NCT04659850

Brief Summary

A number of processed foods particularly those high in protein and based on whey protein are high in advanced glycation end products (AGEs). AGEs are the result of a chemical reaction between mainly sugar and protein when they are heated together (known as the Maillard reaction). Whey protein is routinely derived via high temperature processing methods which produce AGEs. AGEs are absorbed during digestion and high circulating concentrations of AGEs are associated with adverse health effects such as dementia and the metabolic syndrome. In this study we aim to firstly ascertain the habitual level of AGE intake in the diet via a dietary questionnaire and equate this to both metabolic health and cognition at baseline. Volunteers will then be given a milkshake with either a high or low AGE content on either a high or low fat background. AGEs are usually ingested as part of a processed food diet which can be high in fat and it is necessary to separate the effects of these two food types. We will test these effects in a young and older group of volunteers with low and higher levels of circulating AGEs respectively. Circulating levels of hormones, glucose and lipids in the blood will be measured as indicators of metabolic health. Cognitive tests will be carried out to assess the impact of AGEs on episodic memory.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

4 years

First QC Date

November 24, 2020

Last Update Submit

December 2, 2020

Conditions

No Conditions

Outcome Measures

Primary Outcomes (1)

  • Impact of Advanced Glycation End Products on Metabolism and Cognition

    Habitual AGE intake, determined from dietary questionnaires, specifically designed for this purpose, taken at the start of the study, will be correlated with levels of circulating AGEs and outcomes such as inflammatory markers and expression of genes associated with susceptibility to metabolic disease and acute response to dietary challenge will be measured.

    Four weeks per participant

Study Arms (2)

Group 1

OTHER

Group 1 participants in the young 18 - 30 age group

Other: low fat, low AGE milkshakeOther: low fat, high AGE milkshakeOther: high fat, low AGEOther: high fat, high AGE milkshake

Group 2

OTHER

Group 2 participants in the older 55 - 75 age group

Other: low fat, low AGE milkshakeOther: low fat, high AGE milkshakeOther: high fat, low AGEOther: high fat, high AGE milkshake

Interventions

low fat, low AGE milkshakeOTHER

low fat, low AGE milkshake given after an overnight fast

Group 1Group 2
low fat, high AGE milkshakeOTHER

low fat, high AGE milkshake given after an overnight fast

Group 1Group 2
high fat, low AGEOTHER

high fat, low AGE milkshake given after an overnight fast

Group 1Group 2
high fat, high AGE milkshakeOTHER

high fat, high AGE milkshake given after an overnight fast

Group 1Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heathy
  • Sedentary

You may not qualify if:

  • diagnosed type 2 diabetes,
  • CVD
  • history of neurological abnormalities
  • current psycho-active medication
  • current anti-inflammatory medication
  • Current glucose lowering medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, Scotland, AB252ZD, United Kingdom

RECRUITING

MeSH Terms

Interventions

Diet, Fat-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Fiona Campbell, PHD

    UoA Rowett Institute of Nutrition and Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Campbell, PHD

CONTACT

01224438617fiona.campbell@abdn.ac.uk

Christine Grant, HNC Biology

CONTACT

01224438708christine.grant@abdn.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Dietary Challenge
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 9, 2020

Study Start

November 1, 2017

Primary Completion

November 1, 2021

Study Completion

March 1, 2022

Last Updated

December 9, 2020

Record last verified: 2020-12

Locations

GB(1)