Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05513404 |
Other study ID # |
2022_01/ROW-Honeyberry |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 15, 2022 |
Est. completion date |
March 31, 2024 |
Study information
Verified date |
May 2024 |
Source |
University of Aberdeen |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine if new varieties of fruits grown in Scotland which
can adapt better to climate change namely, honeyberries and cherries, have the same health
benefits as established fruits such as raspberries. To do this we will investigate the
effects of consuming honeyberries, cherries, and raspberries on short term changes in blood
glucose, and on short term memory.
Description:
As humans spend most of their day in a postprandial state, it is imperative that the
metabolic effects of diets are well understood if the incidence of chronic disorders such as
type 2 diabetes (T2D) is to be controlled. Current estimates place global incidence of
diabetes at 537 million, and this number is predicted to rise a further 45% by 2045. T2D is
linked to increased risk of developing other chronic health conditions including
cardiovascular disease (CVD) and dementia.
Controlling the acute glycaemic response and avoiding hyperglycaemia is essential for
reducing diabetic risk. In addition, acute hyperglycaemia may provoke metabolic reactions
increasing CVD risk and lower episodic memory even in non-diabetic individuals. Diet has an
important role to play, and modern Western diets typically have high glycaemic loads due to
excessive refined and total carbohydrate contents. As a result, the average blood glucose
concentration of individuals has increased over the past three decades.
Polyphenolic constituents of foods may help to delay starch and disaccharide digestion and
glucose absorption following a carbohydrate-containing meal or beverage. In vitro studies
suggest that some polyphenols found in fruits are effective inhibitors of digestive enzymes,
α-amylases and α-glucosidases and inhibit the action of intestinal glucose transporters.
There is only a small amount of information available from human studies however, randomized
controlled trials (RCTs) have shown that fruits reduced postprandial glucose concentrations
following consumption of either starch, glucose or sucrose loads. Strategies to control
chronic postprandial hyperglycaemia through increased consumption of such polyphenol rich
foods would strengthen efforts to reduce the risk of developing T2D in the general
population.
The aim of this study is to test the health benefits of new climate resistant fruit high in
polyphenols grown in Scotland with and an existing crop already established in the fruit
market. The hypothesis is that consumption of honeyberries and cherries grown in Scotland is
as effective as raspberries in reducing the postprandial glycemic response in normal weight
/overweight, healthy men, and post-menopausal women. With a secondary objective looking at
the effects of these fruits on cognitive function.
This is a randomized cross over study and will aim to recruit 28 normal to overweight (BMI ≥
18.5 and < 39.9), men or post-menopausal women (post-menopausal defined as not having had a
period for over a year), aged ≥40 and ≤ 70 years who will attend four study sessions. The
first study session will be an oral glucose tolerance test (OGTT) and the remaining three
will be identical in all respects except for the addition of the fruit. Consecutive blood
samples will be collected in all 4 study sessions which will be used to measure glucose,
insulin, C-peptide, incretins, and lipids. Cognitive function the secondary outcome will be
measured using a series of memory tests.