Effect of Low Valine Diet on Body Weight and Metabolic Parameters

ConditionsOverweight/obesity Metabolic Associated Fatty Liver Disease Metabolic Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age16-80

SponsorShanghai Zhongshan Hospital

About this trial

This study aimed to explore the effects of ordinary meal replacements and low-valine meal replacements on the weight and risk of related metabolic diseases in overweight/obese patients through a randomized double-blind controlled clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 16 years old ≤ age ≤ 80 years old;

BMI ≥ 24kg/m2

Disqualifiers

Excessive drinkers (defined as: in the past 6 months, the weekly alcohol intake of men exceeds 140g, and that of women exceeds 70g);

Liver diseases caused by other reasons: such as alcoholic liver disease, acute and chronic viral hepatitis, drug-induced, immune hepatitis (AMA, SMA, ANA), cirrhosis, liver cancer, etc.;

Other diseases that affect glucose and lipid metabolism: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.;

Poorly controlled diabetic patients: HbA1c >9.5% within three months; or use of hypoglycemic drugs that may affect weight, including pioglitazone, GLP-1, SGLT2 inhibitors;

Trial design

Design model

Parallel

Treatments tested in this trial

Short-term continuous normal meal replacement
Dietary supplement
The normal meal replacement intake is calculated at 25kcal/kg body weight per person per day, with the calorie ratio for breakfast, lunch and dinner being 1:2:2. A meal replacement diet is given for 2 consecutive weeks.
Short-term continuous low-valine meal replacements
Dietary supplement
The low valine meal replacement intake is calculated at 25kcal/kg body weight per person per day, with the calorie ratio for breakfast, lunch and dinner being 1:2:2. A meal replacement diet is given for 2 consecutive weeks.
Long-term intermittent normal meal replacement
Dietary supplement
The normal meal replacement intake was calculated at 25 kcal/kg body weight per person per day, with the calorie distribution ratio of 1:2:2 for breakfast, lunch and dinner. A meal replacement diet was used for 2 consecutive days per week for 16 consecutive weeks.
Long-term intermittent low valine meal replacement
Dietary supplement
The low valine meal replacement intake was calculated at 25 kcal/kg body weight per person per day, with the calorie distribution ratio of 1:2:2 for breakfast, lunch and dinner. A meal replacement diet was used for 2 consecutive days per week for 16 consecutive weeks.

Treatment groups

48 Participants

are divided into 4 treatment groups

Group A: Short-term continuous normal meal replacement intervention groupPlacebo comparator 1 intervention

Group B: Short-term continuous low valine meal replacement intervention groupExperimental treatment 1 intervention

Group C: Long-term intermittent normal meal replacement intervention groupPlacebo comparator 1 intervention

Group D: Long-term intermittent low valine meal replacement intervention groupExperimental treatment 1 intervention