NCT03369145: OVEREAT

High-fat Overfeeding, Hepatokines and Appetite Regulation

Completed NA Last updated 18 February 2019

What this trial tests

NA trial testing High-fat diet in Insulin Resistance in 12 participants. Completed in 31 July 2018.

Timeline

11 December 2017

Primary endpoint
31 July 2018

31 July 2018

Quick facts

Lead sponsor	Loughborough University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	11 December 2017
Primary completion	31 July 2018
Estimated completion	31 July 2018
Sites	2 locations across United Kingdom

Drugs / interventions tested

• High-fat diet

Conditions studied

• Insulin Resistance — all drugs for Insulin Resistance →
• Type2 Diabetes Mellitus — all drugs for Type2 Diabetes Mellitus →
• Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →
• Obesity — all drugs for Obesity →

Sponsor

Loughborough University

Who can join

Adults 18 to 40, male only, with Insulin Resistance or Type2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The present study will investigate the effect of high-fat overfeeding on a group of liver-secreted proteins linked to worsened blood sugar control, as well as proteins involved in appetite control. Participants will consume both a high-fat diet, consisting of 50% extra calories above their daily required intake, and a control diet, consisting of their normal 'habitual' diet, with each diet lasting seven days. The diets will be undertaken in a randomised order, with a period of three weeks separating the two diets. Blood samples will be taken before and after each diet to measure blood sugar control. Further blood samples will also be taken 24 hours and 72 hours into each diet to see how levels of the liver and appetite-regulating proteins change over the course of the seven days.

It is expected that blood sugar control will be worsened by the high-fat diet and this will be accompanied by increases in levels of the liver-secreted proteins and an impaired release of the appetite-regulating proteins into the blood.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Acute Hyperenergetic, High-Fat Feeding Increases Circulating FGF21, LECT2, and Fetuin-A in Healthy Men.
   Willis SA, Sargeant JA, Yates T, Takamura T, et al · · 2020 · cited 26× · PMID 31919514 · DOI 10.1093/jn/nxz333
2. Influence of Short-Term Hyperenergetic, High-Fat Feeding on Appetite, Appetite-Related Hormones, and Food Reward in Healthy Men.
   Thackray AE, Willis SA, Clayton DJ, Broom DR, et al · · 2020 · cited 4× · PMID 32872401 · DOI 10.3390/nu12092635