Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04773483
Other study ID # 201021-B-02 Wall
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2020
Est. completion date December 17, 2021

Study information

Verified date March 2023
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In overweight individuals (BMI > 27.5 kg/m2), does daily consumption of mycoprotein containing Quorn Food products lower blood cholesterol compared with daily meat/fish consumption?


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 17, 2021
Est. primary completion date December 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 18-70 years old - BMI >27.5 kg/m2 - Non allergic to penicillin/mycoprotein - Moderate levels of physical activity or below (self-identified; NDNS servey) - Omnivores - Not currently using cholesterol lowering medication Exclusion Criteria: - <18 or >70 years old - BMI <27.5 kg/m2 - Allergies to penicillin/mycoprotein - Heavy exercisers (self idenfiied) - Vegetarian/vegans - Currently using cholesterol lowering medication

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Quorn Foods products
180 g mycoprotein (wet weight; corresponding to 45 g dry weight) per day (equates to approx. 215 g Quorn Foods products, depending on the product)
Meat/fish products
Standard meat/fish products matched to Quorn group for protein intake

Locations

Country Name City State
United Kingdom University of Exeter Exeter Devon

Sponsors (3)

Lead Sponsor Collaborator
University of Exeter Marlow Foods Ltd, NIHR Exeter Clinical Research Facility

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postabsorptive blood cholesterol (free, total, LDL, HDL) concentrations Test for intervention vs control differences in postabsorptive blood cholesterol levels (mMol) pre and post intervention 4 weeks
Secondary Postprandial blood cholesterol concentration Test for intervention vs control differences in postprandial blood cholesterol levels (mMol) pre and post intervention 3 hours
Secondary Fingerprick blood glucose concentration Test for intervention vs control differences in blood glucose concentration (mMol) in postabsorptive and postprandial state 4 weeks
Secondary Satiety Test for intervention vs control differences in satiety using a 10 centimetre 'Satiety Visual Analogue Scale' ratings, anchored by minimum to maximum response for a given aspect of satiety, where 0 cm is minimum and 10 cm is maximum 4 weeks
Secondary Hedonic visual analogue scale Test for intervention vs control differences and changes in hedonic response using 10 cm 'Hedonic Visual Analogue Scale' ratings, anchored by minimum to maximum response for a given aspect of hedonic response, where 0 cm is minimum and 10 cm is maximum 4 weeks
Secondary Gastrointestinal side-effects Test for intervention vs control differences in tolerance of diet Once weekly, over 4 weeks
Secondary Fingerprick blood c-peptide Test for intervention vs control differences in C-peptide concentration (ng/ml) in postabsorptive and postprandial state 4 weeks
Secondary Fingerprick blood triglyceride concentration Test for intervention vs control differences in blood triglyceride concentration (mMol) in postabsorptive and postprandial state 4 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03602001 - Attentive Eating for Weight Loss N/A
Recruiting NCT06269159 - The Power of 24-hour: Co-designing Intervention Components
Completed NCT03377244 - Healthy Body Healthy Souls in the Marshallese Population N/A
Completed NCT02996864 - Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II N/A
Terminated NCT03914066 - A Group-based Treatment of Overweight and Obesity in Primary Care N/A
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Completed NCT03685656 - Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers N/A
Completed NCT05051579 - A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities Phase 2
Completed NCT04611477 - Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals N/A
Active, not recruiting NCT05330247 - Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study N/A
Completed NCT03599115 - Effects of Inhibitory Control Training in Eating Behaviors N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Recruiting NCT05938894 - Train Your Brain - Executive Function N/A
Recruiting NCT05987306 - A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss N/A
Completed NCT03792685 - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention N/A
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Completed NCT04520256 - Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy Phase 2/Phase 3
Completed NCT04979234 - A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome N/A