Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT05513404
Brief 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.
Detailed 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.
Study:
NCT05513404
Study Brief:
Protocol Section:
NCT05513404