrient-dense starchy staples (white rice, pasta, and couscous).

Conditions

Cardiometabolic Health

Keywords

Sleep efficiency; Glycemic control; Flow mediated dilation

Outcome Measures

Primary Outcomes (2)

• Change in 7-day sleep efficiency

  Differences in % sleep efficiency at endline vs baseline. Sleep efficiency % is described as the total time spent asleep/ total time spent in bed x 100.

  Pre- and post-intervention: 12 weeks

• Change in 12-day nocturnal mean glucose

  Differences in mean nocturnal glucose, measured using a Freestyle Libre 3 continuous glucose monitor.

  Pre- and post-intervention: 12 weeks

Secondary Outcomes (33)

• Change in mean nocturnal AUC

  Pre- and post-intervention: 12 weeks

• Difference in nocturnal TIR

  Pre- and post-intervention: 12 weeks

• Change in the nocturnal CV%

  Pre- and post-intervention: 12 weeks

• Change in nocturnal MAGE

  Pre- and post-intervention: 12 weeks

• Change in nocturnal MODD

  Pre- and post-intervention: 12 weeks

Study Arms (2)

Habitual potato consumption

EXPERIMENTAL

At least 230g of white potatoes, including fresh and frozen, baked, boiled, and mashed potatoes, will be consumed in the evening meal, in replacement of non-nutrient-dense starchy staples, for 12 weeks.

Dietary Supplement: Habitual potato consumption

Habitual non-nutrient-dense staple consumption

ACTIVE COMPARATOR

Isocaloric amounts of non-nutrient-dense starchy staples, such as white rice, white pasta, and white couscous, will be consumed in the evening meal for 12 weeks.

Dietary Supplement: Habitual non-nutrient-dense staple consumption

Interventions

Habitual potato consumption DIETARY_SUPPLEMENT

Potatoes are to be consumed in the evening meal, every evening for 12-weeks.

Habitual potato consumption

Habitual non-nutrient-dense staple consumption DIETARY_SUPPLEMENT

White rice, white pasta or white couscous are to be consumed in the evening meal, every evening for 12-weeks.

Habitual non-nutrient-dense staple consumption

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College London: lead
• Alliance for Potato Research and Education: collaborator
• Maastricht University: collaborator

Study Sites (1)

Department of Nutritional Sciences, Franklin Wilkins Building, Waterloo campus.

Lambeth, London, SE1 9NH, United Kingdom

Location

Related Publications (6)

• Robertson TM, Alzaabi AZ, Robertson MD, Fielding BA. Starchy Carbohydrates in a Healthy Diet: The Role of the Humble Potato. Nutrients. 2018 Nov 14;10(11):1764. doi: 10.3390/nu10111764.

  PMID: 30441846 BACKGROUND

• McGill CR, Kurilich AC, Davignon J. The role of potatoes and potato components in cardiometabolic health: a review. Ann Med. 2013 Nov;45(7):467-73. doi: 10.3109/07853890.2013.813633. Epub 2013 Jul 15.

  PMID: 23855880 BACKGROUND

• Stone MS, Martin BR, Weaver CM. Short-Term RCT of Increased Dietary Potassium from Potato or Potassium Gluconate: Effect on Blood Pressure, Microcirculation, and Potassium and Sodium Retention in Pre-Hypertensive-to-Hypertensive Adults. Nutrients. 2021 May 11;13(5):1610. doi: 10.3390/nu13051610.

  PMID: 34064968 BACKGROUND

• Johnston EA, Petersen KS, Kris-Etherton PM. Daily intake of non-fried potato does not affect markers of glycaemia and is associated with better diet quality compared with refined grains: a randomised, crossover study in healthy adults. Br J Nutr. 2020 May 14;123(9):1032-1042. doi: 10.1017/S0007114520000252. Epub 2020 Jan 22.

  PMID: 31964428 BACKGROUND

• Macdonald-Clarke CJ, Martin BR, McCabe LD, McCabe GP, Lachcik PJ, Wastney M, Weaver CM. Bioavailability of potassium from potatoes and potassium gluconate: a randomized dose response trial. Am J Clin Nutr. 2016 Aug;104(2):346-53. doi: 10.3945/ajcn.115.127225. Epub 2016 Jul 13.

  PMID: 27413123 BACKGROUND

• D'Elia L, Masulli M, Cappuccio FP, Zarrella AF, Strazzullo P, Galletti F. Dietary Potassium Intake and Risk of Diabetes: A Systematic Review and Meta-Analysis of Prospective Studies. Nutrients. 2022 Nov 12;14(22):4785. doi: 10.3390/nu14224785.

  PMID: 36432472 BACKGROUND

Study Officials

• Wendy Hall, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to whether they are receiving the intervention or control, but it is not possible to blind them to the food itself. The researcher conducting the statistical analysis will be blinded prior to analysis, using a second set of unique study ID codes.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 12-week Randomised controlled trial

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 16, 2023
• Study Start: September 9, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Protocol, SAP and ICF have been uploaded on 01/09/2025. Analytic code will be available from September 2026 to September 2036.
• Access Criteria: Please email the project PI, Professor Wendy Hall. Contact details are available in the contacts section.

Locations

GB (1)