Allulose and monk fruit study
ALLULOSE AND MONK FRUIT STUDY
Next-Generation Sweetener: Investigating Insulin Sensitivity and Metabolic Outcomes of the Novel Rare Sugar Allulose in Overweight and Obese Adults — A 3-Week Double-Blind Randomized Controlled Clinical Trial
Allulose is a naturally occurring rare sugar that is approximately 70% as sweet as regular sugar but contains around 90% fewer calories. Monk fruit extract, which contains sweet compounds called mogrosides, is over 300 times sweeter than sugar. In the food industry, monk fruit is often combined with allulose to create a low-calorie sweetener that closely mimics the taste and texture of sugar.
Both sweeteners contain very few calories and have been studied for how they may affect blood sugar and fat levels in the body. However, there is limited research in humans, and this project aims to add to current knowledge by examining how allulose and monk fruit affect metabolism.
Purpose of the study
This study aims to investigate the following two key questions:
- Does daily supplementation with allulose alone, without changes to participants’ usual diets, improve insulin sensitivity and other metabolic biomarkers in overweight and obese adults?
- Does a blend of the rare sugar allulose with monk fruit provide different health benefits compared to allulose or fructose alone in overweight and obese adults?
The study will measure a range of metabolic biomarkers, including blood sugar, insulin, lipids, liver and kidney enzymes, inflammation, and hormones related to appetite and metabolism.
This study has received a favourable ethical opinion from the University Research Ethics Committee.
Who can take part in this study?
The study will recruit 60 healthy adults aged 18-55 years old with a body mass index between 25-40 kg/m2.
Exclusion criteria
You are not eligible to take part in the study if any of the following are applicable for you:
- Individuals with hypertension and diabetes.
- Food allergies and highly sensitive to sweeteners.
- Gastrointestinal disorders.
- Pregnant or breastfeeding women.
- BMI outside the range (25-40).
- Taking medication or supplements that may influence glucose levels
- Any history or active form of cancer.
If you meet the eligible criteria, you will be invited to come to the Hugh Sinclair Unit of Human Nutrition in the Department of Food and Nutritional Sciences for a screening visit in which the study will be described in detail. The entire study will include 2 main visits.
What will taking part in the study involve?
You will be asked to complete a Medical and Lifestyle Questionnaire and the Ethnic Group Questionnaire before being invited to a screening visit.
Screening Visit
- Initial screening visit at the Hugh Sinclair Unit of Human Nutrition in the Department of Food & Nutritional Sciences (糖心Vlog).
- You will be asked to complete a 10–12-hour overnight fast (water only) prior to the screening visit.
- Your height, weight for BMI calculation and blood pressure will be measured. A fasting blood glucose measurement will also be conducted to confirm eligibility.
- You will be randomly assigned to one of three study arms (Allulose, Fructose or Allulose – Monk fruit blend), and you will receive clear instructions on completing validated appetite and palatability questionnaires.
Main Study Visits
The study involves two visits to HSU unit for blood sample collection, with each visit lasting approximately less than 1 hour. Participants will consume their assigned sweetener daily for 3 weeks at doses determined to be safe. Each sweetener dose will be divided into two servings, taken with a cup of water before meals.
Visit 1 (Day 1, Pre-Intervention): After an overnight fast, a blood sample will be taken. You will receive your sweetener, measuring tools, and instructions. A snack will be provided before you leave.
Visit 2 (Day 21, Post-Intervention): Procedures are similar to Visit 1. A fasting blood sample will be taken, along with measurements and questionnaires. A snack will be provided before departure.
During the study, you will be asked to maintain your usual diet and activity levels and avoid other sweeteners or products containing sweeteners (e.g., aspartame, sucralose, acesulfame-K, stevia/steviol glycosides, erythritol, xylitol, or maltitol).
Study contact
Please contact nutritionvolunteers@reading.ac.uk for more information about this study.