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| Name | Class |
|---|---|
| Rousselot BVBA | INDUSTRY |
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This is a clinical trial aimed to investigate if a collagen supplement can improve quality of life, appetite and blood sugar in overweight and obese adults aged 18-65.
Hypothesis: Consumption of a collagen supplement for 8 days will improve quality of life and improve glycaemic control in comparison with a placebo in individuals overweight or with obesity with a perceived low quality of life.
Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen peptide then placebo | Experimental | 2 x 5g of hydrolysed collagen peptide daily for 8 days then crossing over to the placebo |
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| Placebo then collagen peptide | Experimental | 2 x 5g of maltodextrin daily for 8 days then crossing over to the collagen peptide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen peptide supplement | Dietary Supplement | 5 g of hydrolysed collagen peptide of bovine origin in powdered form. Taken twice daily for 8 days total. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of life scores | Quality of life (QoL) scores based on the composite scoring of the 36-item Short Form Survey (SF-36) | Baseline and 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial appetite, hunger, fullness, satiety or desire to eat | Postprandial appetite (hunger, fullness, satiety or desire to eat), energy and mood after consumption of a standardised challenge meal, measured using a digital visual analogue scale (VAS) | 15, 30, 60, 120 and 180 minutes post-meal |
| Mood |
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Inclusion Criteria:
Subject is a healthy (as assessed by medical history) male or female adult, aged 18-65 years and overweight or obese (BMI 25 - 40 kg/m2).
Subject has an impaired quality of life, as determined by scoring at least a total of 9 on the following questions:
Participant has an email address, internet access, a compatible smartphone and is willing and able to maintain internet access throughout the trial to complete virtual visits via video conference and to engage with mobile apps to answer electronic questionnaires.
Subject is willing and able to comply with all study procedures, including consumption of the supplement daily, CGM use for 22 days total (2 x 11 days), complete standardised meal tests, and fill out health questionnaires.
Subject is willing to take a supplement of bovine animal origin.
Openness to participate in an online interview at the end of the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Cheok, PhD | Contact | +442078480313 | 80313 | alex.cheok@kcl.ac.uk |
| Ana Rodriguez-Mateos, PhD | Contact | ana.rodriguez-mateos@kcl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Research Unit (KCL, Waterloo Campus) | Recruiting | London | London | SE1 9NH | United Kingdom |
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| Placebo | Other | 5 g of maltodextrin in powdered form. Taken twice daily for 8 days total. |
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Mood measured using the Positive and Negative Affect Schedule Short Form (PANAS-SF) for positive affects (PA), negative affects (NA) and affect balance scores. |
| Baseline and 7 days |
| Energy and fatigue | Energy and fatigue measured using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) for fatigue, energy and overall scores | Baseline and 7 days |
| Sleep | Sleep measured with the Pittsburgh Sleep Quality Index (PSQI) for Global PSQI score and component scores of sleep quality, latency, duration, efficiency, disturbances and daytime dysfunction. | Baseline and 8 days |
| Glycaemic variability | Glycaemic variability, including overall mean blood glucose, fasting blood glucose, daytime mean blood glucose, daytime glucose variability (CV), % time within range and number of hypoglycaemic events, measured via a continuous glucose monitor (CGM) | From baseline to 8 days |
| Postprandial glucose response | Postprandial glucose response to a standardised breakfast expressed in difference in glucose Cmax, glucose Cmin, glucose Tmax, glucose Tmin and area under the curve, measured using continuous glucose monitor (CGM) | Continous monitoring up to 5 hours post-meal |
| Habitual diet | Habitual diet assessed via the European Prospective Investigation into Cancer and Nutrition (EPIC) food frequency questionnaire (FFQ) | Baseline only |