Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04323423 |
| Other study ID # |
Glycemic variability & SB |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2025 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Western University, Canada |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Rationale: Older adults spend the majority of their time in sedentary behaviours (SB). High
amounts of SB have been correlated with reduced cognitive performance. Long periods of time
spent sitting results in excessive glycemic variability, potentially contributing to
cognitive decline. Reducing/replacing SB with short intermittent bouts of light physical
activity have shown positive effects on glycemic variability. Thus, interrupting prolonged
sitting with bouts of light physical activity may regulate blood glucose and thus mitigate
cognitive decline.
Purpose: This study intends to investigate the appropriate interval frequency of
post-prandial SB reduction, by light physical activity needed to optimize total and
incremental area under the curve for glucose response in overweight older adults at risk for
glucose intolerance with mild cognitive impairment in both lab and free-living environments.
Second, this study aims to investigate the acute impact of reducing SB on glycemic
variability and its relationship with cognition.
Hypothesis: First, there will be a dose-dependent response of more frequent interruptions of
SB (more frequent intervals of light physical activity) with better glycemic control. Second,
reducing SB will result in less glycemic variability, which will translate into better levels
of cognitive performance.
Methods: Generalized linear mixed models with random intercepts will be used to evaluate the
differential effects of the experimental conditions on the selected outcomes.
Description:
This study will be a randomized crossover trial and reported in accordance with CONSORT
guidelines. The study will involve a total of three seven-day conditions (2 experimental and
1 control) with a three-week washout period in-between to minimize practice effects for a
total intervention period of nine weeks (see figure 1). Each condition will consist of one
day supervised in the laboratory followed by six at-home days, following lab protocol as
closely as possible.
Participants will be referred to the study by their physician. Interested participants will
be asked to contact the researcher by email or phone call. Interested Participants will be
invited into the lab for a familiarization session. They will be instructed to avoid
caffeine, alcohol and MVPA for 48 hours prior to this session. During this session the
following information will be obtained;
- Written informed consent
- Height using a stadiometer and weight using a standard beam scale
- Demographics questionnaire (education, ethnicity, family background, comorbidities)
- Physical Activity Readiness Questionnaire (PARQ+) (Bredin, Gledhill, Jamnik, &
Warburton, 2013)
- Resting blood pressure- will be measured once on each arm and then twice on the left arm
with an automated BP monitor The participants will be educated/familiarized on the
following;
- Cognitive assessments - Cambridge Neuropsychological Test Automated Battery (CANTAB)
- Fitting with an inclinometer (activPAL4)
Participants will be visited at their home ~72hrs prior to each condition to be fitted with
the CGM and ActivPal. They will also be instructed to avoid caffeine, alcohol and MVPA for 48
hours prior to each of the three conditions. Dinner will be consumed between 7:00 and 9:00
pm, allowing for a 10 hour fast prior to the experimental condition the next morning. All
participants will be instructed to arrive at the laboratory (with minimal activity during
commute) at approximately 7:00 am. Upon arrival, participants will be asked to use the
washroom and then rest for 30 minutes preceding a blood pressure measurement and first
cognitive assessment. The participants will undergo the CANTAB cognitive assessments (at
~7:30 am) before meal consumption. A standardized breakfast meal will be consumed at 8:00 am,
followed by lunch at 12:00 pm and dinner at 5:00 pm. Participants will be allotted 20 minutes
for full meal consumption. The CANTAB cognitive assessments will then be re-administered at
approximately 7:30 pm. Participants will be supervised throughout the conditions to ensure
adherence to the protocols and will be permitted to watch DVDs, read books, magazines,
newspapers, talk and/or work on a laptop computer. However, what they do during the first
condition will be documented and then replicated for the remaining experimental conditions.
Intensity of the bout intervals will be kept to an RPE of 6-9 using the Borg RPE scale.
Once the 12- hour laboratory component is complete, participants will be sent home (still
wearing the CGM and activPAL) with the intension of replicating the laboratory-based protocol
after each meal in their own free-living environment. Participants will track their mealtimes
by sending photos to the researcher before consumption during the 6 at home days. The
researcher will then go to the participants house on the last day (day 7) of each condition
to re-administer the CANTAB cognitive assessments and collect the CGM, and activPal. There
will then be a 3-week washout period, followed by replication of protocol for the remaining
two conditions.
