Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans

L

Loughborough University

Status

Completed

Conditions

Type 2 Diabetes Mellitus
Insulin Resistance
Insulin Sensitivity

Treatments

Dietary Supplement: Yakult light

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03037918
R16-P132

Details and patient eligibility

About

Participants will be randomly allocated to either Yakult ingestion or a control group. For the first 20 days, subjects will consume their normal diet (keeping a detailed food diary throughout). On days 21-28 they will switch to a high-fat/high-calorie diet. The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic inflammation as well as decreasing whole body insulin sensitivity (as we have shown previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action / insulin sensitivity.

Enrollment

56 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Males and females
  • Aged 18-30
  • Physically active (exercising at least 3 times per week for more than 30 min at a time)
  • Non-smoker
  • Free from cardiovascular or metabolic disease
  • Weight stable for at least 6 months
  • Normal body mass index (BMI: 18.5-24.9 kg/m2)*

Compliant (i.e. understands and is willing, able and likely to comply with all study requirements)

Note: If BMI is >24.9, but body fat % (as measured by bioelectrical impedance analysis) is below 21% in males and 31% in females, then the subject may still be recruited at the PI's discretion.

Exclusion criteria

  • Using probiotic or prebiotic supplements within the previous 3 months
  • Vegetarians and vegans
  • Diagnosis of insulin resistance, pre-diabetes or full diabetes
  • Underweight (determined as BMI less than 18.5 kg/m2)
  • Overweight or obese (determined as BMI greater than 24.9 kg/m2)
  • Those on a calorie controlled diet or other dietary restrictions that would prevent them from consuming the probiotic treatment and high fat/high calorie diet.
  • Those who are unwilling to restrict their intake of fermented dairy products.
  • Those with known or suspected food intolerances, allergies or hypersensitivity
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
  • Participation in another clinical trial
  • Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 ml of blood in the previous 12 months.
  • Participants who take any form of regular medication that is known to affect either the gut microbiota and/or insulin sensitivity or who have taken any antibiotics in the previous 3 months.
  • Participants who know they would not be available for all the lab visits during the 4-week study period.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

Treatment Group
Experimental group
Description:
Participants will receive 2 x 65mL doses of Yakult light per day, for 28 days. Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.
Treatment:
Dietary Supplement: Yakult light
Control Group
No Intervention group
Description:
Participants will consume a high-fat (65% of kilocalories) high-calorie (150% of requirements) diet from day 21 to day 28.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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