Bed and Breakfast (B&B) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02927600
• Date of registration: 14/09/2016
• Prospective Registration: No
• Primary sponsor: Nestlé
• Public title: Bed and Breakfast (B&B) Study
• Scientific title: Impact of Low Glycemic Responses Breakfast or Dinner on Postprandial Glycemia of the Subsequent Meals
• Date of first enrolment: September 2016
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02927600
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Singapore

Contacts

• Name: Christiani Jeyakumar Henry, Prof
• Affiliation: Centre for Translational Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 50 to = 70 years old years

- Chinese male and female healthy subjects having both grandparents Chinese

- Body mass index: = 18.5 to = 24.9kg/m2

- Waist circumference =90 cm for males and = 85 cm for females

- Systolic blood pressure <150 mmHg; Diastolic blood pressure <90 mmHg

- Willing and able to sign written informed consent prior to trial entry

Exclusion Criteria:

- Known Diabetes type 2, under medication

- Fasting Glycemia > 7 mmol/L

- Any clinically relevant gastrointestinal (ulcer, malabsorption), renal
(insufficiency), cardiovascular (stroke, arterial hypertension, heart disease),
metabolic disease (dyslipidemia), psychiatric disorder (depression) that would affect
the study in the opinion of the CNRC clinician, according to a detailed medical
history and a blood sampling at screening, only if deemed necessary by CNRC clinician.

- Anemia (anamnesis)

- Subjects who had a history of major gastrointestinal surgery

- Subjects who had more than 5% weight loss from baseline weight during the past three
months (more than 5% of initial weight)

- Present drug abuse or use of medications that could interfere with the treatment or
energetic metabolism including corticosteroids, growth hormone, hormonal replacement
therapy, anti-hypertensives like ACE inhibitor, thiazides and angiotensin receptors
blockers. These conditions will be screened based on subject reporting. Participants
will be asked to bring in their current medications at the time of screening, and
these will be checked by the study-staff.

- Subject allergic /intolerant to any of the test foods or any of the following common
food and ingredients: eggs, fish, milk, peanuts, and tree nuts, shellfish, soya,
wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener,
natural food colourings or flavourings etc.

- Subject on special diets especially vegetarian, high protein or weight loss program.

- Current smokers (i.e. people having smoked in the month preceding the enrolment)

- Subjects having a high alcohol consumption (more than 2 drinks/day)

- Subjects who are not willing and not able to comply with scheduled visits and the
requirements of the study procedures in the opinion of the investigators.

- Currently participating or having participated in another clinical trial within 4
weeks prior to trial start.



Age minimum: 50 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Other: High GI Dinner

Other: Low GI Breakfast

Other: High GI Breakfast

Other: Low GI Dinner

Primary Outcome(s)

Glycemia [Time Frame: 3 hours]

Secondary Outcome(s)

Plasma free fatty acids [Time Frame: 3 hours]

Plasma glycerol [Time Frame: 3 hours post meal intake]

Plasma insulin [Time Frame: 3 hours post meal intake]

Satiety [Time Frame: Every 30 minutes over the 3 hours post meal intake]

Hunger [Time Frame: Every 30 minutes over the 3 hours post meal intake]

Glycemia [Time Frame: 24h]

Plasma triglycerides [Time Frame: 3 hours post meal intake]

Plasma glucagon [Time Frame: 3 hours]

Secondary ID(s)

15.18.NRC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Clinical Nutrition Research Centre, Singapore