Assessment of Millet, Oat and Rye Porridge Breakfasts Glucose and Gastric Emptying

NCT02653274 | Completed

• 1 other identifier: F14072015 SoM SPMIC BMedSci
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Breakfast porridges are made from milled grains and are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries; rye is favoured in the Scandinavian countries whilst millet is very common in parts of India and Africa. However the nutritional value and potential metabolic and health effects may vary dramatically between different grains. For example what is the effect of the different grains on blood sugar or on how fast the stomach empties after eating the porridge and how full people feel. All these physiological responses may differ between these grains resulting in potential health benefits. RESEARCH QUESTION: The investigators hypothesise that porridges made from different grains will behave differently during the digestion and cause differences in blood glucose levels, gastric emptying and appetite. This study, which is a 4-way, randomized, cross over pilot study in healthy participants, aims to answer this research question. The participants will be asked to eat a porridge breakfasts made with oats, rye and millet of different varieties (but containing the same amount of calories), in 4 morning studies one week apart. MRI will be used to monitor the gastrointestinal fate of the breakfasts and measure gastric emptying using MRI, blood glucose levels using a finger prick test and self-reported appetite scores.

Conditions

Healthy

Keywords

MRI; blood glucose; satiety; breakfast; porridge; grains

Outcome Measures

Primary Outcomes (1)

• Blood glucose level

  Area Under the Curve of post prandial blood glucose, measured using finger prick method, up to 2h (AUC2h) postprandially

  From baseline up to 2 hours postprandially

Secondary Outcomes (1)

• Gastric volumes

  From baseline up to 2 hours postprandially

Other Outcomes (5)

• Time to peak of blood glucose

  From baseline up to 2 hours postprandially

• Appetite VAS

  From baseline up to 3 hours postprandially

• Small bowel water content

  From baseline up to 2 hours postprandially

Study Arms (4)

OATS PORRIDGE

ACTIVE COMPARATOR

Oats breakfast porridge

Other: Breakfast porridge

RYE PORRIDGE

ACTIVE COMPARATOR

Rye breakfast porridge

Other: Breakfast porridge

FINGER (RAGI) MILLET PORRIDGE

ACTIVE COMPARATOR

Finger (ragi) millet breakfast porridge

Other: Breakfast porridge

PEARL (BAJRA) MILLET PORRIDGE

ACTIVE COMPARATOR

Pearl (bajra) millet breakfast porridge

Other: Breakfast porridge

Interventions

Breakfast porridge OTHER

220 kcal breakfast porridge served with 240 mL glass of water

FINGER (RAGI) MILLET PORRIDGE; OATS PORRIDGE; PEARL (BAJRA) MILLET PORRIDGE; RYE PORRIDGE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65
• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
• Able to give informed consent
• Apparently healthy: no medical conditions which might affect study measurements (judged by study physician)

You may not qualify if:

• Use of medication which interferes with study measurements (as judged by the study physician).
• Participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
• Not used to eating breakfast
• Not used to eating three meals a day
• Reported participation in night shift work during the two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
• Strenuous exercise for more than10 hours per week.
• Consumption of ≥21 alcoholic drinks in a typical week
• Reported weight loss or gain ≥ 10 % of bodyweight during the six months period before the pre-study examination.
• Following a medically- or self-prescribed diet during the two weeks prior to the pre-study examination and until the end of the study
• Dislike of the products served as the dietary test treatments
• Any allergy or food intolerance to the test treatments
• An eating disorder as indicated by the Three factor eating questionnaire
• Not suitable for MRI scanning (e.g., presence of metal implants, infusion pumps and pacemakers) as assessed by standard MRI safety questionnaire.
• Pregnancy declared by candidate
• Antibiotic or prescribed probiotic treatment in the past 12 weeks

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham Digestive Disases Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Study Officials

• Jaber Alyami, MRes

  Nottingham Digestive Diseases Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 12, 2016
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

GB (1)