Millet-based Muffins, Glycaemic Response, Insulinemic Response and Gastric Emptying
Condition: Healthy; Pre Diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Millet is a functional grain that has attracted the attention of scientists for many years
      due to its significant benefits to human health. Research has shown that millets have a high
      antioxidant capacity and polyphenol content which can contribute to a reduced risk of some
      chronic diseases such as type 2 diabetes and its complications. This study aimed to assess
      the glycaemic response (GR), insulinaemic response (IR) and gastric emptying (GE) after the
      consumption of millet-based muffins in pre-diabetic and healthy participants.

      This was a single-blind, randomized controlled crossover study in which participants consumed
      one control muffin (wheat) and one test muffin (millet). During each session, participants
      were required to consume either the test or the control muffin, consuming the alternative on
      the next visit. Then, 10 finger-prick blood samples were taken for the determination of
      glucose and insulin over 4 hours. 13Carbon (13C) sodium acetate was added to the muffins
      (control and test) in order to measure gastric emptying from the breath samples collected.
    

Detailed description: 
      This study aimed to assess the glycaemic response (GR), insulinaemic response (IR) and
      gastric emptying (GE) after the consumption of millet-based muffins in pre-diabetic and
      healthy participants. This was a single-blind, randomized controlled crossover study in which
      participants consumed one control muffin (wheat) and one test muffin (millet).This study
      investigated the effect of polyphenol-rich millet-based muffin on glycaemic response (GR),
      insulinaemic response (IR) and gastric emptying (GE) in healthy and pre-diabetic participants
      (people with prediabetes have blood glucose levels that are higher than normal but not yet
      high enough to be diagnosed as diabetes - the normal fasting blood glucose level is below 6.1
      mmol/l or 108 mg/dl).

      After potential participants have read the Participant Information Sheet (PIS) and signed the
      consent form, they were screened during the first visit to measure fasting blood glucose
      (FBG; fasting blood glucose should be between 6.1 to 6.9 mmol/l for pre-diabetic participants
      and < 6.1 mmol/l for healthy participants ).If eligible for the study, body weight and height
      and blood pressure were taken in the Functional Food Centre (currently known as Oxford
      Brookes Centre for Nutrition and Health). If the fasting blood glucose test was less than
      6.1mmol/l (participants were informed of their fasting blood glucose result and given the
      choice either to do Oral glucose tolerance test (OGTT) to check for Impaired Glucose
      Tolerance (IGT), participate in the healthy group or to be excluded). If the participant
      agreed to continue and had one or more of the pre-diabetes inclusion criteria, they could
      complete an oral glucose tolerance test (OGTT) over 2 hours.( An oral glucose tolerance test
      involves taking a fasting sample of blood and then taking a very sweet drink containing 75g
      of glucose. After having this drink participants had to stay at rest until a further blood
      sample is taken after 2 hours.) If their 2 h blood glucose result was between 7.9 to 11.0
      mmol/l, they were considered eligible to participate in the study as a prediabetic
      participant, and were asked to come for a subsequent visit in order to begin the study. If
      the participant does not have IGT, they had the option to take part in the study as a healthy
      participant.
    

Intervention name(s): Wheat muffin; Finger millet grain muffin
Intervention type(s): Other; Other
Intervention description(s): Participants consumed a control muffin made of wheat flour.; Participants consumed a test muffin made of finger millet grain and wheat flour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention