A Double-Blind Randomised Controlled Trial Investigating the Acute Effects of Mycoprotein on Glycaemic Control and Appetite in South Asian and Caucasian Adults With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Blood glucose
研究概览
简要总结
Diet is the cornerstone treatment to manage blood sugar in people with Type 2 Diabetes (T2D). Fibres like guar gum and protein are macronutrients that have an effect in blood sugar levels. Mycoprotein is a fungi-based food high in both dietary fibre and protein shown to have a role in regulating blood sugar levels in healthy. However, little is known about the effects of mycoprotein on blood sugar levels in people with T2D. We are interested in South Asian because they have a different blood sugar response to the same food than a Caucasian.
The main aims of the study is to assess:
- The effect of mycoprotein in different formats (soup or mince) in blood sugar levels and appetite in South Asian and Caucasian with Type 2 Diabetes.
- The effect of the combination of mycoprotein with guar gum in different formats (soup or mince) in blood sugar levels and appetite in South Asian and Caucasian with T2D.
详细描述
This is a double-blind crossover RCT. A total of 48 participants (24 Caucasian and 24 South Asian) with T2D and non insulin treated will be recruited. Participant will be randomly allocated to one of these two groups:
Group 1: Test food in form of soup and Group 2: Test food in form of mince. Once allocated in one of the groups, participant will consume in a random order 6 different test foods (soy, chicken, mycoprotein with and without guar gum) in a determined format (either as in soup or mince).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Type 2 Diabetes Mellitus without insulin treatment.
- •South Asian (Afghanistan, Bangladesh, Bhutan, Maldives, Nepal, India, Pakistan and Sri Lanka) or Caucasian Ancestry.
- •Age 18-70
- •5.5% ≤ HbA1c ≤ 9.0%
- •BMI ≤ 35.0
- •If anti-diabetic regime or lipid lowering drugs are used, they have to be stable and controlled for at least 2 months; regimes are expected to remain stable throughout the duration of the study or not being on anti-diabetic medication.
- •If on oral hypoglycaemic agent, participant should have the last dose at 8pm of the day before each study visit.
- •Willingness to comply with the study protocol, including:
- •Use of standard evening meal the day prior to the assessments
- •Refrain from alcohol consumption (24 h prior the visit) and extraneous physical exercise (72 h prior to and during the assessments).
- •Not changing physical activity routine or dietary habits for the duration of the study (except from the standard evening meal).
排除标准
- •Not diagnosed with Type 2 Diabetes Mellitus
- •Mixed ancestors
- •Taking any of the following medications:
- •Diabetic medication (except from Metformin or oral hypoglycaemic which are allowed).
- •Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. Diabetes related constipation or diarrhoea secondary to neuropathy or chronic inflammatory bowel disease, gastrectomy, etc.)
- •Significant heart (New York Heart Association class IV), hepatic (transaminase levels greater than 3 times normal) or renal disease (requiring dialysis)
- •Pancreatitis
- •Major infections (requiring antibiotics) within 3 weeks before study entry
- •Concomitant therapy with acarbose, meglitinides, insulin, systemic glucocorticoids or within 2 weeks prior to study entry
- •History of alcohol and/or drug abuse
- •Investigator's uncertainty about the willingness or ability of patient to comply with the protocol requirements
- •Participation in other nutrition trials within 3 months of study entry or drug trials within 5 months of study end
- •Current smokers
- •Allergic to test food or traces contained in the test food, breathing mould, penicillin, egg, soy
- •Asthmatics.
- •Any condition involving the imbalance of hormones
- •Hypothyroidism.
- •Weight change of ≥ 5% in the preceding 3 months
- •Shift workers
- •Vegetarian
- •Medical implants that require batteries such as heart pace makers
研究组 & 干预措施
Mycoprotein as in Soup
24 will be randomised to soup (12 caucasian and 12 south asian) in order to test raw mycoprotein. Test food will be administrated orally and allowed 15 minutes for consumption at an even pace.
干预措施: Test food containing different types of dietary protein (Other)
Mycoprotein as in Mince
24 will be randomised to mince (12 caucasian and 12 south asian) in order to test processed mycoprotein (Quorn). Test food will be administrated orally and allowed 15 minutes for consumption at an even pace.
干预措施: Test food containing different types of dietary protein (Other)
结局指标
主要结局
Blood glucose
时间窗: 180 minutes
Fasting and Postprandial blood glucose
Blood insulin
时间窗: 180 minutes
Fasting and Postprandial blood insulin
次要结局
- Subjective appetite feelings(180 minutes)
- Energy intake 72 hours post study visit(For 3 days after study visit)
- Ad libitum energy intake(At timepoint 180 minutes)