Effects of a Collagen Supplement on Quality of Life, Appetite and Glycaemic Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKing's College London
About this trial
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:
1. Consume a collagen peptide supplement for a total of 8 days at a time 2. Fill in questionnaires about quality of life, appetite, mood and energy 3. Wear continuous glucose monitors
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
In the past 4 weeks, did you feel you had a lot of energy? All of the time (1), most of the time (2), a good bit of the time (3), some of the time (4), a little of the time (5), and none of the time (6) (number 27 from SF-36 questionnaire) Version 3.0 [01/10/2025] Page 11 of 20
In the past 4 weeks, have you felt calm and peaceful? All of the time (1), most of the time (2), a good bit of the time (3), some of the time (4), a little of the time (5), and none of the time (6) (number 26 from SF-36 questionnaire)
In the past 2 weeks, did you have any difficulties with sleeping? Not at all (1), small amounts (2), moderate amounts (3), a great deal (4), an extreme amount (5), all the time (6) (number 3 from WHOQoL-100)
Disqualifiers
Participant has a history or presence of uncontrolled and/or clinically important pulmonary, cardiac, hepatic, renal, endocrine (including type 1 and 2 diabetes), hematologic, immunologic, neurologic (e.g., Alzheimer's or Parkinson's diseases), psychiatric (including unstable depression and/or anxiety disorders) or biliary disorders.
Participant has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study product [e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, severe constipation (in the opinion of the investigator), history of frequent diarrhoea, history of surgery for weight loss, gastroparesis, systemic disease that might affect gut motility according to the investigator, medication managed reflux and/or clinically important lactose intolerance.
Participant has a history of chronic insomnia (defined as insomnia at least 3 d/week over the past month), a diagnosed sleep disorder (e.g., OSA), or a chronic medical condition that may impact energy/fatigue levels, in the judgment of the investigator.
Participant is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
Trial design
Design model
Crossover
Treatments tested in this trial
Collagen peptide supplement
Dietary supplement5 g of hydrolysed collagen peptide of bovine origin in powdered form. Taken twice daily for 8 days total.
Placebo
Other intervention5 g of maltodextrin in powdered form. Taken twice daily for 8 days total.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Collagen peptide then placeboExperimental treatment 2 interventions
Group B: Placebo then collagen peptideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Quality of life scores
Quality of life (QoL) scores based on the composite scoring of the 36-item Short Form Survey (SF-36)
Time frame
Baseline and 8 daysSecondary outcomes
1
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)
Time frame
15, 30, 60, 120 and 180 minutes post-meal2
Mood
Mood measured using the Positive and Negative Affect Schedule Short Form (PANAS-SF) for positive affects (PA), negative affects (NA) and affect balance scores.
Time frame
Baseline and 7 days3
Energy and fatigue
Energy and fatigue measured using the Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) for fatigue, energy and overall scores
Time frame
Baseline and 7 days4
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.
Time frame
Baseline and 8 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
Rousselot BVBA
Collaborator
Source ClinicalTrials.gov