Effect of Low Valine Diet on Body Weight and Metabolic Parameters

NCT06883578 | Recruiting

• 1 other identifier: B2024-402R
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight/obesity; Metabolic Associated Fatty Liver Disease; Metabolic Diseases

Keywords

Obesity; Dietary intervention; Low valine meal replacement

Outcome Measures

Primary Outcomes (1)

• Body weight

  From enrollment to the end of intervention at 2 weeks or 16 weeks

Secondary Outcomes (19)

• Fat mass

  From enrollment to the end of intervention at 2 weeks or 16 weeks

• Lean mass

  From enrollment to the end of intervention at 2 weeks or 16 weeks

• Fasting plasma glucose

  From enrollment to the end of intervention at 2 weeks or 16 weeks

• 2h postload plasma glucose

  From enrollment to the end of intervention at 2 weeks or 16 weeks

• Fasting insulin

  From enrollment to the end of intervention at 2 weeks or 16 weeks

Other Outcomes (3)

• Serum proteomic profiles

  From enrollment to the end of intervention at 2 weeks or 16 weeks

• Serum metabolomic profiles

  From enrollment to the end of intervention at 2 weeks or 16 weeks

• Serum lipidomic profiles

  From enrollment to the end of intervention at 2 weeks or 16 weeks

Study Arms (4)

Short-term continuous normal meal replacement intervention group

PLACEBO COMPARATOR

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.

Dietary Supplement: Short-term continuous normal meal replacement

Short-term continuous low valine meal replacement intervention group

EXPERIMENTAL

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.

Dietary Supplement: Short-term continuous low-valine meal replacements

Long-term intermittent normal meal replacement intervention group

PLACEBO COMPARATOR

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.

Dietary Supplement: Long-term intermittent normal meal replacement

Long-term intermittent low valine meal replacement intervention group

EXPERIMENTAL

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.

Dietary Supplement: Long-term intermittent low valine meal replacement

Interventions

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 normal meal replacement intervention group

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.

Short-term continuous low valine meal replacement intervention group

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 normal meal replacement intervention group

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.

Long-term intermittent low valine meal replacement intervention group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 16 years old ≤ age ≤ 80 years old;
• BMI ≥ 24kg/m2

You may not qualify if:

• 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;
• Chronic kidney disease or severe renal impairment, defined as serum creatinine greater than 2.0mg/dL;
• Serum ALT greater than 3 times the upper limit of normal;
• Life expectancy of no more than 3 years in the presence of serious health conditions;
• Those who plan to get pregnant in the near future;
• Those who cannot participate in the follow-up of the intervention due to other conditions;
• Continuously used drugs that may cause weight changes for more than 2 weeks in the past year (such as glucocorticoids, thyroid hormones, etc.);
• Participated in other clinical trials in the past 4 weeks;
• Those who had gastric volume reduction surgery or digestive tract surgery;
• Those diagnosed with any tumor disease;
• Subjects who participated in strenuous exercise or planned to change their diet structure;
• Unable to sign the informed consent form.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mingfeng Xia

CONTACT

+86 136 1182 6871; xia.mingfeng@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible subjects were enrolled according to the inclusion criteria. They will be enrolled into short-term continuous intervention or long-term intermittent intervention program according to their wishes, until the subjects of the intervention program are full.The subjects of the short-term 2-week continuous intervention or long-term 16-week intermittent intervention studies will be randomly assigned into the control meal replacement group and the low valine meal replacement group by random allocation separately, with 12 people in each group.

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 19, 2025
• Study Start: February 18, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CN (1)