Millets and Oats MRI

NCT03068039 | Completed

• 1 other identifier: F12072016
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Breakfast porridges made from milled grains are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries whilst millet is very common in parts of India and Africa. However the nutritional value of different grains and their potential effects on the body may vary dramatically: for example the effect on blood sugar, on how fast the stomach empties after eating and how full people may feel. RESEARCH QUESTION: The investigators think that a pearl millet breakfast will cause a smaller rise in blood sugar compared with an oat breakfast containing the same number of calories. The investigators also think that there will be a difference in how full people feel and how fast their stomach will empty. These 2 breakfasts will be fed to each one of 26 healthy volunteers, one week apart. A safe medical imaging method (MRI) will be used to look at how quickly the breakfast empty from the stomach and how this affects the small bowel. Blood glucose levels will be measured using a finger prick test (the same as used by diabetics) and some small blood samples will be taken from a vein in the arm to measure the chemicals released by the gut after feeding gut hormones.

Conditions

Healthy

Keywords

MRI; blood glucose; porridge; breakfast; satiety; plasma peptides

Outcome Measures

Primary Outcomes (1)

• Blood glucose level

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

  From baseline up to 2 hours postprandially

Secondary Outcomes (3)

• Gastric volumes

  From baseline up to 2 hours postprandially

• Hormone peptide response and insulin

  From baseline up to 2 hours postprandially

• appetite ratings VAS scores

  From baseline up to 2 hours postprandially

Other Outcomes (5)

• Time to Peak of blood glucose

  Between baseline up to 2 hours postprandially

• Ad libitum

  From 12:00 hours to 13:00 hours on the study day

• Small bowel water content

  From baseline up to 2 hours postprandially

Study Arms (2)

OATS PORRIDGE

ACTIVE COMPARATOR

Oats breakfast porridge 220 kcal served with 240 mL water

Other: Oats breakfast porridge

PEARL (BAJRA) MILLET PORRIDGE

ACTIVE COMPARATOR

Pearl (bajra) millet breakfast porridge isoenergetic (220 kcal) served with 300 mL water to make it also isovolumteric with the Oats arm

Other: Pearl (bajra) breakfast porridge

Interventions

Oats breakfast porridge OTHER

Isoenergetic and isovolumteric oats breakfast porridge

OATS PORRIDGE

Pearl (bajra) breakfast porridge OTHER

Isoenergetic and isovolumteric pearl (bajra) breakfast porridge

PEARL (BAJRA) MILLET 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) ≥ 18.5 and ≤ 24.9 kg/m2
• Able to give informed consent
• Apparently healthy: no medical conditions which might affect study measurements (judged by the investigators)

You may not qualify if:

• Restrained eating behaviour as determined by Eating habits and SCOFF screening questionnaires
• Not used to eating breakfast
• Not used to eating three meals a day
• 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.
• 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
• 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 , University of Nottingham

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Alyami J, Whitehouse E, Yakubov GE, Pritchard SE, Hoad CL, Blackshaw E, Heissam K, Cordon SM, Bligh HFJ, Spiller RC, Macdonald IA, Aithal GP, Gowland PA, Taylor MA, Marciani L. Glycaemic, gastrointestinal, hormonal and appetitive responses to pearl millet or oats porridge breakfasts: a randomised, crossover trial in healthy humans. Br J Nutr. 2019 Nov 28;122(10):1142-1154. doi: 10.1017/S0007114519001880.

  PMID: 31709970 DERIVED

Study Officials

• Jaber Alyami, MRes

  Nottingham Digestive Disases Centre , University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

  STUDY DIRECTOR

• Luca Marciani

  Nottingham Digestive Disases Centre , University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

  PRINCIPAL INVESTIGATOR

• Moira Taylor

  School of Life Sciences, University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

  PRINCIPAL INVESTIGATOR

• Penny A Gowland

  Sir Peter Mansfield Imaging Centre, University of Nottingham, Nottingham NG7 2RD, U.K.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blind (Investigator blind)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: October 25, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)