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Effect of low vs high glycaemic index diet on day-long glycaemia in healthy adults

Effect of low vs high glycaemic index diet on day-long glycaemia in healthy adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001576213
Enrollment
15
Registered
2018-09-21
Start date
2018-09-26
Completion date
2018-12-19
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic postprandial hyperglycaemia, even within the normal physiological range, may lead to adverse health outcomes in the long term. Postprandial hyperglycaemia has been shown to increase oxidative stress, and may cause glycation of protein and enzymes important for glucose metabolism. Thus finding a diet which may limit postprandial glucose excursions and overall daylong glycaemia is important for the promotion of health. Furthermore, if such a diet is found among healthy subjects, there is real impedes to further test such diet among patients with T2DM, who face daily challenges to keep their blood glucose levels within clinically acceptable ranges. Previous studies examining the effect of LGI diets on glycaemic control rarely collect data on daily long glycaemic profile of the subjects, and hence the utility of a LGI diet in the management of hyperglycaemia was not universally accepted, even though theoretically it should improve glycaemic control. Utilizing the latest technology in continuous blood glucose monitoring systems (CGMS), this proof-of-concept study will provide pilot data to support a proposal for a clinical trial amongst subjects with T2DM, which may generate the much needed evidence to support the use of a LGI diet as a first line management for T2DM.

Interventions

Two different study diets are provided i.e. low glycemic index (LGI) and high glycemic index (HGI). The subjects will be randomized to start the trial with one of the two study diets for 5 days. After that the subjects will have a 3-day wash-out period, and then they will be switched to the other diet for another 5 days. The details of the 2 study diets are as follows: Study diets We will use a meal-delivery service Eatology (http://www.eatologyasia.com) which allows customization of the foods

Two different study diets are provided i.e. low glycemic index (LGI) and high glycemic index (HGI). The subjects will be randomized to start the trial with one of the two study diets for 5 days. After that the subjects will have a 3-day wash-out period, and then they will be switched to the other diet for another 5 days. The details of the 2 study diets are as follows: Study diets We will use a meal-delivery service Eatology (http://www.eatologyasia.com) which allows customization of the foods to provide all foods during the study period. A sample 5-day menu is attached as appendix. We will discuss with their team to come up with meals and snacks that conforms to the following specifications, that are delicious and attractive: Table 1 – Nutritional composition of the study diets --------------------------------------------------------------------------------------------------------------- Parameter LGI diet HGI diet Energy (kcal/d) 1600 (F) – 2000 (M) 1600 (F) – 2000 (M) Protein (%kcal) 25 25 Carbohydrates (%kcal) 50 50 Total fats (& saturated fats) (%kcal) 25 (10) 25 (10) Fibre (g/1000kcal) 15 15 Dietary GI 40-45 60-65 Dietary Glycemic Load (GL) 110-120 150-170 --------------------------------------------------------------------------------------------------------------- F- Female, M – Male. These are approximations only. Two versions of each study diet will be formulated, one western-style and one Asian-style to cater for individual preference. The diets will be designed to be matched for macronutrient and fibre for each meal and the whole day, with a 15-25 units difference in dietary GI (i.e. the weighted average GI of all foods consumed by the carbohydrate contribution), and 40-50 units difference in dietary glycemic load (GL) (i.e. the sum of the GL from all foods). Only foods with a tested GI in the international GI database (Atkinson et al. Diabetes Care. 2010) will be used in the design of the study diets to ensure accuracy of the dietary GI which is calculated using the following formula: Dietary GL * 100 / total available carbohydrates (in grams). The study foods will be delivered to the subjects’ home or office address daily, with instructions on how to store, reheat and prepare the foods properly. After a 1-day run-in period, the subjects will be randomized to start the trial with one of the two study diets for 5 days. Then they will have a 3-day wash-out period before being switched to the other diet for another 5 days. The compositions of the diets are given in the next sub-section. All foods and drinks during the intervention periods (i.e. 2 × 5 days) will be provided, while the subjects are allowed to resume their normal diet during the run-in and wash-out period. Subjects will be instructed to eat only foods provided by the researchers through the meal-delivery service, and take and send photos before and after their meal for assessment of compliance. Subjects will be given a list of beverages they could consume which is appropriate for their assigned diet (for example, watermelon juice for HGI; most fruit juices other than watermelon juice for LGI. Water and sugar-free soft drinks are considered acceptable for both diets) . The subjects are required to take and send photos of all the drinks they taken. In the evening of the run-in period, the research assistant will insert the FreeStyle CGMS sensor into the upper arm of the subject and calibrate the reader for use. Each FreeStyle CGMS sensor can last 14-days, will automatically sample blood glucose data every 15-minutes, and can store up to 8-hours’ worth of data since the last scan. Subjects will be educated on how to scan the sensor for data, and indicate their meal-time using the inbuilt function of the reader. They will be instructed to scan for data every 6-7 hours during the time they are awake to avoid loss of data.

Sponsors

The University of Hong Kong
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Aged between 18 – 40 years 2. Body mass index between 18.5 – 23 kg/m2 3. Non-smoking 4. Non-regular alcohol drinker 5. Generally healthy with no chronic disease (including type 2 diabetes) 6. No skin sensitivity issues 7. Able to wear the subcutaneous CGMS sensor for 14 days 8. Able to receive, store and reheat the study meals according to the instructions 9. No special dietary requirement including vegetarianism and veganism 10. Ownership of a smartphone with camera function

Exclusion criteria

1. Doctor’s diagnosis of any form of impaired glucose tolerance 2. Doctor’s diagnosis of any chronic diseases 3. Individuals with impaired immunity 4. Regularly taking any form of medication (except oral contraceptives) 5. Women who are pregnant or planning to be pregnant during the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026